Senior Medical Director / Medical Director, Pharmacovigilance Job at Beam Therapeutics (Cambridge, MA)

Medical Director, Pharmacovigilance

Reporting to the Senior Medical Director, Global Patient Safety and Pharmacovigi...

Location

United States , Waltham

Salary:

205000.00 - 250000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of experience in global pharmacovigilance
2+ years of experience in clinical practice or academic medicine
Proven experience in safety data analysis, signal management, and benefit-risk evaluation
Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
Demonstrated ability to develop and implement drug safety strategies, risk management plans, and safety governance models
Proven experience with authoring or contributing to clinical study and regulatory submission documents
Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Experience in creating or managing working documents such as SOPs or Work Instructions
Strong ability to proactively identify risks and initiate/manage risk minimization activities

Job Responsibility

Provide expert medical interpretation of safety data from all sources and perform medical review of Individual Case Safety Reports (ICSR) within the ARGUS database
Oversee and execute safety signal detection and evaluation activities
Incorporate insights from real-world data into surveillance and benefit-risk assessments
Lead the development and oversight of global benefit-risk assessments and safety surveillance
Drive the lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies
Lead the authoring and medical review of safety sections for regulatory documents and safety modules for marketing applications
Support labeling decisions and contribute medical expertise to safety communications
Collaborate with cross-functional stakeholders to integrate safety considerations
Lead and inspire a team of PSPV MDs, scientists, and operational colleagues
Partner with senior leadership on departmental goals, organizational design, budgeting, and long-term pharmacovigilance planning

What we offer

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities

Fulltime

Director, Medical Affairs - Osteoporosis

As an Associate Director / Director, Global Medical Affairs at Theramex, you wil...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Qualified medical professional (Degree in Human Medicine)
Proven Medical Affairs knowledge and expertise (ideally in women’s health or related)
Leadership experience—preferably at international scale
Solid experience in healthcare professional engagement
Outstanding communication and collaboration skills
Strong business acumen
Highest ethical standards with strong command of compliance and international health authority requirements
Final ABPI signatory status
Strategic, pragmatic, and agile—thriving in fast‑paced, complex environments while delivering measurable outcomes
Passionate about women’s health and motivated to create tangible impact through science and education

Job Responsibility

Own and develop the global medical strategy for a portfolio of pharmaceutical products within the therapeutic area
Design and implement Medical Operating Plans in close collaboration with brand/product directors and other cross‑functional teams
Plan and supervise evidence generation projects (e.g., real‑world evidence)
Review and approve investigator‑initiated studies
Lead scientific publications, presentations, and dissemination of medical‑scientific data both internally and externally
Establish and maintain relationships with Global key medical experts, Healthcare providers, Academic institutions, Government agencies, Medical‑scientific societies, Advocacy groups
Create and implement engagement plans for medical‑scientific experts and patient advocacy groups
Lead advisory boards and other strategic scientific forums
Act as a senior medical‑scientific consultant to internal stakeholders, including Commercial brand teams, Regulatory Affairs, Market Access, Business Development, Other internal partners
Facilitate alignment across functions to ensure medical‑scientific integrity

What we offer

A fast‑paced environment with broad exposure, where you can grow—even beyond your area of expertise
A culture that supports continuous learning, celebrates success, and recognises high performance
Opportunities for driven, talented professionals who want to be part of our ambitious, purpose‑led journey

Director, Global Medical Affairs - Uterine Health

As an Associate Director / Director, Global Medical Affairs at Theramex, you wil...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Qualified medical professional (Degree in Human Medicine)
Proven Medical Affairs knowledge and expertise (ideally in women’s health or related)
Leadership experience, ideally at international scale
Solid experience in healthcare professionals engagement
Outstanding communication and collaboration skills
Strong business acumen
Highest ethical standards with command of compliance and international health authorities’ requirements
Final ABPI signatory status
Strategic, pragmatic and agile operator who thrives in fast-paced, complex environments and delivers measurable outcomes
Passionate about women’s health and driven to make a tangible impact through science and education

Job Responsibility

Own and develop the global medical strategy for a portfolio of pharmaceutical products within the therapeutic area
Design and implement Medical Operating Plans in close collaboration with brand/product directors and other cross-functional teams
Plan and supervise evidence generation projects (e.g. real-world evidence)
Review and approve investigator-initiated studies
Lead scientific publications, presentations, and dissemination of medical-scientific data internally and externally
Establish and maintain relationships with global key medical experts, healthcare providers, academic institutions, government agencies, medical-scientific professional societies and advocacy groups
Create and implement key medical-scientific experts and patient advocacy groups engagement plans
Lead advisory boards and other strategic scientific forums
Act as a senior medical-scientific consultant to internal stakeholders, including commercial brand teams, regulatory affairs, market access, business development, other
Facilitate alignment across functions to ensure medical-scientific integrity

What we offer

A fast-paced environment with broad exposure, where you can grow—even beyond your area of expertise
A culture that supports continuous learning, celebrates success, and recognizes performance
Opportunities for driven, talented professionals who want to be part of our ambitious, purpose-led journey

Director, Global Medical Affairs - Uterine Health

As Director, Global Medical Affairs at Theramex, you will be a critical member o...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Qualified medical professional (Degree in Human Medicine) with proven Medical Affairs knowledge and expertise (ideally in women’s health or related) as well as leadership experience, ideally at international scale
Solid experience in healthcare professionals engagement, with outstanding communication and collaboration skills
Strong business acumen
Highest ethical standards with command of compliance and international health authorities’ requirements
Final ABPI signatory status
Strategic, pragmatic and agile operator who thrives in fast-paced, complex environments and delivers measurable outcomes
Passionate about women’s health and driven to make a tangible impact through science and education.

