Senior Director Medical Affairs, Movement Disorders
Associate director job at Lundbeck
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, Client Service
New York, NY jobs
We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. To start a career that is out of the ordinary, please apply...Job Details
Job Title: Senior Director, Client Service, Media
Job Location: Hybrid- Atlanta, Boston, Chicago, New York City, Norwalk
About the role
The Senior Director role is a strategic leadership position responsible for overseeing a portfolio of high-value accounts and guiding strategic account teams. This individual acts as a senior advisor to executive-level stakeholders, influencing investment decisions and driving multi-year growth plans. The role combines deep expertise in media research and analytics with executive engagement and commercial accountability.
Primary Responsibilities
Oversee a portfolio of high-value accounts; manage and lead small portfolio teams or strategic account teams to deliver exceptional client outcomes.
Serve as a senior advisor to executive-level stakeholders; influence strategic investment decisions through evidence-based insights.
Accountable for retention of portfolio and responsible for multi-year growth plans, cross-sell strategies, and achievement of significant revenue targets.
Lead executive-level research initiatives; synthesize primary, secondary, and advanced analytics into actionable narratives for senior decision-making.
Optimize resource allocation and deliver operational efficiency across portfolio teams; shape best practices for quality delivery at scale.
Represent Kantar in industry forums and enterprise-wide initiatives; champion innovation in media analytics and cross-platform measurement.
Develop and nurture high-performing teams by identifying, mentoring, and advancing top talent through a culture of continuous learning and collaboration.
Essential Knowledge & Experience
7+ years in media research, analytics, or consulting with proven success in executive-level engagement.
Expertise in digital ecosystems, cross-platform measurement methodologies, creative quality, and/or placement and audience insights.
Strong command of advanced research techniques, including attribution, ROI modeling, and audience segmentation.
Advanced ability to synthesize complex data into compelling narratives for executive audiences.
Proven ability to shape strategic investment decisions and drive commercial outcomes.
Track record of delivering multi-year growth plans and achieving significant revenue targets for an account portfolio.
Demonstrated success in managing senior client relationships and leading high-performing teams, including direct management of a team of 3 or more professionals.
Ability to navigate fast-paced agency or complex client environments, balancing strategic depth with delivery efficiency.
Bachelor's degree in market research/marketing or related social science and analytic subject areas. Masters preferred
Location
New York, World Trade CenterUnited States of America
Kantar Rewards Statement
At Kantar we have an integrated way of rewarding our people based around a simple, clear and consistent set of principles. Our approach helps to ensure we are market competitive and also to support a pay for performance culture, where your reward and career progression opportunities are linked to what you deliver.
We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. Apply for a career that's out of the ordinary and join us.
We want to create an equality of opportunity in a fair and supportive working environment where people feel included, accepted and are allowed to flourish in a space where their mental health and well being is taken into consideration.
We want to create a more diverse community to expand our talent pool, be locally representative, drive diversity of thinking and better commercial outcomes.
Kantar is the world's leading data, insights and consulting company. We understand more about how people think, feel, shop, share, vote and view than anyone else. Combining our expertise in human understanding with advanced technologies, Kantar's 30,000 people help the world's leading organisations succeed and grow.
Auto-ApplyDirector, Epidemiology
King of Prussia, PA jobs
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three days onsite.
Responsibilities:
• As the epidemiology lead for designated products proactively define epidemiology research strategies to contribute to R&D and Commercial objectives.
• Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports.
• Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests).
• Lead structured benefit-risk assessments, using qualitative and quantitative methods.
• Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company.
• Assist the head of department to facilitate ongoing development and growth of the department.
• Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc.
Qualifications:
• Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master's degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry.
• Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products. Ability to proactively advise and lead product teams in this regard.
• Sustained autonomous performance as epidemiology lead to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity.
• Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting.
• Demonstrated experience leading organizational process improvement or change management initiatives.
• Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities.
