Senior Medical Director, Late Development, Breast Oncology
Cambridge, MA jobs
This position is for a Senior Medical Director within the atirmociclib program. This individual contributor will be responsible for supporting clinical trial(s) and lead sub teams in clinical development. The successful candidate should ideally have prior experience in clinical trials, supporting development programs, health authority interactions and demonstrated leadership capabilities to ensure that the clinical development program meets scientific, ethical, and regulatory standards.
Job Responsibilities
Clinical Development Leadership on Study Teams and Development Subteams
Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
Lead peer-to-peer interactions with investigators
Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.
Provide clinical development leadership across several study teams.
Serve as the Clinical Development Lead on subteams including for Marketing Authorization Applications.
Strategic Guidance, Clinical Insights & Interpretation
Collaborate with the Global Development Team to create and refine development strategies.
Represent the company in external engagements or as committee member in joint collaborations.
Collaborate with Clinical Scientists to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
Maintain a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.
Basic Qualifications
Medical degree with 5+ years of industry experience
Clinical oncology experience (typically 4+ years)
Preferred Qualifications
Board certified/eligible in oncology or equivalent preferred
Breast Oncology experience (2+ years)
Organizational Relationships
Reports to Global Development Lead and partners closely with subject matter experts within cross-functional study team, Pfizer Oncology Division and counterparts in other divisions within Pfizer.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to scientific conferences / meetings several times per year, as needed
Relocation support available
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $242,000.00 to $403,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ...@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Medical
Medical Director
Raleigh, NC jobs
Med First is committed to expanding access to high-quality primary care in underserved communities. We're looking for a Medical Director who can lead with both clinical excellence and operational insight- advancing value-based care and sustainable growth across 25+ clinics.
How You'll Make an Impact:
Lead clinical strategy, quality, and patient safety across diverse, community-based settings
Advance value-based care, care management, and use of innovative AI models
Partner with operations/finance on access, growth, and performance (MLR, quality, experience)
Develop clinical leaders, recruit/retain talent, and foster a culture of compassion + accountability
Provide direct patient care in one of our primary care sites
Who you are:
Board-certified (FM/IM) with 5+ years of clinical leadership, success in value-based and multi-site environments, and a mission-driven, collaborative mindset.
Location: Hybrid: 2 days work in clinic at our Roxboro NC clinic and 2 days administrative working remotely.
Field Medical Director, Oncology, Malignant Hematology, Mid-Atlantic (non-MD)
Maryland jobs
Why Patients Need You The Oncology Field Medical, Director is responsible for providing therapeutic area/product expertise for the malignant hematology therapeutic area across a broad range of Medical customer segments and initiatives in an assigned territory of DE, MD, DC, VA.
What You Will Achieve
Plan and execute Medical strategy and engagement for appropriate assigned customers within territory of DE, MD, DC, VA , compliantly coordinating with other Pfizer colleagues as needed to achieve Medical objectives.
Maintain required level of knowledge of relevant TA/disease states (malignant hematology) and Pfizer medicines, providing therapeutic area/product information to both internal and external stakeholders as needed.
Serve as a conduit and resource for Medical Information and customer insights, providing requested information to HCPs as allowed by Pfizer guidance and sharing customer viewpoints with Pfizer as appropriate .
Understand the priorities of Pfizer Medical Affairs in order to contribute to Medical content strategy development and execute aligned Field Medical tactics.
Maintain effective and appropriate communication and collaboration among headquarters Medical colleagues, Medical Information, and other Pfizer Field Medical colleagues.
Demonstrate expertise in communication across multiple channels, including, but not limited to, live and virtual presentations in small or large settings, written communication, and telephone or virtual conversations.
Optimize patient centricity of Medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus.
How You Will Achieve It
Deliver approved medical content about Pfizer medicines and relevant topics in the designated therapeutic area.
Identify and seek medical engagement from priority customer segments in assigned Therapeutic Area (malignant hematology).
Provide truthful, accurate, and scientifically supported information in response to direct unsolicited medical requests from HCPs in a manner that complies with all applicable Pfizer guidelines, policies, and procedures.
Lead advisory boards with manager oversight.
Field relevant inbound queries from HCPs via established triage process.
In collaboration with Global Medical Affairs colleagues, partner with Oncology Research & Development and Global Product Development (GPD) in the identification of potential sites for Pfizer-sponsored clinical trials, including identification of sites serving under-represented patient populations in trials.
Appropriately provide Medical support throughout the Investigator Sponsored Research (ISR) process.
Cultivate research and therapeutic area expertise, including familiarity with latest congress data and disease state literature.
Provides Asset leadership.
Understand the principles of study design, methodology, data analysis, and interpretation and communicate these concepts with customers.
Strong territory leadership.
Reactively and proactively communicate with local Patient Advocacy Group(s), as appropriate, in close collaboration with Corporate Affairs and HQ Medical Affairs.
Deliver insights on local patient organization structure, capabilities, and patient population needs.
Serve on Medical and/or TA and asset cross-functional committees, as appropriate.
Represent Pfizer Medical Affairs leadership with clinical/professional associations and/or societies, consistently demonstrating medical professionalism in all interactions.
Mentorship - Onboarding partner, ad board and study lead mentor.
Participate in special projects as needed.
