Senior Director - Law
Washington, DC jobs
Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director for its Law team who will serve as in-house legal counsel advising on state laws, legislation, and regulations that are of import to the biopharmaceutical industry, its members, and the patients it serves.
Reporting to the Senior Assistant General Counsel/Head of State Legal Affairs.
The Sr. Director will:
Serve as legal counsel for state law issues, including but not limited to prescription drug affordability boards, health insurance benefit design, and litigation and administrative law issues;
Provide and coordinate support to PhRMA's State Advocacy and Policy & Research teams;
Advocate on behalf of PhRMA and its members to state and local legislative and regulatory bodies;
Coordinate legal issue alignment with member company in-house counsel;
Manage and supervise external counsel on issues relating to state laws, legislation and regulation, and litigation issues;
Provide independent legal analysis and advice to internal clients and member company lawyers;
Provide general legal back-up for PhRMA;
Perform other duties as assigned.
Key Success Factors
PhRMA seeks a collaborative, proactive, self-starter who is passionate about access to medicines and addressing the healthcare challenges we face today. The ideal candidate for this role will be a relationship builder, problem solver, and analytical thinker. Key success factors for this role include intellectual curiosity, attention to detail, consensus-building and negotiating skills, strong interpersonal and communication skills, political sensitivity and diplomacy, and a team focus paired with the ability to work independently. The successful candidate should be adaptable, able to reprioritize/shift gears quickly, and comfortable in a high-pressure environment.
Professional Experience / Requirements
JD and member of the DC Bar with a minimum of 3+ years of progressive experience in a law firm, as counsel in a biopharmaceutical company or trade association or other non-profit, or as a public servant in a relevant government department, agency, or legislature;
Experience with state law and state legislative processes and drafting;
Experience with litigation practice and drafting briefs or other court filings;
Experience drafting regulatory comments;
Exceptional written and verbal communication skills;
Ability to manage multiple complex priorities;
Ability to communicate legal concepts and opinions to non-lawyers both verbally and in writing.
Potential Salary
$183,400 - $256,900 per annum. Salary is commensurate with experience and other compensable factors.
Who we are
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States.
Connect with PhRMA
For information on how innovative medicines save lives, please visit:
*************
******************
***********
**********************
*********************
What we offer
In addition to a highly competitive salary and bonus program, various opportunities for reward and recognition and a platform of extensive benefits, PhRMA is committed to the development and overall wellbeing of our team members. We offer traditional (medical, dental, vision, flexible spending, life, AD&D, LTD, STD, LTC) and enhanced benefits such as parental leave, a well-being program, on-site fitness facility, back-up care, an employee assistance program, and pre-tax commuting benefits. We also offer a robust 401k plan with employer contributions upon the first day of hire and immediate vesting, a generous paid time off plan, -ten paid holidays (plus inauguration day), half day Fridays preceding holidays, half day Fridays in the summer months and a paid winter break. As an organization, we work together in the office on Mondays through Thursdays and remotely on Fridays. We also work remotely in August.
We are committed to the growth and development of our team members and offer many learning opportunities including an integrated onboarding program, best-in-class leadership programming, tuition reimbursement, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in community service activities, fundraising drives and charitable athletic events.
We are committed to supporting our family of professionals at PhRMA and strive to create programs that help our team members manage the challenges of balancing a fast-paced career with their own personal goals.
Equal Opportunity Employer
PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation or veteran status in accordance with applicable federal, state and local laws governing nondiscrimination in employment.
The job description contains an overview of the activities and duties for this role. Responsibilities may change and new ones may be assigned at any time.
Auto-ApplyDirector / Senior Director - Policy & Research
Washington, DC jobs
Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Director / Senior Director for its Policy and Research team to manage research to support PhRMA policy positions and support analysis on the federal budgetary and economic impacts of U.S. federal and state policy reforms on the market for prescription medicines, including implications for access to care, utilization, spending, coverage, and reimbursement.
The individual will report to the Deputy Vice President, Policy and Research, work closely with the Vice President, Policy and Research on federal budgetary impacts, and other staff across the organization to support the development of PhRMA policy positions and strategy. Key areas of focus will be to develop and manage research and analysis to shape a policy and regulatory environment that supports a competitive market for prescription medicines, improves patient access to care, and sustains future innovation. This highly visible role requires extensive collaboration across PhRMA and with member companies.
The Director / Senior Director will:
Provide research and policy analysis to support the development of federal and state legislative and administrative policies that promote market-based solutions to improve coverage and access to prescription medicines;
Develop and coordinate research and analytics across teams assigned to support advocacy and policy development for specific market segments (e.g., Medicare Part B, Medicare Part D, Medicaid, commercial);
Conduct in-house data analysis and manage external analysis on policy priorities including impacts of policy proposals on prescription drug coverage, utilization, spending, and access.
Create and oversee the development of a broad range of policy and advocacy materials, ensuring all materials reflect the strongest evidence and analysis;
Rapidly respond to requests for information from member companies and PhRMA leadership and colleagues under tight timelines;
Develop strong relationships with member companies, consultants and PhRMA colleagues and represent PhRMA and industry interests through external engagement with policymakers and thought leaders; and
Perform other duties as assigned.
Key Success Factors
PhRMA seeks a collaborative, proactive self-starter who is passionate about innovation, access to medicines, and contributing to today's health care challenges. Key success factors for this role include a strong understanding of public and private prescription drug coverage and reimbursement policies knowledge of Congressional Budget Office methodology for legislative scoring, strong interpersonal skills and team focus paired with the ability to work independently and under short timelines. The preferred candidate will bring expertise in public policy analysis and will be focused, organized, detail oriented, responsive and diplomatic. The successful candidate should be adaptable, able to reprioritize and shift gears quickly and be comfortable in a high-pressure, fast-paced environment.
Professional Experience / Requirements
Bachelor's degree in Economics, Finance, Statistics, Epidemiology, Public Health, Health Policy or related field; Master's degree in these areas strongly preferred;
6+ years of experience in health care research, policy analysis, and legislative scoring;
Experience with health datasets such as the Medicare Current Beneficiary Survey and Medical Expenditure Panel Survey;
Understanding of HHS, Congress and federal health policy process;
Experience managing third party research efforts;
Excellent writing and editing skills;
Experience in creating advocacy support materials, such as talking points, policy briefs, etc.
Excellent qualitative and quantitative analysis skills;
Experience working with health care surveys or claims data;
Strong interpersonal and communication skills; and
Microsoft Office Excel and PowerPoint skills.
Preferred Experience
Prior experience in the federal government, trade association, or related advocacy environment, and experience with budget estimates at CBO, OMB, OACT preferred;
Prior experience at a biopharmaceutical company, pharmacy, health plan, or other related industry environment;
Experience working with statistical software, such as SAS.
Potential Salary
Director: $132,600 - $182,300 / Senior Director: $169,300 - $237,100 per annum. Salary is commensurate with experience and other compensable factors.
Who we are
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States.
Connect with PhRMA
For information on how innovative medicines save lives, please visit:
*************
******************
***********
**********************
*********************
What we offer
In addition to a highly competitive salary and bonus program, various opportunities for reward and recognition and a platform of extensive benefits, PhRMA is committed to the development and overall wellbeing of our team members. We offer traditional (medical, dental, vision, flexible spending, life, AD&D, LTD, STD, LTC) and enhanced benefits such as parental leave, a well-being program, on-site fitness facility, back-up care, an employee assistance program, and pre-tax commuting benefits. We also offer a robust 401k plan with employer contributions upon the first day of hire and immediate vesting, a generous paid time off plan, ten paid holidays (plus inauguration day), half day Fridays preceding holidays, half day Fridays in the summer months and a paid winter break. As an organization, we work together in the office on Mondays through Thursdays and remotely on Fridays. We also work remotely in August.