#LI-HYBRID
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
Auto-ApplySenior Director, Project Mgt Office
King of Prussia, PA jobs
Lead the Project Management Office for R&D
Main Responsibilities & Accountabilities
••Leads PM office which will elevate the craft of all Project Managers in RD by steadily training the best personal practices, tools and methods to an end-to-end community of PM•Challenges the broader organization to be more project centric through outside in thinking, proposing process/culture/governance changes as part of the PPE group.•Provides direct management oversight of PMO group, China PM team (2), Submission PM (4 FTE + FSP) and dotted line reporting for Japan PM (4 FTE); through this ensures that all projects get consistent specialty support from these groups, and that their practices and resources meet the needs of the R&D portfolio.•Provides and trains R&D Project Managers in fit for purpose Tools, Templates and PM learning function that enable RD& projects to be planned in a consistent manner, that meets the needs of the organization for risk management, budget, critical path / timelines and resourcing issues.
Qualifications & Experience
Requirements
•12+ years in R&D project Management or operations•Expert, first-hand knowledge of PM best practices, tools, templates and training groups on these•Experience working in cross-functional R&D teams•In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals•An advanced degree in Science, Master of Business Administration (MBA), PMP certification, or equivalent is a plus.•Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.•Involvement in cross-functional, multicultural and international teams preferable.•Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences•Excellent Strategic Thinking skills•Significant experience in the application and utilization of portfolio management systems and software••About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
Auto-ApplyDirector, Clinical Operations
San Francisco, CA jobs
San Francisco, CA - Hybrid
$200,000 - $250,000
Director, Clinical Operations - Emerging Metabolic Biotech
Join an early-stage biotech on a mission to transform metabolic disease treatment. Our client is building a first-in-class metabolic pipeline and seeking a Director of Clinical Operations to lead the execution of thier initial clinical programs.
What You'll Do
Own end-to-end clinical operations strategy and delivery for early-phase trials.
Select and manage CROs, vendors, and sites to ensure quality and timelines.
Drive inspection readiness and compliance across global studies.
Partner cross-functionally with Clinical Development, Regulatory, and CMC teams to shape program strategy.
What We're Looking For
10+ years in clinical operations with proven leadership in early-phase studies.
Experience in metabolic or related therapeutic areas strongly preferred.
Ability to thrive in a fast-paced, resource-conscious environment.
Hands-on approach with strategic vision-comfortable building processes from the ground up.
This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
Director/Senior Director, Analytical Development
New York, NY jobs
Head of Analytical Development: NYC
We are seeking a Director or Senior Director of Analytical Development to lead and expand the analytical development function. This individual will play a pivotal role in supporting late-stage programs, ensuring robust analytical strategies for drug substance and drug product, and driving method development, validation, and transfer activities.
This is a hands-on leadership role for someone who thrives in a dynamic environment, enjoys rolling up their sleeves, and is committed to building best-in-class analytical capabilities. The ideal candidate will be comfortable commuting to the New York site four days per week and collaborating cross-functionally with CMC, Quality, and external partners.
Key Responsibilities
Lead the Analytical Development team responsible for method development, qualification, validation, and transfer for drug substance and drug product.
Develop and implement analytical strategies to support late-stage development, scale-up, and commercialization.
Oversee characterization studies, stability programs, and specification setting in alignment with regulatory requirements.
Partner closely with Process Development, Quality, and Regulatory teams to ensure seamless integration of analytical deliverables.
Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met.
Provide technical leadership and mentorship to a growing team, fostering a culture of scientific excellence and accountability.
Contribute to regulatory submissions (IND, NDA) and represent Analytical Development in health authority interactions as needed.
Qualifications
Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
10+ years of experience in analytical development within the biotech or pharmaceutical industry, with a strong focus on small molecule late-stage development and commercialization.
Proven track record of leadership in method development, validation, and transfer for complex modalities (biologics experience strongly preferred).
Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for global filings.
Excellent communication and collaboration skills; ability to work effectively in a fast-paced, matrixed environment.
Willingness and ability to be onsite in New York 4 days per week.
Why Join?
Opportunity to shape analytical strategy for a late-stage pipeline with high-impact programs.
Work in a well-funded biotech with strong pharma partnerships and a clear path to commercialization.
Collaborative, science-driven culture where your contributions make a tangible difference.
DIRECT HIRE - Mitsubishi Tanabe Pharma America - Senior Director, Trade & Distribution
Jersey City, NJ jobs
EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan's most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson's (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.
MTPA is rapidly expanding its operations across all functional areas. MTPA's commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA (edaravone) injectables in 2017 and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.
Job Description
Direct Hire Opportunity!