Qualifications
Must-Have
BA/BSc with 8+ years of experience in a health science; OR MBA/MS with 7+ years of experience; OR PharmD, PhD, or equivalent terminal doctoral degree (e.g., Doctor of Nursing Practice) with 5+ years of relevant experience .
Must reside within the territory ( DE, MD, DC, VA). No relocation assistance is available.
Demonstrate a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers and create business impact.
Demonstrate excellent oral and written communication skills.
Demonstrate excellent interpersonal skills: ability to understand and respond to multiple external and internal customers' demands and manage and handle conflict constructively.
Demonstrate ability to manage a significant volume of projects developed in a remote environment, while exhibiting the ability to prioritize, successfully implement, and demonstrate excellent judgment skills and work in a continuous improvement environment.
Work within a matrixed, multi-disciplinary team to foster strong Pfizer/customer professional relationships which are aligned with Pfizer Medical objectives.
Effectively manage through and lead change in an ever-changing and evolving external health care environment.
Demonstrate change agility; be flexible to new opportunities (e.g. new therapeutic areas) and adaptable to organizational change.
Problem-solve and network enterprise wide as appropriate to identify solution.
Collaborate effectively and demonstrate leadership and teamwork with peers, internal stakeholders and external customers that inspires alignment and partnership on a shared vision or strategy.
Be a self-starter, be accountable, and have a sense of urgency in delivering results that have medical impact and yield a positive customer experience.
Maintain self-awareness and continually choose behaviors and responses based on how it impacts one's own and others' performance and engagement.
Demonstrate clinical and technical skills.
Rapidly adopt and utilize new digital technology and other resources with medical customers and record medical interactions.
Operate a Pfizer company car and regularly fly on airplanes (i.e. attend HCP/customer meetings; attend NYHQ meetings, etc. required; proximity to airline 'hub' city); maintain flexibility to travel 60-80% of time.
Valid US driver's license and driving record in compliance with company standards. Any DUI/DWI or other impaired driving citation within the past 7 years will disqualify you from being hired.
Nice-to-Have
PharmD, PhD, or equivalent terminal doctoral degree (e.g., Doctor of Nursing Practice, Doctor of Physical Therapy) highly preferred.
Malignant hematology experience in multiple myeloma and/or lymphoma strongly preferred.
Field based medical experience in the pharmaceutical industry preferred.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
Ability to operate a Pfizer company car and regularly fly on airplanes (i.e. attend HCP/customer meetings; attend NYHQ meetings, regional and national scientific and business meetings, etc.) is required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Flexibility to travel 60-80% of time.
Reasonable proximity to airline 'hub' city
Ability to work on weekends occasionally (e.g. attend advisory boards and congress meetings)
Work Location Assignment: Remote - Field Based
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue . click apply for full job details
Senior Medical Director, Late Development, Breast Oncology
New York, NY jobs
This position is for a Senior Medical Director within the atirmociclib program. This individual contributor will be responsible for supporting clinical trial(s) and lead sub teams in clinical development. The successful candidate should ideally have prior experience in clinical trials, supporting development programs, health authority interactions and demonstrated leadership capabilities to ensure that the clinical development program meets scientific, ethical, and regulatory standards.
Job Responsibilities
Clinical Development Leadership on Study Teams and Development Subteams
Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
Lead peer-to-peer interactions with investigators
Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.
Provide clinical development leadership across several study teams.
Serve as the Clinical Development Lead on subteams including for Marketing Authorization Applications.
Strategic Guidance, Clinical Insights & Interpretation
Collaborate with the Global Development Team to create and refine development strategies.
Represent the company in external engagements or as committee member in joint collaborations.
Collaborate with Clinical Scientists to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
Maintain a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.
Basic Qualifications
Medical degree with 5+ years of industry experience
Clinical oncology experience (typically 4+ years)
Preferred Qualifications
Board certified/eligible in oncology or equivalent preferred
Breast Oncology experience (2+ years)
Organizational Relationships
Reports to Global Development Lead and partners closely with subject matter experts within cross-functional study team, Pfizer Oncology Division and counterparts in other divisions within Pfizer.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to scientific conferences / meetings several times per year, as needed
Relocation support available
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $242,000.00 to $403,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Medical
Medical Director of Ambulatory Informatics
North Adams, MA jobs
Berkshire Health Systems seeks a collaborative, visionary clinician to serve as Medical Director of Ambulatory Informatics. This strategic leader will partner with Medical Group, Community Partners, Command IT, the BHS CMIO, and the CIO to leverage data, technology, and clinical expertise to transform outpatient care across primary care and multiple specialty practices. The role splits clinical and leadership responsibilities: maintain an active ambulatory practice in Meditech Expanse 23 days per week and dedicate 2 days per week to the Medical Director responsibilities.
Key Responsibilities
Clinical informatics strategy: Define and execute the ambulatory informatics vision in collaboration with Medical Group and IT leadership.
EMR optimization: Lead design, implementation, and continuous improvement of EHR workflows, decision support, order sets, and clinical pathways focused on outpatient care.
Workflow improvement: Work with clinical departments to identify efficiency gaps, standardize processes, and implement evidence-based solutions.
Project leadership: Serve as principal clinical advisor on technology projects, ensuring alignment with best practices, regulatory requirements, and organizational goals.
Training and education: Organize and deliver informatics training for new providers and continuous learning programs for clinicians and staff.