We are committed to the growth and development of our team members and offer many learning opportunities including an integrated onboarding program, best-in-class leadership programming, tuition reimbursement, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in community service activities, fundraising drives and charitable athletic events.
We are committed to supporting our family of professionals at PhRMA and strive to create programs that help our team members manage the challenges of balancing a fast-paced career with their own personal goals.
Equal Opportunity Employer
PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation or veteran status in accordance with applicable federal, state and local laws governing nondiscrimination in employment.
The job description contains an overview of the activities and duties for this role. Responsibilities may change and new ones may be assigned at any time.
Auto-ApplySenior Director Medical Affairs, Movement Disorders
Illinois jobs
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!
Remote Opportunity - Open to candidates anywhere in the United States
SUMMARY:
The Senior Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the Vice President, Rare Neurology, US Medical Affairs. As a strategic partner and leader collaborating across research, development, and commercial functions, the Director ensures the alignment of Multiple System Atrophy (MSA) strategies with the needs of patients, healthcare professionals, payers and policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a Medical Affairs team that delivers world-class engagement, practice-defining collaborations, and persuasive evidence.
ESSENTIAL FUNCTIONS:
Represent Lundbeck as a credible and knowledgeable scientific leader in the field of Movement Disorders, collaborate as a peer with external stakeholders to drive scientific leadership, improvement in diagnosis and access to treatment
Develop plans to achieve ambitious business objectives; execute aligned medical strategies and tactics with urgency and measurable impact
Shape evidence generation efforts to differentiate and expand access to treatment, working closely with global colleagues to support the design, protocol review and execution of Phase IIIb/IV studies, manage investigator-initiated (IIT) proposals
Lead and plan national advisory boards to inform and shape medical strategy
Develop and communicate high-quality medical content, compelling scientific narratives, engaging congress and field materials
Provide constructive input to optimize global publication strategy and represent US needs and priorities
Identify and create new opportunities to drive value for external stakeholders
Serve as medical reviewer and internal subject matter expert for promotional and nonpromotional materials
Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific alignment with integrated plans
Drive an ambitious external engagement agenda by identifying, developing and maintaining strong networks with key external stakeholders including investigators, thought leaders and healthcare practitioners; foster productive partnerships, engage through scientific congresses, and scientific exchange
Partner closely with Field Medical on overall strategy for external engagement, insights gathering and reporting, and translate insights to action
Remain intimately aware and abreast of evolving disease area trends and competitor activities to continuously anticipate changes and assess impact to US and Global scientific and brand strategy
REQUIRED EDUCATION, EXPERIENCE, AND SKILLS:
Doctoral Degree (PhD, PharmD, or MD.)
8+ years of non-field-based Medical Affairs experience in the pharmaceutical or biotech industry, at least 3 years leading medical strategy in a for a rare asset
Managed full time direct reports for at least 3 years
Led the development and execution of integrated medical strategies within rare neurology and across broader rare disease therapeutic areas
Directed medical affairs strategy, launch planning, evidence generation, and scientific communication initiatives to advance medical and corporate objectives
Led high-quality advisory boards and roundtables in rare diseases, ensuring capture of relevant and actionable insights
Oversaw the design and delivery of Medical Education programs (CME and non-CME) to enhance disease understanding and clinical engagement
Provided strategic oversight for evidence generation efforts, including study design, registries, real-world evidence initiatives, and publication planning
Served as senior medical reviewer for promotional and non-promotional materials, ensuring alignment with compliance standards and scientific accuracy
Championed the collection, synthesis, and application of scientific and clinical insights to inform strategic decision-making and cross-functional alignment
Recognized for strong scientific acumen, critical thinking, and the ability to drive data-driven, patient-centered strategies
Built and led high-performing teams, fostering a culture of collaboration, accountability, and innovation in a dynamic, fast-paced environment
Partnered effectively across global and regional teams to ensure alignment between medical, commercial, and regulatory priorities
Upheld the highest ethical standards, integrity, and professionalism in representing the organization to both internal and external stakeholders
RARE DISEASE CAPABILITIES AND LEADERSHIP
Recognized as an authentic, long-term leader within the rare disease community - fostering trust and collaboration with patient advocacy groups (PAGs), clinicians, and industry partners
Demonstrated track record of building strategic alliances with PAGs and patient families as research collaborators, ensuring patient perspectives shape scientific priorities
Trusted and respected voice within the rare disease ecosystem, known for transparency, empathy, and sustained community engagement
Deep expertise in rare disease best practices, including advocacy relations, policy and access strategy, , and patient support program development
Strategically guided innovative partnerships and thought-leadership initiatives with rare disease alliances and policy groups (e.g., Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence)
Highly proactive and solutions-oriented, capable of driving organizational progress in ambiguous or unstructured settings
Brings a mission-driven mindset - combining scientific rigor with empathy, credibility, and purpose to inspire cross-functional and external collaboration
Maintains a broad and influential network within the rare disease ecosystem, effectively mobilizing partnerships and coalitions to accelerate shared goals
PREFERRED EDUCATION, EXPERIENCE, AND SKILLS:
Strong Preference to be based in Deerfield, IL Office
8+ years of non-field-based Medical Affairs industry experience in rare disease, experience preparing for and launching a rare neurology asset
5+ years managing a team of full-time direct reports
Demonstrated managerial success of a US Medical Affairs team through launch
Movement disorder specialist with established relationships within the movement disorder KOL and advocacy communities
Direct accountability for creating and managing a real-world rare disease registry partnership with KEEs
Direct accountability for phase IIIb/IV study design and execution for a rare disease
Past responsibility for managing IIT process
FDA regulatory knowledge and direct exposure
TRAVEL:
Willingness/ability to travel up to 35% domestically. Occasional international travel may be required.
If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $270,000 - $310,000 and eligibility for a 30% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
Senior Director Medical Affairs, Movement Disorders
Deerfield, IL jobs
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!
Remote Opportunity - Open to candidates anywhere in the United States
SUMMARY:
The Senior Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the Vice President, Rare Neurology, US Medical Affairs. As a strategic partner and leader collaborating across research, development, and commercial functions, the Director ensures the alignment of Multiple System Atrophy (MSA) strategies with the needs of patients, healthcare professionals, payers and policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a Medical Affairs team that delivers world-class engagement, practice-defining collaborations, and persuasive evidence.
ESSENTIAL FUNCTIONS:
* Represent Lundbeck as a credible and knowledgeable scientific leader in the field of Movement Disorders, collaborate as a peer with external stakeholders to drive scientific leadership, improvement in diagnosis and access to treatment
* Develop plans to achieve ambitious business objectives; execute aligned medical strategies and tactics with urgency and measurable impact
* Shape evidence generation efforts to differentiate and expand access to treatment, working closely with global colleagues to support the design, protocol review and execution of Phase IIIb/IV studies, manage investigator-initiated (IIT) proposals
* Lead and plan national advisory boards to inform and shape medical strategy
* Develop and communicate high-quality medical content, compelling scientific narratives, engaging congress and field materials
* Provide constructive input to optimize global publication strategy and represent US needs and priorities
* Identify and create new opportunities to drive value for external stakeholders
* Serve as medical reviewer and internal subject matter expert for promotional and nonpromotional materials
* Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific alignment with integrated plans
* Drive an ambitious external engagement agenda by identifying, developing and maintaining strong networks with key external stakeholders including investigators, thought leaders and healthcare practitioners; foster productive partnerships, engage through scientific congresses, and scientific exchange
* Partner closely with Field Medical on overall strategy for external engagement, insights gathering and reporting, and translate insights to action
* Remain intimately aware and abreast of evolving disease area trends and competitor activities to continuously anticipate changes and assess impact to US and Global scientific and brand strategy
REQUIRED EDUCATION, EXPERIENCE, AND SKILLS:
* Doctoral Degree (PhD, PharmD, or MD.)