The Senior Director, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the Senior Director Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role.
Responsibilities
Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US' lead Parkinson and ALS products
Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing
trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject
matter expert from a Market Access perspective for 340B program and other government programs.
Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US
Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies
Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process
Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function
Effectively manages budgets and project timelines including contract management
Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate
Develop account metrics against strategic, financial, and product access KPI's
Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders
Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business.
This is a home office based position. The expectation is to be in the office 3 days a week.
Qualifications
Bachelor's Degree Required, Masters preferred
Must have 15 plus years within the pharmaceutical industry and 10 years' experience in Distribution, Account Management or Aligned Market Access functions.
Experience with distribution for early-stage pipeline programs
Experience in Federal Markets including VA, Department of Defense and 340B Program preferred.
Device/Drug combination strongly preferred
Minimum 5 years of people management experience required
Track record of closing complex negotiations within the specialty pharmacy arena
Preferred experience includes:
All aspects of distribution
Launch and life cycle management for the distribution process
Experience in Market Access marketing
History of successful negotiations
Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions
Firm grasp of legal, regulatory and compliance issues in the healthcare space
Analytical/strategic thinker with proven ability to:
conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans
understand the best pathway for distribution based on the product and its attributes
conduct strategic gap analysis and implement metric-based solutions
Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment
Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences
Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget
Highly proficient in MS Office; advanced Excel skills
Must be able to travel domestically and internationally (approximately 40%)
Additional Information
Mitsubishi Tanabe Pharma America Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.
MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.
Director GHEOR
Philadelphia, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Director GHEOR
Conshohocken, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Executive Director, Corporate Legal Counsel
San Diego, CA jobs
Executive Director, Corporate Legal Counsel page is loaded## Executive Director, Corporate Legal Counselremote type: Hybrid-San Diegolocations: San Diego, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR000519**Salary Range**The salary range for this position is: $281,000 - $351,000.*In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*
#J-18808-Ljbffr
Associate Director, Clinical Science
Saltaire, NY jobs
Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed.
The Impact You'll Make
Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a Director level Clinical Scientist who can oversee all clinical aspects of a clinical trial(s). This would include: planning and authoring of clinical deliverables (protocols, amendments, medical monitoring plans, annual reports, study-specific updates, CSRs), routine medical monitoring, site interaction / correspondence re: patient eligibility and treatment inquiries, and presentations both internal and external. As an Associate Director within Clinical Science, you'll play a critical role ensuring study protocols are executed appropriately and that the study data is both appropriate and pristine. On a daily basis, you will interact cross-functionally with multiple disciplines supporting the Study Team (Clinical Operations, Medical Director, CMC, Data Management, CROs, CRAs, Investigative Sites, etc). You'll be responsible for reviewing and cleaning / querying pertinent data points, identifying trends or inconsistencies with the data, and serving as the face of the study to Investigative Sites. You can expect to work on multiple early-phase projects at the same time in a fast-paced and exciting environment where the ability to multi-task and rapidly re-organize thoughts and priorities will be essential.
In this role, you will:
Create - Serve as the authoring lead on multiple clinical documents. Recursion is moving away from the use of Medical Writers and relying more heavily on the Clinical Scientist and Medical Director to author IND and study specific documents. While this will not refer to manuals it does encompass Clinical documents and site / agency interactions.
Collaborate - Work with highly dynamic teams where your role will range from leading and owning decisions or timelines to being a key contributor whose experience and insight are relied upon to advance the task at hand.
Drive & Deliver - You will be primarily responsible for the quality of your study data. This will include reviewing (Medical Monitoring); issuing, reviewing, and closing queries; reviewing TLFs, summarizing data throughout the trial, and presenting the data to management when requested. You will also be required to present the protocol procedures and Site Initiation Visits both in-person and virtually.
Prioritize - Given the nature of Recursion, you will be required to support multiple early phase (1-2) studies simultaneously. This will require time management and organizational skills.
The Team You'll Join
Reporting to the Vice President, Clinical Science, you'll be joining the Clinical Science Team within Clinical Development. This group is ultimately responsible for shepherding an experimental drug from IND through Dose Finding, Proof of Concept, and possibly Registration studies. Clinical Science consists of a high performing Team of extremely motivated individuals who work independently, interact cross-functionally with many contributing departments, and are capable of multi-tasking to expeditiously execute cutting edge clinical trials.