Team leadership: Lead and mentor multidisciplinary teams including analysts, informaticists, and trainers; foster cross-departmental collaboration and service excellence.
Vendor and stakeholder engagement: Represent BHS ambulatory needs with Meditech and other vendors, advocating for improvements and prioritizing enhancements for outpatient workflows.
Required Qualifications
Degree and certification: MD or DO from an accredited institution and active board certification
Clinical practice: Current ambulatory clinical practice experience with the ability to maintain clinical sessions 23 days per week.
Informatics experience: Experience in medical informatics, healthcare technology management, or EHR optimization; experience with Meditech Expanse strongly preferred.
Process improvement skills: Demonstrated success with workflow optimization, standardization, and evidence-based order set development.
Communication and leadership: Strong interpersonal and communication skills for effective collaboration with providers, leadership, IT teams, and external vendors.
Passion for improvement: Motivated to make patient care better while simplifying clinicians and staff workflows.
Why Berkshire Health Systems
Impactful work: Lead ambulatory informatics across a diverse outpatient network including primary care and specialties, with direct influence on patient outcomes and clinician experience.
Supportive leadership: Work closely with executive leadership including the COO, CMIO, and CIO, with a clear mandate to drive change.
Innovative environment: Leverage an integrated EHR, telehealth, and data analytics tools to advance quality and population health.
Balanced role: Combine meaningful clinical practice with strategic informatics leadership, preserving strong clinician engagement.
Professional growth: Opportunities to lead cross-functional teams, shape training programs, and represent BHS to vendors and partners.
Living and Working in Western Massachusetts
Quality of life: Berkshire Health Systems is based in the scenic Berkshires, offering a high quality of life with a strong sense of community.
Outdoor and cultural amenities: Easy access to year-round outdoor recreation, cultural institutions, restaurants, and arts festivals.
Affordable living: Competitive cost of living compared with many metropolitan areas while remaining within reasonable driving distance of major cities.
Family friendly: Excellent schools, safe communities, and abundant opportunities for family and personal activities.
RequiredPreferredJob Industries
Other
Regional Medical Affairs Director - Great Plains
Remote
The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified.
Candidate to reside in Denver, CO or St. Louis, MO or Minneapolis, MN
Territory covers: WY, CO, NM, ND, SD, NE, KS, MN, IA, MO, IL, IN
Responsibilities
Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience.
Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information.
Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups.
Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs).
Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc.
Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes
Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development
As identified, contribute to internal training for headquarter- and field-based teams and supporting speaker training initiatives.
Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes.
Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends.
Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications.
Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested.
Performing and completing administrative responsibilities, including reporting requirements in a timely fashion
Qualifications
Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred
Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed]
Active clinical care, clinical research, or academia experience preferred
Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care.
Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution
Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred.
Competencies: Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter.
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Approximately 60% overnight travel
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-REMOTE
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Auto-ApplyMedical Director
Middletown, RI jobs
WHO WE ARE…
Newport Mental Health (NMH) is a progressive high-energy organization that uses state of the art person-centered recovery approach to help individuals recover from mental illness and substance use disorders. NMH extends its trauma informed evidence-based services to children, adolescents, families, and adults. Our services vary from outreach, specialized program, mental health, school-based therapy, substance use therapy, community-based therapy, and outpatient clinic.
For more information visit our website: ***************************
WHO WE ARE LOOKING FOR…
Mission- Aligned: You are excited to be a part of Newport Mental Health's mission to improve the lives of our clients living and working in Newport County by providing the highest quality of care.
Ally: You intentionally foster belonging, personal growth, and empowerment for all. You are a strong advocate for the BIPOC, LQBTQIA+, Woman, Veteran, and other underrepresented communities.
Solution Orientated: You are driven to think of different approaches to narrow the gap which leads to positive and effective changes.
Time Management: You are a conscious planner and a thoughtful decision maker who adheres to deadlines.
WHAT WE OFFER…
Excellent Health and Dental Insurance.
Vacation, Sick and Personal time accrued biweekly.
Up to 11 Paid Holidays.
Retirement program through Mutual of America.
Additional supplemental insurance programs.
Tuition reimbursement.
Mileage reimbursement.
Employer paid life insurance.
Flexible spending account (FSA) and dependent care (DCA) spending accounts.
WHAT YOU WILL BE DOING (ESSENTIAL DUTIES) …
Responsible for the provision and oversight of psychiatric medical services with a diverse patient population. Provides psychiatric assessment and treatment to clients while serving as a consultant to other staff. Participates in quality improvement, quality assurance, peer review and medical staff activities. Participates as a member of the Management Team in the organization's decision-making structures and processes.
Main Duties and Responsibilities:
Translate mission, vision, values, and strategic planning into action plans. Build a shared vision with Agency staff and acts as a positive catalyst of organizational change and growth.
Participate as a member of the Management Team in the organization's decision-making structures and processes.
Co-Chair regular Medical/Clinical Staff Meetings with the Clinical Director.
Responsible for the clinical and administrative supervision and support of all NMH prescribers. Holds staff accountable for meeting standards of care and job expectations including reasonable productivity and no-show standards.
Oversee clinical policy development and adherence.
Set the standards for medical and clinical care.
Chair of the Pharmacy and Therapeutics committee.