* 8+ years of non-field-based Medical Affairs experience in the pharmaceutical or biotech industry, at least 3 years leading medical strategy in a for a rare asset
* Managed full time direct reports for at least 3 years
* Led the development and execution of integrated medical strategies within rare neurology and across broader rare disease therapeutic areas
* Directed medical affairs strategy, launch planning, evidence generation, and scientific communication initiatives to advance medical and corporate objectives
* Led high-quality advisory boards and roundtables in rare diseases, ensuring capture of relevant and actionable insights
* Oversaw the design and delivery of Medical Education programs (CME and non-CME) to enhance disease understanding and clinical engagement
* Provided strategic oversight for evidence generation efforts, including study design, registries, real-world evidence initiatives, and publication planning
* Served as senior medical reviewer for promotional and non-promotional materials, ensuring alignment with compliance standards and scientific accuracy
* Championed the collection, synthesis, and application of scientific and clinical insights to inform strategic decision-making and cross-functional alignment
* Recognized for strong scientific acumen, critical thinking, and the ability to drive data-driven, patient-centered strategies
* Built and led high-performing teams, fostering a culture of collaboration, accountability, and innovation in a dynamic, fast-paced environment
* Partnered effectively across global and regional teams to ensure alignment between medical, commercial, and regulatory priorities
* Upheld the highest ethical standards, integrity, and professionalism in representing the organization to both internal and external stakeholders
RARE DISEASE CAPABILITIES AND LEADERSHIP
* Recognized as an authentic, long-term leader within the rare disease community - fostering trust and collaboration with patient advocacy groups (PAGs), clinicians, and industry partners
* Demonstrated track record of building strategic alliances with PAGs and patient families as research collaborators, ensuring patient perspectives shape scientific priorities
* Trusted and respected voice within the rare disease ecosystem, known for transparency, empathy, and sustained community engagement
* Deep expertise in rare disease best practices, including advocacy relations, policy and access strategy, , and patient support program development
* Strategically guided innovative partnerships and thought-leadership initiatives with rare disease alliances and policy groups (e.g., Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence)
* Highly proactive and solutions-oriented, capable of driving organizational progress in ambiguous or unstructured settings
* Brings a mission-driven mindset - combining scientific rigor with empathy, credibility, and purpose to inspire cross-functional and external collaboration
* Maintains a broad and influential network within the rare disease ecosystem, effectively mobilizing partnerships and coalitions to accelerate shared goals
PREFERRED EDUCATION, EXPERIENCE, AND SKILLS:
* Strong Preference to be based in Deerfield, IL Office
* 8+ years of non-field-based Medical Affairs industry experience in rare disease, experience preparing for and launching a rare neurology asset
* 5+ years managing a team of full-time direct reports
* Demonstrated managerial success of a US Medical Affairs team through launch
* Movement disorder specialist with established relationships within the movement disorder KOL and advocacy communities
* Direct accountability for creating and managing a real-world rare disease registry partnership with KEEs
* Direct accountability for phase IIIb/IV study design and execution for a rare disease
* Past responsibility for managing IIT process
* FDA regulatory knowledge and direct exposure
TRAVEL:
* Willingness/ability to travel up to 35% domestically. Occasional international travel may be required.
* If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $270,000 - $310,000 and eligibility for a 30% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
Senior Director Medical Affairs, Movement Disorders
Deerfield, IL jobs
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!
**Remote Opportunity - Open to candidates anywhere in the United States**
**SUMMARY:**
The Senior Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the Vice President, Rare Neurology, US Medical Affairs. As a strategic partner and leader collaborating across research, development, and commercial functions, the Director ensures the alignment of Multiple System Atrophy (MSA) strategies with the needs of patients, healthcare professionals, payers and policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a Medical Affairs team that delivers world-class engagement, practice-defining collaborations, and persuasive evidence.
**ESSENTIAL FUNCTIONS:**
+ Represent Lundbeck as a credible and knowledgeable scientific leader in the field of Movement Disorders, collaborate as a peer with external stakeholders to drive scientific leadership, improvement in diagnosis and access to treatment
+ Develop plans to achieve ambitious business objectives; execute aligned medical strategies and tactics with urgency and measurable impact
+ Shape evidence generation efforts to differentiate and expand access to treatment, working closely with global colleagues to support the design, protocol review and execution of Phase IIIb/IV studies, manage investigator-initiated (IIT) proposals
+ Lead and plan national advisory boards to inform and shape medical strategy
+ Develop and communicate high-quality medical content, compelling scientific narratives, engaging congress and field materials
+ Provide constructive input to optimize global publication strategy and represent US needs and priorities
+ Identify and create new opportunities to drive value for external stakeholders
+ Serve as medical reviewer and internal subject matter expert for promotional and nonpromotional materials
+ Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific alignment with integrated plans
+ Drive an ambitious external engagement agenda by identifying, developing and maintaining strong networks with key external stakeholders including investigators, thought leaders and healthcare practitioners; foster productive partnerships, engage through scientific congresses, and scientific exchange
+ Partner closely with Field Medical on overall strategy for external engagement, insights gathering and reporting, and translate insights to action
+ Remain intimately aware and abreast of evolving disease area trends and competitor activities to continuously anticipate changes and assess impact to US and Global scientific and brand strategy
**REQUIRED EDUCATION, EXPERIENCE, AND SKILLS:**
+ Doctoral Degree (PhD, PharmD, or MD.)
+ 8+ years of non-field-based Medical Affairs experience in the pharmaceutical or biotech industry, at least 3 years leading medical strategy in a for a rare asset
+ Managed full time direct reports for at least 3 years
+ Led the development and execution of integrated medical strategies within rare neurology and across broader rare disease therapeutic areas
+ Directed medical affairs strategy, launch planning, evidence generation, and scientific communication initiatives to advance medical and corporate objectives
+ Led high-quality advisory boards and roundtables in rare diseases, ensuring capture of relevant and actionable insights
+ Oversaw the design and delivery of Medical Education programs (CME and non-CME) to enhance disease understanding and clinical engagement
+ Provided strategic oversight for evidence generation efforts, including study design, registries, real-world evidence initiatives, and publication planning
+ Served as senior medical reviewer for promotional and non-promotional materials, ensuring alignment with compliance standards and scientific accuracy
+ Championed the collection, synthesis, and application of scientific and clinical insights to inform strategic decision-making and cross-functional alignment
+ Recognized for strong scientific acumen, critical thinking, and the ability to drive data-driven, patient-centered strategies
+ Built and led high-performing teams, fostering a culture of collaboration, accountability, and innovation in a dynamic, fast-paced environment
+ Partnered effectively across global and regional teams to ensure alignment between medical, commercial, and regulatory priorities
+ Upheld the highest ethical standards, integrity, and professionalism in representing the organization to both internal and external stakeholders
**RARE DISEASE CAPABILITIES AND LEADERSHIP**
+ Recognized as an authentic, long-term leader within the rare disease community - fostering trust and collaboration with patient advocacy groups (PAGs), clinicians, and industry partners
+ Demonstrated track record of building strategic alliances with PAGs and patient families as research collaborators, ensuring patient perspectives shape scientific priorities
+ Trusted and respected voice within the rare disease ecosystem, known for transparency, empathy, and sustained community engagement
+ Deep expertise in rare disease best practices, including advocacy relations, policy and access strategy, , and patient support program development
+ Strategically guided innovative partnerships and thought-leadership initiatives with rare disease alliances and policy groups (e.g., Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence)
+ Highly proactive and solutions-oriented, capable of driving organizational progress in ambiguous or unstructured settings
+ Brings a mission-driven mindset - combining scientific rigor with empathy, credibility, and purpose to inspire cross-functional and external collaboration
+ Maintains a broad and influential network within the rare disease ecosystem, effectively mobilizing partnerships and coalitions to accelerate shared goals
**PREFERRED EDUCATION, EXPERIENCE, AND SKILLS:**
+ Strong Preference to be based in Deerfield, IL Office
+ 8+ years of non-field-based Medical Affairs industry experience in rare disease, experience preparing for and launching a rare neurology asset
+ 5+ years managing a team of full-time direct reports
+ Demonstrated managerial success of a US Medical Affairs team through launch
+ Movement disorder specialist with established relationships within the movement disorder KOL and advocacy communities
+ Direct accountability for creating and managing a real-world rare disease registry partnership with KEEs
+ Direct accountability for phase IIIb/IV study design and execution for a rare disease
+ Past responsibility for managing IIT process
+ FDA regulatory knowledge and direct exposure
**TRAVEL:**
+ Willingness/ability to travel up to 35% domestically. Occasional international travel may be required.