The Experience You'll Need
5+ years as a Clinical Scientist in a pharmaceutical or biotech company
Prior experience in early phase 1-2 oncology studies is required.
Experience with hematologic malignancies is preferred.
Strong interpersonal and communication skills (both spoken and written) - with ability to effectively communicate on project planning, progress, tracking etc.
Strong relationship building skills to work effectively with others in various disciplines and levels
Proven ability to manage multiple, complex, and competing priorities to effective and efficient conclusion
Ability to operate strategically and tactically
Proven ability in problem solving and issues management that is solution focused
Working Location:
This is an office-based, hybrid role in our Salt Lake City / New York City office. Employees are expected to work in the office at least 50% of the time.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $180,600 - $229,000 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyAssociate Director of Clinical Data Management
New York jobs
Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed.
The Impact You'll Make
Recursion is seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. You'll also play a critical role in the management of all the 3rd party data sources and serve as SME for Data Management. You'll be responsible for leading and delivering initiatives for CDM within the Biometrics group. You'll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CRO's, timelines and project risk management. You can expect to work on multiple projects at the same time in a fast-paced and exciting environment.
In this role, you will:
Lead End to End Data Management activities with hands on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously.
Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables.
Works with CRO and Recursion functional groups to complete EDC set up, database migrations /UAT and other systems such as IRT, ePRO etc. Manage multiple vendor sFTPs for data retrieval and delivery to stat programming, routinely.
Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight. . Aim to harmonize processes where relevant with other Recursion clinical programs.
Serve as a SME for various operational activities and DM processes like EDC, External data standardization, Collection, and Processing. Lead the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRF's Data Review Plans etc. Routinely provide study metrics, planning of deliverables, and propose solutions for data handling/related issues.
Lead/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG's, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans.
Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
Strategic and critical thinker who can independently lead initiatives and effectively collaborate cross functionally.
Accountable for coordination with other functional groups for submission related activities.
Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks.
Ensure filing, archival and inspection readiness of all Data Management Trial Master File (TMF) activities.
Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting.
Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions.
Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.
The Team You'll Join
Reporting to Senior Director, Clinical Data Management and working closely with Biometrics, Clinical Operations and Clinical development Organization, you will be an essential member of the Recursion Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities.
The Experience You'll Need
Bachelor's degree in science, math or computer science
12+ years' experience in the biopharmaceutical industry. Experience, technical proficiency and People management skills will determine the level.
Experience managing external data and 3rd party vendors is a must.
Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
Excellent written and verbal communication skills and ability to work collaboratively as a part of a team.
Working Location & Compensation:
This position can be based at any of our offices in Salt Lake City or New York City. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office. Relocation support can be provided for this role. At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:
$189,000 - $232,000 USD for candidates based in the United States
You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyAssociate Director, Clinical Science
New York, NY jobs
Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a Director level Clinical Scientist who can oversee all clinical aspects of a clinical trial(s). This would include: planning and authoring of clinical deliverables (protocols, amendments, medical monitoring plans, annual reports, study-specific updates, CSRs), routine medical monitoring, site interaction / correspondence re: patient eligibility and treatment inquiries, and presentations both internal and external. As an Associate Director within Clinical Science, you'll play a critical role ensuring study protocols are executed appropriately and that the study data is both appropriate and pristine. On a daily basis, you will interact cross-functionally with multiple disciplines supporting the Study Team (Clinical Operations, Medical Director, CMC, Data Management, CROs, CRAs, Investigative Sites, etc). You'll be responsible for reviewing and cleaning / querying pertinent data points, identifying trends or inconsistencies with the data, and serving as the face of the study to Investigative Sites. You can expect to work on multiple early-phase projects at the same time in a fast-paced and exciting environment where the ability to multi-task and rapidly re-organize thoughts and priorities will be essential.
In this role, you will:
* Create - Serve as the authoring lead on multiple clinical documents. Recursion is moving away from the use of Medical Writers and relying more heavily on the Clinical Scientist and Medical Director to author IND and study specific documents. While this will not refer to manuals it does encompass Clinical documents and site / agency interactions.