Provide clinical guidance, role-models, coaches, and assists in the areas of professional and clinical development, team building, and patient care.
Collaborate with the Chief Executive Officer and Chief Clinical Officer to oversee the quality and effectiveness for the delivery of clinical care in all NMH departments.
Assist in the planning, development, implementation, and oversight of programs, including integrated care. Develop innovative ways, both within the organization and externally, to improve the quality and performance of services.
Support medical staff in the design and fidelity to the Just in Time centralized scheduling process.
Provide leadership to guide the organization's efforts in continuous quality improvement.
Communicate effectively with staff, clients, natural supports, and community partners.
Maintain thorough, timely clinical documentation meeting Federal and State guidelines and standards including medical staff evaluation and monitoring coding.
Ensure the cost effective and efficient delivery of care, and the appropriate utilization of resources based on the MTM productivity modeling tool.
Promote integrated care and care management activities of our Integrated Health Homes and participation in our Integrated Health Partnership Medicaid accountable care initiatives.
Provide consultation to the Chief Executive Officer, Chief Clinical Officer, Chief Operating Officer, Division Directors, Supervisors, and staff regarding medical and psychiatric issues.
Meet leadership standards for the CCBHC Medical Director role and Joint Commission standards.
Maintain familiarity with State and Federal regulations for prescription medications (including controlled substances) and prepare organization policies and procedures to guide the use of prescription medications and controlled substances at NMH.
Participate actively in professional organizations in order to further education, professional growth, and networking.
Obtain and record information about client's medical and psychiatric histories for the purpose of diagnostic formulation and treatment planning.
Conduct comprehensive Psychiatric Assessments.
Conduct and record mental status exams to monitor response to treatment.
Order consultations to assist in difficult diagnostic formulation.
Order and interpret laboratory studies, EKG's, EEGs, and neuroimaging to provide accurate diagnostic information as well as to monitor side effects and other co-occurring medical conditions.
Prescribe and monitor psychotropic medications according to best practice standards and in concert with the Center's policy and procedures and Pharmacy and Therapeutics guidelines.
Discuss risks and benefits and obtain informed consent from client (or personal representative) before initiating pharmacotherapy.
Demonstrate the ability to integrate general medical concerns into psychiatric practice as evidenced by attention to drug interactions, complications of medical illness and behavioral effects of somatic illness.
Provide psycho education to clients and families.
Conduct and supervise treatment of clients with substance use disorders.
Perform emergency assessments and admit to the mental health unit of Newport Hospital, as necessary.
Participate in the Center and Hospital physician on-call coverage schedule.
Provide consultation and follow-up communication with law enforcement agencies, community agencies, medical facilities, and inpatient units.
Participate actively in team communication processes that ensure appropriate management of cases 7 days per week.
Seek and actively participates in regularly scheduled supervision with emphasis on an openness to receive feedback and integrate recommendations in the execution of job responsibilities.
Requirements
WHAT WE EXPECT OF YOU…
Valid, unlimited Rhode Island medical license as an M.D. or D.O.
Completion of a residency program in psychiatry.
Board-eligible or board certified in psychiatry.
Full, unrestricted Licensure to practice psychiatric medicine in the State of Rhode Island.
Full, unrestricted DEA license to prescribe medication.
Minimum five (5) years of clinical practice. Minimum (2) years administrative experience in a psychiatric/behavioral health setting.
APPLY NOW
Submitting your application is a great way to learn more about Newport Mental Health. If you have questions about how your experience aligns with our job openings or know someone who would be a great candidate for our job openings, please contact Human Resources:
Human Resources
Newport Mental Health
42 Valley Road
Middletown, RI 02842
Tel: ************
Fax: ************
Newport Mental Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.
Executive Medical Director, Global Medical Lead - HEME
Boston, MA jobs
Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Hematology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategies for the first FDA approved CRISPR-cas9 medicine (Exa-Cel) for the treatment of Sickle Cell Disease and Infusion dependent B-Thalassemia, including the development of the life cycle management plan. The successful candidate will be an experienced people manager who is passionate about developing talent to whom the HEME Global Medical team will report to. The individual will partner with the International and North America regions to drive globally aligned medical brand and evidence generation plans which reflect country and regional insights and needs. This individual must work effectively with his/her cross-functional counterparts in Development, Research, and Commercial, and will sit on the HEME Disease Strategy Team to define and implement the medical affairs strategy for Exa-Cel.
Key Duties and Responsibilities:
* The Executive Director, HEME Global Strategy, will have global responsibility to build the Global Medical strategy for Exa-Cel.
* Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance.
* Execute the Global components of the medical strategy plan.
* Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and partner functions to identify evidence gaps and coordinate evidence generation to generate data in support of global product initiatives.
* Ensure all Medical Affairs initiatives are aligned with overall brand plans and in compliance with corporate policies and regulatory requirements.
* Determine staffing requirements for the group and successfully recruit, develop and retain an effective team. The successful candidate will evaluate and update process and operating procedures for this group that are consistent with general guidance already in place for the organization.
Knowledge and Skills:
* Proven relationship building competencies with external stakeholders
* Excellent understanding of healthcare systems in assigned region and the needs of payors
* Overall strong ability to understand the disease state, mechanism of action, value proposition - both from an absolute and relative/competitive standpoint.