+ If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $270,000 - $310,000 and eligibility for a 30% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on ourcareer site (***************************************************************************************************************** . Applications accepted on an ongoing basis.\#LI-LM1, #LI-Remote
**Why Lundbeck**
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on theU.S. career site (***************************************************************************************************************** .
_Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit theU.S. career site (*********************************************************************** ._
_Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates inE-Verify (****************************************************************************************************************************** ._
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
Senior Director of Partner Success
Remote
Mantra Health is an award-winning digital mental health provider for colleges and universities. On a mission to make evidence-based mental health care more accessible to students, Mantra Health partners with higher education institutions and health insurance plans to provide undergraduate and graduate students with virtual therapy, psychiatry, crisis care, and wellness content. Mantra Health aims to provide digital and clinical services to 40 million young adults by augmenting high-quality, evidence-based clinical services with seamless campus integration. We were named a Rising Star by the 2022 UCSF Health Hub Digital Health Awards in Mental & Behavioral Health. Mantra Health solutions have been deployed across over 130 college and university campuses, including Penn State University, Massachusetts Institute of Technology, Miami Dade College, and UC Berkeley, serving over 1 million students.
Opportunity for Impact
We're looking for a Sr. Director of Partner Success to join and lead our growing Partner Success team. The ideal candidate will provide leadership to the existing Partner Success Team. The ideal person for this role will form strong connections with our campus partners in higher education over time, allowing those partners to deepen their relationships with us. They will guide and support their team on best practices and act as an escalation point for their team. They will work closely with the Partner Success team to drive retention and expansion while identifying cross-sell opportunities for new products. The Sr. Director of Partner Success will work cross-functionally to improve systems and engagement for the Partner Success team by improving CRM workflows, KPIs, reporting, partner health checks and scoring, and forecasting. We're seeking empathetic leaders who are skilled relationship managers and proactive, effective communicators. We're excited about candidates from all backgrounds who are passionate about our mission to make mental healthcare accessible and available to young adult students in the U.S.
What You'll Do
Help improve and implement updates to a comprehensive customer engagement strategy in alignment with company objectives
Partner with the Go-To-Market leadership team to use the collective best practices to ensure customer growth, success, and retention
Own retention and expansion performance
Establish a trusted advisor relationship to gain long-term client relationships with partners
Develop an annual plan to hit net dollar retention (NDR) goals, as well as expansion goals
Coach CSMs to identify growth opportunities and drive accountability
Define KPI dashboards and performance tracking systems
Champion CRM adoption for renewal and expansion forecasting
Provide leadership and guidance for the Partner Success Team, as well as day-to-day people management
Lead weekly meetings to ensure up-to-date enablement of the team
Act as an escalation and de-escalation point for your team, internal cross-functional stakeholders, and Mantra Health's partners
Help improve an account risk and health monitoring system for Mantra's partners
Partner with leadership in quarterly business review meetings (QBRs)
Guide and oversee your team's RFP response processes as appropriate
Become an expert on Mantra's solutions and our market
Champion the use of Salesforce to manage accounts, opportunities, contacts, and renewals
Travel for customer visits and internal meetings; approximately a few days per month, on average
Who You Are
Experience leading Customer Success teams supporting renewals and expansion within higher education accounts
Experienced in complex customer success, specifically managing accounts with multi-persona stakeholders with ongoing customer success demands
High degree of proficiency in forecasting renewals and expansion
Track record of leading and coaching a Partner Success / Customer Success team to measurably improve performance over time
Action-oriented and able to cultivate business relationships with experience collaborating and orchestrating GTM resources, including Marketing support
Experience hiring and onboarding talent into a complex customer program
Can thrive on taking initiative in a fast-moving, growth environment while generating energy from presenting to small and large groups of partners
Has the ability to conceive and execute long-term account strategies while tackling immediate challenges
Can take a learning approach, be organized and comfortable using a modern sales tech stack
Has success selling at an early-stage company that launches and monetizes add-on products
Can demonstrate proven success at achieving and exceeding customer retention and upselling goals
Proficiency with project management, especially around coordinating new implementations Experience in higher education is required
Clear understanding of recurring revenue metrics and reporting
Prior experience bringing a new product to market is a plus
Why Choose Mantra
A chance to collaborate with a passionate, dedicated, and innovative team focused on elevating the student experience through mental healthcare.
Opportunities for professional growth through mentorship, cross-functional collaboration and skill development.
Competitive salary and benefits, including PTO, equity, health insurance, etc.
Compensation & Benefits
Compensation: $220,000 - $240,000 OTE
Pay range may vary by location and is commensurate with experience and market rates.
At Mantra, our distributed team is our secret sauce that allows us to support our mission everyday. We're collaborative, empathetic, and curious. We take time to celebrate our wins and learn from our mistakes.
Each full-time employee at Mantra enjoys:
Stock Options
Medical, vision, and dental coverage for employees, spouses, and dependents
401(k)
Flexible work location
Generous PTO, sick days, jury duty days, and bereavement. Three week sabbatical and $3,000 stipend after five years of continuous full-time employment
Inclusive parental leave, equal for all parents
$1,000 new-parent mental wellness benefit
Commuter card, if you commute
Access to One Medical
Healthcare & Dependent Care FSA
Mantra health is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Auto-ApplyLead, R&D Business Analysis (Director)
Northbrook, IL jobs
**Lead, R&D Business Analysis** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
We are seeking a dynamic and experienced leader to join our team. The Lead, R&D Business Analysis plays a dual leadership role in driving the digital transformation of pharmaceutical R&D. This role requires strong people management and cross-functional leadership skills, a collaborative mindset, and the ability to drive results in a fast-paced environment.
The primary responsibility of the Lead, R&D Business Analysis is to serve as a people manager, responsible for developing talent, managing team capacity, and fostering excellence across the community of Business Analysts who support R&D digital initiatives. The Lead, R&D Business Analysis will be assigned to lead a cross-functional team for the management of a portfolio of relevant R&D digital capabilities. They will be working across scientific, operational, data, and technology domains to define vision, guide execution, and ensure business value realization for key digital products and platforms
**Essential Job Responsibilities:**
+ Manage a team of Business Analysts who support digital initiatives across R&D.
+ In conjunction with Pod Captains, manage resource allocation and capacity planning to meet portfolio demands while balancing team workload and priorities.