* Collaborate - Work with highly dynamic teams where your role will range from leading and owning decisions or timelines to being a key contributor whose experience and insight are relied upon to advance the task at hand.
* Drive & Deliver - You will be primarily responsible for the quality of your study data. This will include reviewing (Medical Monitoring); issuing, reviewing, and closing queries; reviewing TLFs, summarizing data throughout the trial, and presenting the data to management when requested. You will also be required to present the protocol procedures and Site Initiation Visits both in-person and virtually.
* Prioritize - Given the nature of Recursion, you will be required to support multiple early phase (1-2) studies simultaneously. This will require time management and organizational skills.
The Team You'll Join
Reporting to the Vice President, Clinical Science, you'll be joining the Clinical Science Team within Clinical Development. This group is ultimately responsible for shepherding an experimental drug from IND through Dose Finding, Proof of Concept, and possibly Registration studies. Clinical Science consists of a high performing Team of extremely motivated individuals who work independently, interact cross-functionally with many contributing departments, and are capable of multi-tasking to expeditiously execute cutting edge clinical trials.
The Experience You'll Need
* 5+ years as a Clinical Scientist in a pharmaceutical or biotech company
* Prior experience in early phase 1-2 oncology studies is required.
* Experience with hematologic malignancies is preferred.
* Strong interpersonal and communication skills (both spoken and written) - with ability to effectively communicate on project planning, progress, tracking etc.
* Strong relationship building skills to work effectively with others in various disciplines and levels
* Proven ability to manage multiple, complex, and competing priorities to effective and efficient conclusion
* Ability to operate strategically and tactically
* Proven ability in problem solving and issues management that is solution focused
Working Location:
This is an office-based, hybrid role in our Salt Lake City / New York City office. Employees are expected to work in the office at least 50% of the time.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $180,600 - $229,000 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
* We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
* We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
* We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
* We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
* We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
* We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyAssociate Director of Clinical Data Management
New York, NY jobs
Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed. The Impact You'll Make Recursion is seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. You'll also play a critical role in the management of all the 3rd party data sources and serve as SME for Data Management. You'll be responsible for leading and delivering initiatives for CDM within the Biometrics group. You'll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CRO's, timelines and project risk management. You can expect to work on multiple projects at the same time in a fast-paced and exciting environment.
In this role, you will:
* Lead End to End Data Management activities with hands on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously.
* Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables.
* Works with CRO and Recursion functional groups to complete EDC set up, database migrations /UAT and other systems such as IRT, ePRO etc. Manage multiple vendor sFTPs for data retrieval and delivery to stat programming, routinely.
* Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight. . Aim to harmonize processes where relevant with other Recursion clinical programs.
* Serve as a SME for various operational activities and DM processes like EDC, External data standardization, Collection, and Processing. Lead the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRF's Data Review Plans etc. Routinely provide study metrics, planning of deliverables, and propose solutions for data handling/related issues.
* Lead/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG's, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans.
* Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
* Strategic and critical thinker who can independently lead initiatives and effectively collaborate cross functionally.
* Accountable for coordination with other functional groups for submission related activities.
* Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks.
* Ensure filing, archival and inspection readiness of all Data Management Trial Master File (TMF) activities.
* Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting.
* Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions.
* Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.
The Team You'll Join
Reporting to Senior Director, Clinical Data Management and working closely with Biometrics, Clinical Operations and Clinical development Organization, you will be an essential member of the Recursion Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities.
The Experience You'll Need
* Bachelor's degree in science, math or computer science
* 12+ years' experience in the biopharmaceutical industry. Experience, technical proficiency and People management skills will determine the level.
* Experience managing external data and 3rd party vendors is a must.
* Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
* Excellent written and verbal communication skills and ability to work collaboratively as a part of a team.
Working Location & Compensation:
This position can be based at any of our offices in Salt Lake City or New York City. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office. Relocation support can be provided for this role. At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:
* $189,000 - $232,000 USD for candidates based in the United States
You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
* We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
* We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
* We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
* We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
* We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
* We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyAssociate Director, Regulatory Operations and Intelligence
Saltaire, NY jobs
Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed.
The Impact You'll Make
We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs.
Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary.
Format and publish regulatory documents at the document level in accordance with health authority requirements and the appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post-publishing.
Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies.
Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. The interactive on-going trackers should be updated regularly.
Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.)
Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution.
Stay updated on local and global regulatory submission requirements and implement new publishing requirements.
Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents.
The Team You'll Join
Reporting to the Vice President, Regulatory, you'll be an integral part of the regulatory team leading regulatory operations and intelligence function. On the diverse team, you'll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion's regulatory strategy along with leading the intelligence function to disseminate impact from regulatory changes across different regions.
The Experience You'll Need
Master's or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
7+ years of industry-related experience in a regulatory publishing function.
5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo).
Experience with setting up regulatory intelligence functions and tools is a must.
Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus.
Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers.
Experience interacting with health authorities for operational systems is preferred.
Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus.
Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust.
Critical thinker with excellent attention to detail.
Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
Experience in project management is a plus.
Working Location & Compensation:
This is an office-based, hybrid role in our Salt Lake City / New York City office. Employees are expected to work in the office at least 50% of the time.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $175,400 - $206,400 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyAssociate Director, Regulatory Operations and Intelligence
New York, NY jobs
Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed. The Impact You'll Make We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs.
* Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary.
* Format and publish regulatory documents at the document level in accordance with health authority requirements and the appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post-publishing.
* Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies.
* Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. The interactive on-going trackers should be updated regularly.
* Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.)
* Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution.
* Stay updated on local and global regulatory submission requirements and implement new publishing requirements.
* Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents.
The Team You'll Join
Reporting to the Vice President, Regulatory, you'll be an integral part of the regulatory team leading regulatory operations and intelligence function. On the diverse team, you'll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion's regulatory strategy along with leading the intelligence function to disseminate impact from regulatory changes across different regions.
The Experience You'll Need
* Master's or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
* 7+ years of industry-related experience in a regulatory publishing function.
* 5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo).
* Experience with setting up regulatory intelligence functions and tools is a must.
* Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus.
* Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers.
* Experience interacting with health authorities for operational systems is preferred.
* Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus.
* Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust.
* Critical thinker with excellent attention to detail.
* Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
* Experience in project management is a plus.
Working Location & Compensation:
This is an office-based, hybrid role in our Salt Lake City / New York City office. Employees are expected to work in the office at least 50% of the time.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $175,400 - $206,400 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
* We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
* We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
* We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
* We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
* We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
* We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyAssociate Director, Market Access Marketing, Sleep
Palo Alto, CA jobs
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit****************************** more information.
The Associate Director (AD), Market Access Marketing - Sleep will support the Sleep Franchise team with a remit of optimally positioning Jazz products to enable patient access in an increasingly challenging and evolving US access landscape.
The AD, Market Access Marketing - Sleep will report to and primarily function as strategic support to the Director, Market Access Marketing - Sleep and lead the tactical execution in support of brand strategy. The AD is responsible for the implementation of the payer value proposition and promotional/non-personal tools and tactics for use with third party payers. In addition, this individual will work cross-functionally with various field teams including Payer Account teams, Field Access and Reimbursement teams, and Field Sales teams to ensure they are equipped with programs, tools, resources, and messaging to optimize customer engagement and ensure patient access.
Key Responsibilities
Strategic Thinking: Think strategically across indications to identify opportunities to align and further complement efforts to maximize value communication
Brand Plan Execution: Work with the marketing team and other stakeholder functions to execute and refine brand tactical plan with the goal of driving both awareness and perception of access among target audiences; participate in the development and execution of the annual brand planning process. Build, coordinate, and orchestrate a cross-functional view of full market access activities and activations
Value Communication: Craft compelling payer value propositions, messaging platforms, and tools that resonate with key stakeholders including payers, providers, healthcare decision-makers
Resource Development: Create innovative tools and materials (e.g., pull through materials, resource guides, AMCP dossiers, value decks, field training modules) to support field teams in effectively communicating product value and outcomes
Cross-Functional Collaboration: Partner with Market Access, HEOR, Medical Affairs, Regulatory, Compliance, Brand Marketing, and Sales teams to align access strategies and ensure consistent execution
Insight Generation: Conduct primary and secondary research, analyze relevant data, and monitor competitive and market trends to generate meaningful payer/HCP insights for use in business decision-making
Performance Measurement: Lead the development and coordination of performance measurement and reporting across responsible assets and KPIs to ensure access messaging is effectively delivering on brand access objectives
Qualifications
Bachelor's degree required; advanced degree (MBA, MPH, PharmD) preferred
7+ years of combined experience in pharmaceutical marketing, market access, or related field
4+ years of experience in Market Access Marketing, Patient Support Services, and/or Payer Account Management
Deep understanding of the U.S. healthcare landscape, including payer dynamics and reimbursement pathways
Thorough understanding of processes to develop and obtain approval of promotional materials, including navigating Medical, Regulatory, and legal reviews
Strong communication, analytical, and project management skills
Ability to thrive in a fast-paced, matrixed environment
Pharmaceutical career progression that demonstrates growth in responsibility and scope, particularly in commercial Market Access positions
The position will be primarily home based, with the expectation that the person is willing to travel to meetings as necessary
Preferred
Specialty pharmaceutical Market Access related experience
Specialty/retail pharmaceutical Marketing related experience
#LI-Remote
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $162,400.00 - $243,600.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: *********************************************
RequiredPreferredJob Industries
Other
Senior Director Medical Affairs, Movement Disorders
Associate director job at Lundbeck
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.