* Strong speaking and presentations skills to ensure trustful and authoritative interactions with all stakeholders sets (KOLs, payers, patients, patient advocacy groups, etc.).
* Clear understanding of the Pharma industry environment and ability to build and create a strong strategic plan in collaboration with the Global Medical team and other stakeholders.
* Ability to work comfortably within a cross-functional and matrix environment.
* Therapeutic experience is preferred
* Experience of working in a regional medical affairs role is highly desirable
* Travel up to 30% required.
Education and Experience:
* The successful candidate will have a medical degree or PhD from a well-regarded institution and at least 7 years of experience in industry, with at least 3 of those in an industry managerial role leading clinical and/or medical programs. The ideal candidate will have sub-specialty training in Hematology / Transplant medicine.
* In addition to deep technical competence, she/he will exhibit sound business judgment with an understanding of the significant financial investments and the ultimate impact that the role has on product opportunities and on the Company.
* The Executive Director, HEME Global Strategy will be a natural leader, possessing the skills to build, lead, develop and work with teams and individuals in a global, functionally matrixed environment.
* The successful candidate will possess excellent communication and relationship skills. S/he will communicate with a style that is clear, complete and concise. S/he will have well-established networks and be able to develop and maintain strong professional relationships internally and externally by gaining credibility and confidence with others.
Pay Range:
$311,200 - $466,800
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyRegional Medical Affairs Director - Great Plains
Denver, CO jobs
The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified.
**Candidate to reside in Denver, CO or St. Louis, MO or Minneapolis, MN**
**Territory covers: WY, CO, NM, ND, SD, NE, KS, MN, IA, MO, IL, IN**
**Responsibilities**
+ Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience.
+ Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information.
+ Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups.
+ Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs).
+ Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc.
+ Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes
+ Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development
+ As identified, contribute to internal training for headquarter- and field-based teams andsupporting speaker training initiatives.
+ Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes.
+ Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends.
+ Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications.
+ Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested.
+ Performing and completing administrative responsibilities, including reporting requirements in a timely fashion
**Qualifications**
+ Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred
+ Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed]
+ Active clinical care, clinical research, or academia experience preferred
+ Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care.
+ Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution
+ Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred.
+ Competencies:Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter.
+ Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.Approximately 60% overnight travel
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-REMOTE
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US_
**Title** _Regional Medical Affairs Director - Great Plains_
**ID** _2025-2266_
**Category** _Medical Affairs_
**Type** _Full-Time_
Regional Medical Affairs Director - Gulf Coast
Houston, TX jobs
The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified.
**Candidate to reside in Houston, TX**
**Territory covers: TX, LA, MS**
**Responsibilities**
+ Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience.
+ Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information.
+ Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups.
+ Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs).
+ Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc.
+ Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes
+ Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development
+ As identified, contribute to internal training for headquarter- and field-based teams andsupporting speaker training initiatives.
+ Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes.
+ Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends.
+ Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications.
+ Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested.
+ Performing and completing administrative responsibilities, including reporting requirements in a timely fashion
**Qualifications**
+ Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred
+ Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed]
+ Active clinical care, clinical research, or academia experience preferred
+ Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care.
+ Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution
+ Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred.
+ Competencies:Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter.
+ Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.Approximately 60% overnight travel
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-REMOTE
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US_
**Title** _Regional Medical Affairs Director - Gulf Coast_
**ID** _2025-2267_
**Category** _Medical Affairs_
**Type** _Full-Time_
Veterinarian Medical Director - Owner/Partner Option!
Palmdale, CA jobs
High Desert Animal Care Hospital, located in the beautiful Palmdale, CA area, is a fast-paced small animal practice! For over 30 years, we've been providing exceptional care to our local patients-from routine check-ups to complex surgeries-handling everything from urgent walk-ins to challenging cases.
Whether it's diving into a busy day of appointments, tackling new challenges, or learning and growing as a team, we're always in it together. If you're ready to join a dedicated, fun-loving team that looks forward to coming to work every day, this is the place for you!
Why join us?
* Thriving culture: Our close-knit staff enjoys a positive work environment
* Strong support staff: Our DVMs love having a support staff that is highly trained with tenured team members
* Benefits: We offer DVMs extensive benefits including a sign-on bonus, relocation assistance, student loan reimbursement, future ownership opportunities, etc.!
* Future Partnership Opportunity: Qualify for equity or ownership through our Partner Track program following successful employment. Interested? Ask us for more details!
Services Include: Routine Care, Dentistry, In-House Diagnostics, Cold Laser Therapy, Digital X-Rays, Ultrasounds, Complete Surgical Suite, etc. Learn more about our hospital here.
Visit Our Website to Learn More!
Our Palmdale and Antelope Valley veterinarian office is very easy to get to and is about an hour outside of Hollywood, CA. Palmdale truly has something for everyone! Whether you're exploring scenic parks, hiking trails, or enjoying live music and delicious dining, there's always something to do. Plus, you're just a short drive from LA's dynamic city scene, breathtaking beaches, and snowy mountain peaks perfect for skiing.
Job Description
As the Medical Director Veterinarian, you will serve as the pivotal leader of our hospital. Your role encompasses a broad range of responsibilities, including but not limited to leadership and staff management, client relations, medical quality assurance, financial oversight of the practice in partnership with Regional Manager. This role is integral to the success of our hospital, and we are excited to have you bring your expertise and leadership to our team.