+ Coach and mentor team members to strengthen core capabilities in Astellas values and behaviors, R&D business analysis, digital product management, stakeholder engagement and communication, and agile delivery.
+ Foster a collaborative and innovative team culture, encouraging open communication and idea sharing
+ Partner with HR and functional leaders to attract, retain, and develop top digital talent aligned with evolving R&D business needs.
+ Lead a cross-functional matrixed team focused on a specific portfolio of digital capabilities for R&D, ensuring alignment with relevant functional goals and company objectives.
+ Lead the development and monitoring of Objectives and Key Results (OKRs).
+ Collaborate with cross-functional stakeholders and R&DX leadership team to set OKRs, track progress, and address concerns.
+ Continue to mature agile way of working, through ceremonies including sprint planning, backlog refinement, retrospectives, regular stand-ups, and use of our Agile Enterprise applications (Azure DevOps) for managing epics, features, user stories and sprints.
+ Monitor project timelines, budgets, and resources, ensuring projects are delivered on time and within budget.
+ Collaborate with business stakeholders and technical teams to identify innovation opportunities including the use of AI, GenAI, Automation and Advanced Analytics.
**Qualifications Required:**
+ Bachelor's degree in Life Sciences, Business Administration, Computer Science, Systems Engineering, or related field. Advanced degree (MS, MBA, PhD) or equivalent experience preferred.
+ 10+ years of experience in business analysis or digital product management within pharmaceutical R&D and/or management consulting group focused on R&D in life science5+ years of experience in people leadership, including managing and developing high-performing teams.
+ Demonstrated experience leading cross-functional digital initiatives or product portfolios in complex, matrixed environments.
+ Strong understanding and experience of Agile methodologies and ways of working.
+ Demonstrated knowledge of the R&D lifecycle and related digital ecosystems for effective coaching and capacity management of direct reports.
+ Ability to partner with business stakeholders across functions.
+ Excellent communication and interpersonal skills.
+ Strong problem-solving skills and a proactive approach to challenges.
+ May require up to 10% international travel.
**Preferred:**
+ Experience leading digital capabilities in R&D or regulated scientific environments.
+ Experience in Agile Development, Product Management and Software Development Life Cycles including requirements specifications development and user acceptance testing for computer systems in a GxP environment.
+ Familiarity with emerging technologies such as GenAI, advanced analytics, and intelligent automation in R&D use cases.
+ Demonstrated ability to drive business value realization and adoption of digital products.
**Working Environment:**
Hybrid work arrangements (on-site/work from home) from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
**Salary Range:** $170,450 -$267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations).
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Company-paid fleet vehicle for eligible positions
+ Referral bonus program
**\#LI-CH1**
Category Research & DevelopmentX
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Director, External Expert Strategy & Engagement
Columbus, OH jobs
The Director, External Expert Strategy & Engagement is a critical role responsible for defining, standardizing, and overseeing the company's global strategy for engaging a broad spectrum of external stakeholders. This includes Key Opinion Leaders (KOLs), Digital Opinion Leaders (DOLs), Payers/Access Stakeholders, Academic/Integrated Health Systems, Patients/Caregivers, and Patient Advocacy Groups. The role is accountable for establishing the governance, process clarity, and technological infrastructure necessary to ensure coordinated, high-value, and non-transactional interactions across all functional areas, distinguishing tactics based on the asset lifecycle stage (Early vs. In-line). This position reports directly to the Executive Director of External Engagement and Field Excellence.
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**Key Responsibilities:**
**Strategic Governance and Accountability**
+ Establish clear accountability and process ownership for all external expert engagement activities, defining roles and responsibilities across the Medical Affairs (GMA) function to address the current pain point of limited clarity on accountabilities and responsibilities.
+ Develop and implement a standardized global strategy for external engagement that distinctly tailors objectives based on asset lifecycle (e.g., Early Asset engagement must focus on obtaining input from KOLs and Payers on trial design and clinical/economic value).
**System and Data Management**
+ Coordinate with stakeholder engagement liaisons (from GMA, Commercial, Clinical Development, Market Access, Patient Advocacy and Stakeholder Management, Corporate Communications, and Government Affairs) and IT to migrate multiple, overlapping stakeholder lists.
+ Drive process adherence for the consistent upkeep and governance of the centralized external stakeholder list, ensuring the database accurately tracks engagement across all categories of stakeholders (e.g., Patients/Caregivers, Academic Systems, Digital Opinion Leaders).
+ Champion the use of the centralized system to track all medical expert interactions, contact attempts, and strategic insights captured.
**Coordination and Best Practices**
+ Facilitate connections between the designated primary stakeholder lead contact and any internal team member seeking subsequent outreach to prevent multiple concurrent communications and requests.
+ Encourage and mandate best practices for GMA preparation before any stakeholder outreach, ensuring all engagement is high-quality and strategically aligned.
+ Partner with the Training team to develop standardized training and resources for internal teams on proper engagement protocols, compliance guidelines, and use of the centralized Veeva system, highlighting the specific goals for engaging each stakeholder group.
+ Collaborate with Global Training Lead to coordinate any needed training on external engagement processes and/or capabilities.
+ Consider technology and AI to support workflow improvement.
**Qualifications:**
**Education and Experience:**
+ Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent).
+ Minimum of 8 - 10 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 5 years in Global Medical Affairs, Strategic Operations, or an equivalent function focused on External Expert/KOL Engagement.
+ Proven experience in designing, implementing, and managing global engagement processes across multiple therapeutic areas and across different asset lifecycle stages.
+ Demonstrated success in leading a complex cross-functional project (e.g., system migration, process standardization) involving IT and multiple business units.
**Skills and Competencies:**
+ Exceptional ability to drive process governance and change management across a global matrix organization.
+ Superior Stakeholder Management and influencing skills, capable of gaining consensus and driving compliance among diverse functional leaders (Commercial, Clinical, Global Medical Affairs).
+ Strong technological acumen with proven experience working with Veeva or similar management platforms for centralized data management.
+ Excellent communication and presentation skills, with the ability to articulate the strategic value of coordinated external engagement to senior executive leadership.
+ Motivated and solution-oriented, with a clear focus on simplifying complex processes for end-users.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Clinical Development - Nephrology & Immunology
Columbus, OH jobs
**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.
**Culture**
As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.
Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.
**Pipeline**
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
You can learn more about Otsuka by clicking here! (*******************************************
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**Position Summary**
Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.
**Key Job Responsibilities**
+ Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
+ Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
+ Serve as the medical lead and subject matter expert for assigned indications.
+ Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
+ Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
+ Collaborate with regulatory affairs on interactions with global health authorities.
+ Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
+ Lead clinical discussions with KOLs and advisory boards.
+ Develop clinical documents including medical monitoring plans, asset development plans
+ Contribute to development of publication plans and review scientific manuscripts for publications.
+ Mentor and provide leadership to junior team members within the organization.
+ Support business development activities through medical due diligence and evaluation of external opportunities.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet company
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
+ Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
+ An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
+ Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
+ Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
**Physical Demands and Work Environment**
+ Travel (~30-35%)
+ See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications CNS
Columbus, OH jobs
The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy.
The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy
+ Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver high quality publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Medical Information Content Generation:**
+ Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents.
+ Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements.
+ Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels.
+ Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies.
+ Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery.
+ Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement.
+ Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization.
+ Consider technology and AI to support workflow improvement
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus.
**Skills and Competencies:**
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications, Nephrology & Immunology
Columbus, OH jobs
The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific communication strategy for the assigned Nephrology & Immunology therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy.