Associate Director, DEA Compliance
Homestead, IA jobs
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview Position is responsible for ensuring that Cambrex Charles City, Inc.
(CCC) is compliant with Drug Enforcement Administration (DEA) regulations and requirements.
This individual monitors day-to-day operations related to controlled substances (CS) and manages the overall site CS program.
This individual will interact with regulators and customers on CS related matters, and represent the company during third party audits and inspections.
Responsibilities Responsible for monitoring and maintaining compliance with DEA regulations pertaining to shipping, manufacturing, analytical and research activities associated with controlled substances and listed chemicals.
Maintain all related registrations with DEA and other agencies as needed.
Maintain State licensure program.
Complete associated reporting requirements.
Complete and file ARCOS quarterly and year end reports.
Maintain CS and listed chemical files including those pertaining to shipping, receiving, 222 forms, ARCOS reports and correspondence with the DEA or appropriate State agencies.
Interface with DEA as needed, including written, oral and face to face interactions.
Maintain records and correspondence relating to the destruction of CS.
Maintain complete and accurate records pertaining to CS related operations and lab handling.
Complete, reconcile and report all CS and listed chemical inventories.
Assist all departments with CS related issues.
Prepare and conduct employee training on DEA requirements and related site SOP's as needed.
Author and maintain site SOP's and policies relating to CS operations and handling.
Work with Sales/Marketing and customers to obtain appropriate volume requests for CS quota.
Liaise with customers and represent the site during audits and inspections related to CS handling.
Participate on project teams for new project onboarding; liaise with DEA as needed to facilitate CS-related issues such as registration updates, quota needs, controlled status determinations, etc.
Oversee shipment of CS, including import, export and management of suspicious order monitoring program.
Oversee security programs related to CS handling and mfg.
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
All employees are expected to report to work regularly and promptly.
Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications/Skills Sound written and oral communication skills.
Experience in communication with government agencies.
Training experience beneficial.
Strong working knowledge of a computer applications within a Windows-based environment required.
Education, Experience & Licensing Requirements 4 year degree, preferably in Chemistry, Biochemistry, Biology or Engineering.
5 or more years of experience in administering controlled substances or products with strict regulatory guidelines.
Strong working knowledge of DEA regulatory requirements highly beneficial.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
#LI-RD14 year degree, preferably in Chemistry, Biochemistry, Biology or Engineering.
5 or more years of experience in administering controlled substances or products with strict regulatory guidelines.
Strong working knowledge of DEA regulatory requirements highly beneficial.
Responsible for monitoring and maintaining compliance with DEA regulations pertaining to shipping, manufacturing, analytical and research activities associated with controlled substances and listed chemicals.
Maintain all related registrations with DEA and other agencies as needed.
Maintain State licensure program.
Complete associated reporting requirements.
Complete and file ARCOS quarterly and year end reports.
Maintain CS and listed chemical files including those pertaining to shipping, receiving, 222 forms, ARCOS reports and correspondence with the DEA or appropriate State agencies.
Interface with DEA as needed, including written, oral and face to face interactions.
Maintain records and correspondence relating to the destruction of CS.
Maintain complete and accurate records pertaining to CS related operations and lab handling.