We offer our veterinarians:
* Flexible Scheduling & Medical Autonomy
* Comprehensive Benefits (paid vacation/sick time/holidays, health, dental, vision, liability, 401K, life & supplemental insurance, employee assistance program & personal pet care discounts)
* Future Ownership Opportunities
* Competitive Compensation
* DVM Mentor Network
* Paid CE Allowance & Professional Dues
Salary Range can vary from $150,000 to $220,000, with flexibility based on experience! Determining factor is solely based off experience, qualifications, schedule, compensation structure, and is subjected to change per applicable candidate.
+Additional Medical Director Stipend can apply!
+High volume clinic with high earning potential through production!
Qualifications
* Doctor of Veterinary degree, or equivalent, from an accredited university
* Active veterinary state license
* Current DEA License preferred but not required
* USDA Accreditation preferred but not required
Additional Information
WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER.
Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin
#IND5
Clinical Development Medical Director- Neurology
Boston, MA jobs
The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development.
Key Duties and Responsibilities:
* Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
* Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
* Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
* Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies
* Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
* Performs other duties as assigned related to clinical programs
Knowledge and Skills:
* Excellent oral and written communication skills
* Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate
* Effective at building alliances across functions, based on end-to-end drug development thinking and experience
Education and Experience:
* MD, DO or equivalent ex-US medical degree
* Board certification/eligibility in a specialty field is highly desired
* Typically requires 10 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience
* Typically requires experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design
* Typically requires experience with design, execution, and analysis of clinical trials required
#LI-AR1
Pay Range:
$237,200 - $355,700
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyRegional Medical Affairs Director - Southwest
Dallas, TX jobs
The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified.
**Candidate to reside in Dallas, TX or Phoenix, AZ**
**Territory covers: TX, OK, NM, KS, AZ**
**Responsibilities**
+ Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience.
+ Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information.
+ Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups.
+ Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs).
+ Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc.
+ Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes
+ Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development
+ As identified, contribute to internal training for headquarter- and field-based teams andsupporting speaker training initiatives.
+ Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes.
+ Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends.
+ Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications.
+ Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested.
+ Performing and completing administrative responsibilities, including reporting requirements in a timely fashion
**Qualifications**
+ Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred
+ Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed]
+ Active clinical care, clinical research, or academia experience preferred
+ Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care.
+ Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution
+ Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred.
+ Competencies:Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter.
+ Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.Approximately 60% overnight travel
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-REMOTE
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US_
**Title** _Regional Medical Affairs Director - Southwest_
**ID** _2025-2268_
**Category** _Medical Affairs_
**Type** _Full-Time_
Veterinarian Medical Director
Los Angeles, CA jobs
Eagle Rock Pet Care is an established clinic that understands the deep bond between pets and their owners. We are located in Eagle Rock, CA and excited to be hiring a Medical Director to join our team! At Eagle Rock Pet Care, we're all about creating a place where you feel supported, valued, and excited to come to work every day. We see a wide variety of cases-including exotics-so there's always something new to learn and opportunities to grow. Here, you'll find a team that genuinely cares about helping each other thrive and making a difference for our patients. If you're looking for a welcoming, ambitious practice where learning is part of the daily routine, we'd love to meet you.
Why choose us?
* Practice Type: General Practice/Small Animal clinic with some exotics
* Excellent Benefits: OFFERING SIGN-ON BONUS, RELOCATION ASSISTANCE, STUDENT LOAN ASSISTANCE, FUTURE OWNERSHIP OPTIONS, ETC.!
* Medical Autonomy: Shape the future of this clinic, your way!
Services Include: Routine Care, Surgery, In-House Diagnostics, Ultrasound, EKG, Exotics Care, and more.
Learn More About Our Hospital! Check out our website here!
Eagle Rock, CA is a historic neighborhood located in the Northeast Los Angeles area. It is the perfect blend of laid-back neighborhood charm and access to everything Los Angeles offers. Enjoy lazy afternoons hiking Griffith Park or catching a show at the Hollywood Bowl. Shop and dine at The Grove, explore art in Pasadena, or unwind on Santa Monica's beaches-all just a short drive away. Explore all Eagle Rock has to offer!
Job Description
* Part Time or Full Time Veterinarian
* Proficient in general medicine and surgery
Salary Range can vary from $150,000 to $200,000. Determining factor is solely based off experience, qualifications, schedule, compensation structure, and is subjected to change per applicable candidate.
We offer our veterinarians:
* Flexible Scheduling & Medical Autonomy
* Comprehensive Benefits (paid vacation/sick time/holidays, health, dental, vision, liability, 401K, life & supplemental insurance, employee assistance program & personal pet care discounts)
* Future Ownership Opportunities
* Competitive Compensation
* DVM Mentor Network
* Paid CE Allowance & Professional Dues
Qualifications
* Doctor of Veterinary degree, or equivalent, from an accredited university
* Active veterinary state license
* Current DEA License
* USDA Accreditation
* Strong leadership skills
Additional Information
WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER.
Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin
Medical Director Veterinarian
Crete, IL jobs
The Gist of the Role Looking for a change of scenery? We're looking for a Medical Director DVM to join our rustic practice found just a commutable stone's throw away from Chicago. Our charming red barn setting offers a peaceful escape from the bustling city yet is still conveniently close by. With flexible scheduling, you can enjoy a healthy work/life balance (AKA: work, then catch a show in Chicago!)