The role is a key leadership position within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Executive Director, Nephrology & Immunology Business Unit Lead.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the Nephrology & Immunology portfolio aligned to the overall medical strategy (developed by the medical strategy team)
+ Collaborate with the Nephrology & Immunology BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all Nephrology & Immunology medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core Nephrology & Immunology team meetings, aligning communication plans with Nephrology & Immunology BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the Global Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
+ Consider technology and AI to support workflow improvement
+ Manage and mentor a team of medical writers and communication professionals, fostering excellence, innovation, and continuous development.
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in a Nephrology & Immunology related field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global communication strategies for late-stage assets and an emerging portfolio, preferably in Nephrology & Immunology therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus
**Skills and Competencies:**
+ Strong ability to present to executive leadership team
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
+ Knowledge of digital platforms and tools for medical content delivery and engagement
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Quality Solutions
Columbus, OH jobs
- Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams.
- The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes.
- The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights.
- The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka's Quality Knowledge and Document Management practices to a best in class - digitalized landscape.
Key job responsibilities
- Develop a roadmap to drive Knowledge Management to an automated, digitized and ever-green environment
- digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.
- Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions
- Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability.
- Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function.
- Drive a culture of Quality Innovation awareness
- Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness.
- Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations.
- Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well-defined business cases, clear value proposition, the management of applicable collaborators and identification/leveraging of applicable external expertise.
- Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time.
- Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities.
- Travel (approximately 10-25%)
Qualifications
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 years of applicable health care, technology or industry is experience strongly preferred.
- Advanced analytic skills, and general understanding of the drug development and regulatory process.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners and clinical trial personnel.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Medical Affairs - Nephrology
Boston, MA jobs
The Medical Affairs Senior Director provides medical and scientific leadership in the assigned Therapeutic Area(s) (TA). This role will work closely with a cross-functional group to ensure that scientific and medical strategies are aligned with broader corporate and key stakeholder needs and will ensure the flawless execution of Nephrology medical plans.
Key Duties and Responsibilities:
Critically interprets scientific data and determines the potential impact of new research on scientific and medical understanding of assigned products
Develops medical affairs plans, including Launch and Life Cycle Management plans
Shares country/regional insights with global teams to ensure global medical strategies and activities reflect the needs of the country/region
Provides fair and balanced medical information and education to health care professionals and payers that support the safe and effective use of Vertex drugs in the appropriate patients
Fosters patient access to Vertex drugs, by supporting the commercial organization in the preparation/review of reimbursement dossiers and presenting scientific data as required to key stake holders in the access process
Performs/oversees medical/scientific training for field medical teams, commercial, and other internal stakeholders
Contributes to the local Brand Team, representing the TA (scientific and medical expertise) and ensuring all activities address patient well-being and respect data integrity
Ensures compliance at country level with company policies, medical affairs SOPs, GCP and ICH
Assesses local promotional materials and ensures that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner
Knowledge and Skills:
Deep understanding of global medical, regulatory and commercial (including payer) environments
Excellent understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with key external stakeholders (e.g., healthcare providers, payers, advocacy bodies)
Deep understanding of market access in key countries
Experience in writing or reviewing scientific communications
Excellent written and oral communication skills to influence others internally/externally
Ability to develop relationships in a highly matrixed environment, as well as external relationships with leaders and industry experts
Track-record of ability to plan, initiate and complete projects within allotted time frames & delivering high quality successful results
Ability to engage in positive dialogue and resolve conflicts in a constructive manner
Ability to work within a multi-disciplinary and multi-cultural team on common projects and goals, at national and regional level
Education and Experience:
Terminal scientific degree (e.g., PhD or PharmD)
Typically requires 11 years of experience or the equivalent combination of education and experience
Pay Range:
$240,000 - $360,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplySenior Director, Global Commercial Strategy - CF Pipeline Lead
Boston, MA jobs
Vertex operates at the forefront of scientific innovation. It has seven approved medicines: five that treat the underlying cause of cystic fibrosis ("CF"), a life-threatening genetic disease, one that treats severe sickle cell disease ("SCD") and transfusion dependent beta thalassemia ("TDT"), and one that treats moderate-to-severe acute pain. Our clinical-stage pipeline includes programs in CF, SCD, beta thalassemia, acute and peripheral neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy and other autoimmune renal diseases and cytopenias, type 1 diabetes, muscular dystrophy, and autosomal dominant polycystic kidney disease.
General Summary:
The Senior Director, Global Commercial Strategy CF Pipeline Lead is accountable for understanding the evolving needs of the CF Community and Vertex's position within a potentially competitive market, actively contributing to defining the pipeline strategy, pipeline performance goals, and tracking performance against those goals.
Key Duties and Responsibilities:
* Develops the pipeline strategy (e.g., Next Generation 3.0 and mRNA therapies) and oversees creation of brand strategies and lifecycle activities including data generation to support differentiation and commercialization goals.
* Oversees development and implementation of strategic and tactical plans for our next generation CFTR modulators and mRNA therapies
* Identifies the commercial opportunity for further serial innovation
* Leads team through challenges related to creating external (promotional) communication materials for external use with customers
* Provides input into forecasting assumptions and evaluates ROI for activities across the pipeline
* Generates and consolidates key insights across HCPs and patient stakeholders (through market research, ad boards, etc.)
* Leads the development of brand name for Next Generation 3.0 and VX 522.
* Leads the development of strong collaborative partnerships with cross-functional team to support business goals
* May lead complex projects that are cross-functional in nature
Knowledge and Skills:
* Experience defining the strategy for pipeline products in an evolving landscape
* Ability to oversee generation of insights, and apply those insights to business problems/opportunities
* Analytical mindset, with demonstrated ability to develop strategy, make strategic recommendations, monitor performance, understand ROI and allocate resources
* Exceptional working knowledge of market forecasts and relationship of business drivers to revenue
* Exceptional working knowledge of MS Office applications, including PPT, Excel and Word
* Experience in pharmaceutical marketing, or closely related field(s) (e.g., pharmaceutical sales, ad agency, etc.)
Education and Experience:
* Bachelor's degree in marketing, business, or scientific degree
* Typically requires 12 years of experience or the equivalent combination of education and experience
Pay Range:
$225,600 - $338,400
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplySenior Director, Biostatistics (Hybrid)
Boston, MA jobs
Job Posting Description As a Sr. Director Biostatistics, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may leads to medical breakthroughs You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real-world challenges, ultimately contributing to the development of life-saving treatment and improving global well-being.
You will be responsible for leadership of a team to plan and execute strategy for this novel therapeutic space from a statistical point of view.
The Senior Director, Biostatistics will lead and perform highly scientific statistical functions in support of a company Therapeutic Area, as well as new and complex innovative issues. The Senior Director drives breakthrough results with strategic and technical contributions, while possessing an excellent knowledge of Biostatistics with a drug developer mindset. As a senior leader and people manager within the organization, they will play a crucial role in culture creation, team building, and coaching to direct reports and junior employees across the organization.
Responsibilities:
* Defines and implements the technical and strategic direction of assigned area of responsibility, guiding technological innovation and process improvements aligned to Biostatistics Functional/Departmental objectives.
* Oversees, manages, and directs multiple key projects, providing both strategic and technical expertise, and including clinical trials, observational studies, real world data (RWD) investigations, or other scientific research.
* Contributes to drug development strategy including clinical development plans and lifecycle management planning documents.
* Develops technical leadership, guides project teams to more meaningful and/or productive ends. Sets
the technical and scientific directions of the project(s).
* Oversees the delivery of KRMs, conducts senior review of protocols, CSRs, publications, and statistics related documents for regulatory interaction, and approves SAPs.
* Contributes or oversees the statistical contributions to external interactions with regulators, payers, review boards, etc.