Complete, reconcile and report all CS and listed chemical inventories.
Assist all departments with CS related issues.
Prepare and conduct employee training on DEA requirements and related site SOP's as needed.
Author and maintain site SOP's and policies relating to CS operations and handling.
Work with Sales/Marketing and customers to obtain appropriate volume requests for CS quota.
Liaise with customers and represent the site during audits and inspections related to CS handling.
Participate on project teams for new project onboarding; liaise with DEA as needed to facilitate CS-related issues such as registration updates, quota needs, controlled status determinations, etc.
Oversee shipment of CS, including import, export and management of suspicious order monitoring program.
Oversee security programs related to CS handling and mfg.
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
All employees are expected to report to work regularly and promptly.
Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Auto-ApplyAssociate Director, Capital Projects
Homestead, IA jobs
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview The Associate Director of Capital Projects is responsible for the strategic planning, execution, and oversight of capital projects at the CDMO site.
This role provides leadership for project management, engineering design, procurement, construction, and validation of facilities, utilities, and manufacturing equipment.
The position ensures that all projects meet regulatory compliance requirements (cGMP, FDA, OSHA), are delivered on time and within budget, and align with business goals and operational excellence initiatives.
Responsibilities Lead the planning and execution of site capital projects from concept through handover, ensuring quality, safety, cost, and schedule objectives are met.
Develop and manage multi-million-dollar capital budgets and resource plans in collaboration with site leadership and global engineering teams.
Oversee cross-functional teams including engineering, validation, quality, procurement, and operations personnel to ensure project alignment with site needs.
Act as the primary liaison with external architects, engineers, contractors, and regulatory authorities for capital initiatives.
Ensure all projects comply with GMP, environmental, health and safety (EHS), and regulatory requirements.
Provide technical leadership in facility design, utility systems (HVAC, WFI, clean steam), and process equipment implementation.
Drive risk management strategies, contingency planning, and change control processes throughout project lifecycles.
Prepare and present project updates, metrics, and risk assessments to senior management and stakeholders.
Mentor and develop junior and experienced project engineers to support a high-performance project team.
All employees are required to adhere to OSHA, DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
All employees are expected to report to work regularly and promptly.
Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications/Skills Strong knowledge of GMP regulations, validation practices, and pharmaceutical production processes.
Proficient in project management tools (MS Project, Primavera, etc.
) and capital planning software.
Excellent communication, negotiation, and leadership skills.
Ability to work collaboratively in a fast-paced, matrixed environment.
Education, Experience & Licensing Requirements Bachelor's degree in Engineering, Construction Management, or a related field required; Master's degree preferred.
Minimum of 10 years of experience in capital project execution within the pharmaceutical, biotech, or CDMO industry.
At least 5 years in a leadership or managerial capacity overseeing cross-functional project teams.
Demonstrated experience managing complex capital projects ($10M+) in a regulated manufacturing environment.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
#LI-RD1Bachelor's degree in Engineering, Construction Management, or a related field required; Master's degree preferred.
Minimum of 10 years of experience in capital project execution within the pharmaceutical, biotech, or CDMO industry.
At least 5 years in a leadership or managerial capacity overseeing cross-functional project teams.
Demonstrated experience managing complex capital projects ($10M+) in a regulated manufacturing environment.
Lead the planning and execution of site capital projects from concept through handover, ensuring quality, safety, cost, and schedule objectives are met.
Develop and manage multi-million-dollar capital budgets and resource plans in collaboration with site leadership and global engineering teams.
Oversee cross-functional teams including engineering, validation, quality, procurement, and operations personnel to ensure project alignment with site needs.
Act as the primary liaison with external architects, engineers, contractors, and regulatory authorities for capital initiatives.
Ensure all projects comply with GMP, environmental, health and safety (EHS), and regulatory requirements.
Provide technical leadership in facility design, utility systems (HVAC, WFI, clean steam), and process equipment implementation.
Drive risk management strategies, contingency planning, and change control processes throughout project lifecycles.
Prepare and present project updates, metrics, and risk assessments to senior management and stakeholders.
Mentor and develop junior and experienced project engineers to support a high-performance project team.
All employees are required to adhere to OSHA, DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
All employees are expected to report to work regularly and promptly.
Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
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