Our compassion-driven culture promotes medical autonomy, allowing you to practice veterinary medicine on your own terms. Plus, our Partner Track program offers ownership opportunities and flexibility to invest in your medical interests. Join our team and experience the satisfaction of making a meaningful impact on the lives of pets and their owners while building a successful and fulfilling career.
Job Description
More About Our Practice
Plum Creek Animal Medical Center is a well-established, progressive, fast-paced 3 doctor small animal practice with a nearby outpatient clinic. We are proud to be a 25-year AAHA-Certified hospital. Plum Creek offers many services to supply the best comprehensive care to our patients including Wellness and Preventive Care, Illness, Problem and Urgent Care, Surgery, Dentistry, Therapeutic Laser Therapy, In-House Diagnostics, Digital full body and dental radiology, Ultrasonography, Acupuncture, Medical and/or Vacation Boarding and more.
Our charming red barn setting supplies the perfect escape from the hustle and bustle of Chicago while still being close to the city. We highly value work-life balance and offer flexibility on scheduling, so you can enjoy your personal life without sacrificing your career. Our limited-service outpatient clinic provides doctors and staff with the ability to enjoy variety while the records and clients are shared between locations.
You're here for pets, we're here for you.
* Flexible scheduling for work-life balance
* Medical autonomy to practice medicine your way
* Future ownership opportunities
* Just a short distance from Chicago
* Extremely generous signing bonuses
* Full benefits - PTO, health/dental/vision/life insurance, 401K, pet care discounts, etc.
* Competitive compensation
* DVM mentor network
* Paid CE allowance & professional dues
* Also offering relocation assistance and student loan aid
* Commuter stipend for gas/tolls if needed
We're Looking For
* Full time veterinarian- Medical Director
* Compassionate, team player and strong communicator
* Proficient in general medicine and surgery
* Experience preferred but new graduates seeking mentorship are encouraged to apply!
#IND5
Qualifications
* Doctor of Veterinary degree, or equivalent, from an accredited university
* Current DEA License or obtained upon hire
* Active Veterinary State License
* USDA Accreditation or obtained upon hire
Salary Range can vary from $100,000 to $150,000. Determining factor is solely based off experience, qualifications, schedule, compensation structure, and is subjected to change per applicable candidate.
Additional Information
Hiring eligibility may be contingent to a candidate authorizing and completing a satisfactory background check.
WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER.
Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin
Executive Medical Director, Patient Safety (Hybrid)
Boston, MA jobs
The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex's world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.
Key Duties and Responsibilities:
* Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.
* Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.
* Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.
* Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.
* Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.
* Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.
* Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.
* Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.
* Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.
* Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.
* Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.
* Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
* Reviews and provides oversight of safety sections of clinical study reports.
* Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.
* Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.
* Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
* Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.
* Facilitates the growth and development of staff and direct reports.
Knowledge and Skills:
* Extensive knowledge of GCP, ICH and Global regulations.
* In-depth and comprehensive knowledge of General Medicine.
* Strong leadership skills with the ability to communicate effectively in a matrix environment.
* Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.
* Extensive knowledge of Benefit-Risk strategies and decision-making.
* Ability to multi-task, adeptly handling multiple demands.
Education and Experience:
* MD, DO or equivalent ex-US medical degree
* 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience
#LI-AR1
Pay Range:
$312,000 - $468,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyAssociate Director Medical Writing (Hybrid)
Boston, MA jobs
The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments.
This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package.
Key Duties and Responsibilities:
* Independently authors routine and complex clinical and regulatory documents
* Provides strategic input into program-level plans
* Deep insight into how different functions contribute to the successes of the team
* Aligns, coordinates, and builds consistent information and messages across clinical program(s)
* Provides leadership related to the activities of Medical Writing Science and manages a team
* Participates in developing and implementing goals and initiatives for Medical Writing Science
* Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents
* Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements
Knowledge and Skills:
* Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives
* Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues
* Proven track record of anticipating potential problems and preparing contingency plans as needed
* Understanding of scientific disciplines beyond own specialty area
* Experience managing direct reports and guiding staff development
* Experience with marketing authorization application regulatory submissions
Education and Experience:
* Bachelor's degree in relevant discipline
* Ph.D. (or equivalent degree)
* Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience
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#LI-Hybrid
Pay Range:
$157,600 - $236,400
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Remote-Eligible
Flex Eligibility Status:
In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Remote
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplySenior Director, Medical Writing
Boston, MA jobs
Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options.
The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence.
The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines.
The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation.
Responsibilities:
Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals.
Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization.
Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents.
Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials.
Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines.
Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices.
Represent Medical Writing and provide medical writing expertise on cross-functional teams.
Develop detailed timelines for document development in line with company goals and SOPs.
Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers.
Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables).
Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable.
Coordinate with the Regulatory Operations team to publish documents that meet eSubmission‑ready standards.
Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates.
Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations.
Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable.
Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines.
Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC).
Qualifications:
BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred
Success in managing resources (internal, external, or hybrid)
Prior direct experience leading medical writing teams responsible for global marketing authorization applications
Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle
Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines.
Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
Excellent technical writing and editorial skills; excellent attention to detail
Strong ability to understand and interpret medical and scientific data
Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint
Experience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNote
Excellent communication, interpersonal, and organizational skills
Experience working on cross-functional teams
Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
Ironwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.