* Key contributor to Statistical Review Forum (SRF) to enable statistical excellence and Biometrics strategic input in study design and planning.
* Authors or co-authors methodological or study-related publications and posters.
* Leads or oversees development and implementation of innovative designs and analysis methods.
* Oversees or contributes in a leading role to departmental working group efforts on various technical and operational issues.
* Oversees the performance of project team members, ensuring proper level of scientific rigor, effective team operation and cross-functional collaboration.
* May contribute to the management of the biostatistics department as a member of the departmental senior leadership team.
* Represents Biostatistics at leadership meetings and senior management reviews.
Education & Experience Required:
* Ph. D. in Statistics or Biostatistics.
* Typically requires 12 years of experience with a Ph.D. or the equivalent combination of education and experience.
* Prior people management experience required
* Previous project/process leadership experience required
* NDA/MAA experience and direct dealings with US or European regulators
* Significant expertise with SAS and R statistical software
* Demonstrated expertise in advanced/complex statistical methods used in drug development
* #LI-AR
#LI-Hybrid
Pay Range:
$226,400 - $339,600
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplySenior Director, Biostatistics (Hybrid)
Boston, MA jobs
Job Posting Description
As a Sr. Director Biostatistics, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may leads to medical breakthroughs
You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real-world challenges, ultimately contributing to the development of life-saving treatment and improving global well-being.
You will be responsible for leadership of a team to plan and execute strategy for this novel therapeutic space from a statistical point of view.
The Senior Director, Biostatistics will lead and perform highly scientific statistical functions in support of a company Therapeutic Area, as well as new and complex innovative issues. The Senior Director drives breakthrough results with strategic and technical contributions, while possessing an excellent knowledge of Biostatistics with a drug developer mindset. As a senior leader and people manager within the organization, they will play a crucial role in culture creation, team building, and coaching to direct reports and junior employees across the organization.
Responsibilities:
• Defines and implements the technical and strategic direction of assigned area of responsibility, guiding technological innovation and process improvements aligned to Biostatistics Functional/Departmental objectives.
• Oversees, manages, and directs multiple key projects, providing both strategic and technical expertise, and including clinical trials, observational studies, real world data (RWD) investigations, or other scientific research.
• Contributes to drug development strategy including clinical development plans and lifecycle management planning documents.
• Develops technical leadership, guides project teams to more meaningful and/or productive ends. Sets
the technical and scientific directions of the project(s).
• Oversees the delivery of KRMs, conducts senior review of protocols, CSRs, publications, and statistics related documents for regulatory interaction, and approves SAPs.
• Contributes or oversees the statistical contributions to external interactions with regulators, payers, review boards, etc.
• Key contributor to Statistical Review Forum (SRF) to enable statistical excellence and Biometrics strategic input in study design and planning.
• Authors or co-authors methodological or study-related publications and posters.
• Leads or oversees development and implementation of innovative designs and analysis methods.
• Oversees or contributes in a leading role to departmental working group efforts on various technical and operational issues.
• Oversees the performance of project team members, ensuring proper level of scientific rigor, effective team operation and cross-functional collaboration.
• May contribute to the management of the biostatistics department as a member of the departmental senior leadership team.
• Represents Biostatistics at leadership meetings and senior management reviews.
Education & Experience Required:
• Ph. D. in Statistics or Biostatistics.
• Typically requires 12 years of experience with a Ph.D. or the equivalent combination of education and experience.
• Prior people management experience required
• Previous project/process leadership experience required
• NDA/MAA experience and direct dealings with US or European regulators
• Significant expertise with SAS and R statistical software
• Demonstrated expertise in advanced/complex statistical methods used in drug development
, #LI-AR
#LI-Hybrid
Pay Range:
$226,400 - $339,600
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplySenior Director, Global Commercial Strategy - CF Pipeline Lead
Boston, MA jobs
Vertex operates at the forefront of scientific innovation. It has seven approved medicines: five that treat the underlying cause of cystic fibrosis (“CF”), a life-threatening genetic disease, one that treats severe sickle cell disease (“SCD”) and transfusion dependent beta thalassemia (“TDT”), and one that treats moderate-to-severe acute pain. Our clinical-stage pipeline includes programs in CF, SCD, beta thalassemia, acute and peripheral neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy and other autoimmune renal diseases and cytopenias, type 1 diabetes, muscular dystrophy, and autosomal dominant polycystic kidney disease.
General Summary:
The Senior Director, Global Commercial Strategy CF Pipeline Lead is accountable for understanding the evolving needs of the CF Community and Vertex's position within a potentially competitive market, actively contributing to defining the pipeline strategy, pipeline performance goals, and tracking performance against those goals.
Key Duties and Responsibilities:
Develops the pipeline strategy (e.g., Next Generation 3.0 and mRNA therapies) and oversees creation of brand strategies and lifecycle activities including data generation to support differentiation and commercialization goals.
Oversees development and implementation of strategic and tactical plans for our next generation CFTR modulators and mRNA therapies
Identifies the commercial opportunity for further serial innovation
Leads team through challenges related to creating external (promotional) communication materials for external use with customers
Provides input into forecasting assumptions and evaluates ROI for activities across the pipeline
Generates and consolidates key insights across HCPs and patient stakeholders (through market research, ad boards, etc.)
Leads the development of brand name for Next Generation 3.0 and VX 522.
Leads the development of strong collaborative partnerships with cross-functional team to support business goals
May lead complex projects that are cross-functional in nature
Knowledge and Skills:
Experience defining the strategy for pipeline products in an evolving landscape
Ability to oversee generation of insights, and apply those insights to business problems/opportunities
Analytical mindset, with demonstrated ability to develop strategy, make strategic recommendations, monitor performance, understand ROI and allocate resources
Exceptional working knowledge of market forecasts and relationship of business drivers to revenue
Exceptional working knowledge of MS Office applications, including PPT, Excel and Word
Experience in pharmaceutical marketing, or closely related field(s) (e.g., pharmaceutical sales, ad agency, etc.)
Education and Experience:
Bachelor's degree in marketing, business, or scientific degree
Typically requires 12 years of experience or the equivalent combination of education and experience
Pay Range:
$225,600 - $338,400
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyDirector, Financial Planning & Analysis, Corporate Finance
Boston, MA jobs
The Director of Corporate Finance is a key member within the Finance organization, responsible for driving short term global planning, forecasting, and reporting processes-including budget development, consolidated performance reporting, and preparation of Board materials. This role partners closely with Finance leadership and cross‑functional stakeholders to provide financial direction and deliver strategic insights that enable achievement of Vertex objectives. The Director leads and develops a team of FP&A professionals, ensuring the delivery of accurate, timely, and actionable financial information that supports executive decision‑making and strengthens shareholder communication. Success in this role requires exceptional communication skills, the ability to distill complex financial data into clear narratives, and the influence to guide decisions across a matrixed organization.
Key Responsibilities
Team Leadership
* Defines and drives the vision for Corporate Finance, aligning planning and reporting processes with Vertex's long-term strategic objectives. Influences enterprise decision-making through actionable insights and thought leadership.
* Builds organizational capability by developing future leaders, fostering an inclusive and high-performance culture, and mentoring talent across Finance.
Planning & Forecasting
* Lead preparation and consolidation of annual budgets, quarterly forecasts, and monthly reporting.
* Partner with functional finance teams to align assumptions, ensure accuracy, and support scenario planning and sensitivity analyses.
Performance Management & Reporting
* Deliver insightful reporting packages and financial analysis for senior management, Executive Committee, and Board presentations.
* Monitor KPIs and performance metrics to track progress against corporate and functional goals.
Process Optimization & Systems
* Leads transformational initiatives to enhance financial planning and analytics processes and capabilities, leveraging technology and innovation to position Vertex for sustainable growth.
* Partner with Financial Systems teams to optimize use of Hyperion/BI systems and other tools.
Cross‑Functional Collaboration
* Collaborate with R&D, Commercial, and Operations finance teams to provide financial guidance for strategic initiatives.
* Work closely with Investor Relations, HR, Tax, Treasury, and Accounting to reflect enterprise planning and process optimization.
* Lead Corporate Finance SOX processes, partnering closely with Accounting and Internal Audit teams to ensure process controls are maintained and evidenced
Required Education Level
* Bachelors degree in Finance, Accounting or an equivalent qualification
* MBA, CFA or CPA strongly preferred
Required Experience
* 12+ years of progressive financial management experience, with a heavy emphasis on financial planning and analysis with proven ability to manage complex financial processes
* Proven experience operating effectively within a large, complex, and highly regulated global pharmaceutical or biotechnology company.
Required Knowledge/Skills
* Strong analytical and financial skills to evaluate a broad range of financial questions-especially portfolio analysis, valuation, ROI/ROIC, and complex business questions.
* Strong skills demonstrated in MS Office and financial software applications, including Hyperion.
* Strong communication, influencing and interpersonal skills necessary for daily interaction with senior management, as well as business partners and peers within Finance.
* Demonstrated experience building/developing/leading a high performing team.
* Detail-oriented with ability to synthesize big picture story
* Ability to lead and drive change in a developing business environment, coordinating processes involving large numbers of people, complex systems, and tight deadlines across multiple time zones.
* "Internal consultant mindset" with ability to solve problems through pragmatic, creative approaches
* Capability to pro-actively participate in managing within a cross-cultural matrix organization and develop a high performing group of business partners.
* Capacity to understand the pharmaceutical industry to address a broad range of challenges and business issues globally across all functions with the ability to make and facilitate quick decisions.
* Flexibility and willingness to take on new responsibilities and assist with various ad-hoc projects as needed
Pay Range:
$182,400 - $273,600
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyDirector, Accounting Systems & Consolidation (Hybrid)
Boston, MA jobs
Vertex is seeking a hands-on, experienced consolidations leader with accounting systems and process expertise to join our Global Accounting organization. The Director, Accounting Systems & Consolidation will oversee the global close and consolidation process and drive accounting system and financial reporting excellence. In addition, the Director will closely partner with IT and other stakeholders to maintain and enhance our key accounting systems and applications such as HFM, Oracle EBS, and Blackline. This newly established role is ideal for a motivated leader who can effectively lead our small team of experienced professionals to align diverse stakeholders, foster collaboration, and deliver innovative solutions to advance our consolidation processes and accounting systems.
Key Duties and Responsibilities:
* Drive process excellence for the monthly, quarterly, and yearly close and consolidation process, working closely with the appropriate stakeholders (global accounting, tax, treasury, finance and shared services) to ensure timely and accurate financial results
* Develop and execute strategy for various consolidation initiatives, such as intercompany automation, cloud-based applications, and RPA bots
* Partnering with Vertex's IT organization, maintain and support our key accounting systems and applications such as HFM, Oracle EBS, and Blackline, including change management for upgrades and enhancements
* Collaborate with global partners to formulate enhancement options to address specific functional issues/requirements
* Manage and oversee completeness and accuracy of system eliminations for intercompany balance sheet and income statement activity
* Develop and monitor metrics and key performance indicators that drive best practices
* Assist in the development of the overall Accounting Systems roadmap
* Effectively lead team of 4 experienced professionals; mentor, develop, retain and recruit high potential talent
Knowledge and Skills:
* Expertise with complex integrated financial reporting systems, inclusive of HFM, Hyperion ESSbase and Oracle EBS
* Knowledge of financial consolidation, accounting for intercompany and foreign currency translations, eliminations, reporting for monthly and quarterly closes, general ledgers, hierarchies and data structures
* Direct management of governance and finance system compliance in accordance with company policies, standards and SOX requirements
* Strong systems mindset and understanding of accounting system workflows
* Applies knowledge and understanding of financial and US GAAP accounting principles to systems and business processes
* Ability to interact and partner with all levels of management to help drive collaborative business decisions
* Possesses interpersonal and organizational skills, high energy level and strong work ethic
* Able to anticipate change and respond to client priorities, demonstrating a "can do" attitude
* Excellent written and verbal communication skills including the ability to succinctly convey relevant information across multiple levels of the organization
* Finance process excellence or Six-Sigma experience a significant plus
Education and Experience:
* Bachelor's degree in either Accounting, Finance, Information Technology, Business or a related field
* Typically requires 10+ years of experience in finance or accounting with a large, complex, multinational organization
* Big 4 experience and life science industry experience is preferred
* CPA or equivalent certifications are desirable
* A track record of success working in a team-based environment
Pay Range:
$173,600 - $260,300
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyDirector, Accounting Systems & Consolidation (Hybrid)
Boston, MA jobs
Vertex is seeking a hands-on, experienced consolidations leader with accounting systems and process expertise to join our Global Accounting organization. The Director, Accounting Systems & Consolidation will oversee the global close and consolidation process and drive accounting system and financial reporting excellence. In addition, the Director will closely partner with IT and other stakeholders to maintain and enhance our key accounting systems and applications such as HFM, Oracle EBS, and Blackline. This newly established role is ideal for a motivated leader who can effectively lead our small team of experienced professionals to align diverse stakeholders, foster collaboration, and deliver innovative solutions to advance our consolidation processes and accounting systems.
Key Duties and Responsibilities:
Drive process excellence for the monthly, quarterly, and yearly close and consolidation process, working closely with the appropriate stakeholders (global accounting, tax, treasury, finance and shared services) to ensure timely and accurate financial results
Develop and execute strategy for various consolidation initiatives, such as intercompany automation, cloud-based applications, and RPA bots
Partnering with Vertex's IT organization, maintain and support our key accounting systems and applications such as HFM, Oracle EBS, and Blackline, including change management for upgrades and enhancements
Collaborate with global partners to formulate enhancement options to address specific functional issues/requirements
Manage and oversee completeness and accuracy of system eliminations for intercompany balance sheet and income statement activity
Develop and monitor metrics and key performance indicators that drive best practices
Assist in the development of the overall Accounting Systems roadmap
Effectively lead team of 4 experienced professionals; mentor, develop, retain and recruit high potential talent
Knowledge and Skills:
Expertise with complex integrated financial reporting systems, inclusive of HFM, Hyperion ESSbase and Oracle EBS
Knowledge of financial consolidation, accounting for intercompany and foreign currency translations, eliminations, reporting for monthly and quarterly closes, general ledgers, hierarchies and data structures
Direct management of governance and finance system compliance in accordance with company policies, standards and SOX requirements
Strong systems mindset and understanding of accounting system workflows
Applies knowledge and understanding of financial and US GAAP accounting principles to systems and business processes
Ability to interact and partner with all levels of management to help drive collaborative business decisions
Possesses interpersonal and organizational skills, high energy level and strong work ethic
Able to anticipate change and respond to client priorities, demonstrating a “can do” attitude
Excellent written and verbal communication skills including the ability to succinctly convey relevant information across multiple levels of the organization
Finance process excellence or Six-Sigma experience a significant plus
Education and Experience:
Bachelor's degree in either Accounting, Finance, Information Technology, Business or a related field
Typically requires 10+ years of experience in finance or accounting with a large, complex, multinational organization
Big 4 experience and life science industry experience is preferred
CPA or equivalent certifications are desirable
A track record of success working in a team-based environment
Pay Range:
$173,600 - $260,300
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-Apply