#LI-Hybrid
Auto-ApplySenior Medical Director - Medical Safety Evaluation
Los Angeles, CA jobs
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG.
Job Description
Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues.
KEY RESPONSIBILITIES
As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety
Provides oversight of medical safety evaluation for assigned global investigational products
Coordinates and contributes to medical assessment for assigned global post-marketing products
Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation.
Partner with relevant internal and/or external experts to fulfill responsibilities
Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities.
Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned.
Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing
Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies
Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate)
Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications
Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation
Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data
Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs
Oversees development and preparation of Risk Management Actions Plans for regulatory filings
Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements
Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities
Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department.
Qualifications
Education:
* Medical Degree (MD or DO), and current medical license preferred
* Board Certification or equivalent in a medical specialty and significant clinical experience
Professional Experience:
* Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions
* Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry
* Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans
* Post-graduate training in clinical epidemiology and biostatistics is also desirable
* Ability to travel domestically & internationally as required, typically up to 30%
Knowledge and Skills:
* Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization
* Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines)
* Experience in Phase II/III trials, especially with key safety activities
* Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols)
* Demonstrated authorship of PSUR, REMS or RMP, and DSUR
* Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion
* Experience with ARISg or other safety database programs
Additional Information
Our 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 Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Auto-ApplyAssociate Director/Director of Medical Engagement
Ann Arbor, MI jobs
Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.
Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.
Position Title: Associate Director/Director of Medical Engagement
The Associate Director/Director of Medical Engagement will represent Esperion's commitment to advancing patient care and scientific innovation by engaging with healthcare professionals, researchers, and key stakeholders to deliver scientific information, identify insights, and establish long-term partnerships. These roles reflect a progression of responsibilities, with the Associate Director role focusing on functional area leadership and the Director role encompassing strategic leadership, cross-functional collaboration, and direct field team management. Ideal candidate will be based in the Boston, MA area.
Territory: Upstate NY, CT, RI, MA, VT, NH, and ME
Essential Duties and Responsibilities*
Engage with Thought Leaders (TLs): Build and maintain trusted relationships with healthcare professionals, academic centers, and researchers aligned with Esperion's mission.
Scientific Exchange: Deliver and discuss current and emerging scientific data on hypercholesterolemia, ensuring high-quality educational interactions with external stakeholders.
Clinical and Scientific Expertise: Develop expertise in cardiometabolic and lipid-related science, Esperion's product portfolio, and emerging clinical trends.
Strategic Insight Capture: Gather field insights on unmet needs, treatment landscapes, and competitive intelligence to refine Esperion's strategies.
Congress and Event Participation: Represent Esperion at medical congresses, roundtable discussions, advisory boards, and educational programs.
Cross-Functional Collaboration: Partner with internal teams as appropriate, including Market Access, Marketing, Clinical Development, Regulatory, to align scientific and commercial strategies.
Compliance: Ensure adherence to all corporate policies, U.S. healthcare laws, and industry regulations in all scientific engagements.
*Additional duties and responsibilities based on level as assigned such as:
Associate Director:
Lead scientific initiatives within the functional area, including internal and external projects.
Mentor and guide MSLs as appropriate, fostering professional development within the team.
Contribute to Medical Affairs strategy development for congress planning, scientific publications, and real-world evidence initiatives.
Collaborate on the development of health system quality improvement initiatives.
Serve as a subject matter expert in cardiometabolic care, providing advanced scientific guidance to internal and external stakeholders.
Ensure compliance with corporate policies, U.S. healthcare laws, and industry regulations in all scientific engagements.
Director:
Lead strategic external engagement with Integrated Delivery Networks (IDNs), health systems, and high-level stakeholders to establish long-term partnerships.
Develop and execute long-term strategies for partnerships and scientific initiatives that align with Esperion's mission.
Lead and coordinate cross-functional teams to ensure alignment of scientific, clinical, and commercial objectives in an appropriate and compliant manner.
Champion high standards of compliance, ethics, and patient safety across all scientific and medical activities.
Field Team Management: Provide leadership, mentorship, and performance oversight for field-based medical engagement teams, including MSLs and ADs, ensuring a positive and collaborative culture.
Qualifications (Education & Experience)
Advanced degree required (MD, PhD, PharmD, or equivalent); NP or PA with relevant experience may be considered.
Associate Director: At least 5+ years of relevant experience, including leadership or mentoring responsibilities.
Director: At least 8+ years of pharmaceutical or clinical experience, including leadership roles managing teams and external stakeholder engagement.
Director: Proven ability to develop and execute long-term strategic initiatives
Director: Strategic vision with cross-functional leadership and team management capabilities.
Demonstrated ability to lead functional area projects and initiatives.
Expertise in cardiovascular, cardiometabolic, or lipidology required.
Strong scientific knowledge and ability to communicate complex medical concepts to diverse audiences.
Exceptional communication and interpersonal skills to build trust and credibility with stakeholders.
Analytical mindset with attention to detail and problem-solving capabilities.
Adaptability to thrive in a fast-paced, dynamic environment with competing priorities.
Demonstrated leadership and ability to manage functional area initiatives while mentoring others.
Outstanding organizational, planning, and project management skills.
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and CRM software.
Valid U.S. driver's license with the ability to travel >50% (including overnight travel).
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