Job Responsibility

Strategic Leadership: Own and develop the global medical strategy for a portfolio of pharmaceutical products within the therapeutic area
Design and implement Medical Operating Plans in close collaboration with brand/product directors and other cross-functional teams
Evidence Generation Strategy and Oversight: Plan and supervise evidence generation projects (e.g. real-world evidence)
Review and approve investigator-initiated studies
Evidence Dissemination Strategy and Oversight: Lead scientific publications, presentations, and dissemination of medical-scientific data internally and externally
External Engagement: Establish and maintain relationships with global key medical experts, healthcare providers, academic institutions, government agencies, medical-scientific professional societies and advocacy groups
Create and implement key medical-scientific experts and patient advocacy groups engagement plans
Lead advisory boards and other strategic scientific forums
Cross-functional Collaboration: Act as a senior medical-scientific consultant to internal stakeholders, including commercial brand teams, regulatory affairs, market access, business development, other
Facilitate alignment across functions to ensure medical-scientific integrity

What we offer

A fast-paced environment with broad exposure, where you can grow—even beyond your area of expertise
A culture that supports continuous learning, celebrates success, and recognizes performance
Opportunities for driven, talented professionals who want to be part of our ambitious, purpose-led journey

Medical Director, Oncology

During the last five years, Parexel has participated in more than 1,000 Oncology...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Medically qualified based on successful completion of training at an accredited medical school
US or Canada Board-certified in Oncology with experience in adult or pediatric clinical patient care
Excellent interpersonal skills
Excellent time management skills
Excellent verbal and written medical communication skills
Excellent standard of written and spoken English
A flexible attitude with respect to work assignments and new learning
The ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
A willingness to work in a matrix environment and to value the importance of teamwork
The ability to travel 10% domestically and/or internationally as needed

Job Responsibility

Provide medical monitoring for assigned projects
Function as medical representative on the project team
Provide medical consultation as required or requested to client/sponsor or to other Parexel service groups
Assume the role of Senior Technical Lead in selected circumstances
Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness
Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor
Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate
Review documents written by various Parexel divisions for safety issues
Review coding of adverse events and concomitant medications for accuracy and consistency
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents

Associate Director, Integrated Pharmacovigilance Operations

Reporting to the Senior Director, Pharmacovigilance Operations, the Associate Di...

Location

United States , Waltham, Massachusetts; San Diego, California

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance
Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Thorough understanding of Individual Case Safety Reports (ICSR) processing operations, including working with outsourced vendors and Contract Research Organizations
Demonstrated understanding of safety databases, medical literature, and electronic data capture technology
Working knowledge of validated drug safety databases and MedDRA coding dictionary
Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Kailera
Adept at communicating the pharmacovigilance and safety vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate goals
Bachelor’s degree or equivalent in Public Health, Life Sciences, or other relevant fields is required

Job Responsibility

Ensure compliance with global regulatory guidance and requirements (e.g., ICH, FDA, EMA, MHRA, TGA, etc.) and ICH-GCP/ICH-E2E guidelines to meet all applicable safety reporting requirements
Ensure that Individual Case Safety Reports (ICSR) and queries for assigned products are Reviewed for completeness and accuracy and submitted/distributed per global requirements and applicable SOP
Assist with data reconciliation and support safety signal management and aggregate data review activities
Contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
Support the continuous sponsor oversight of the global safety database and safety vendor activities with appropriate governance implementation
Assist with the development and implementation of innovative technical or procedural solutions to improve pharmacovigilance and safety operational capabilities
Assist in production and revision of pharmacovigilance and safety procedures, clinical trial documents and forms (e.g., IB, protocols, EDC CRF pages, etc.)
Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed
Represent pharmacovigilance and safety on project and study teams. Work closely with cross-functional team members to ensure accurate and efficient safety data collection
Work with quality assurance colleagues to address safety-related GCP/GVP compliance issues and support the implementation of corrective actions

What we offer

comprehensive health coverage
flexible time off
paid holidays
a year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Executive Director, Medicine Development Leader

GSK is seeking a highly skilled Executive Director, Medicine Development Leader ...

Location

United States; United Kingdom , Waltham; London; Stevenage; Collegeville

Salary:

242250.00 - 403750.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree including MD, PhD, PharmD, MBA, MS
Drug development expertise in the global pharmaceutical/biotechnology industry
Filing experience with BLA/NDA/MAA submissions as a core responsibility
Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical and Commercial
Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
Experience building budgets and leading the strategic and budget planning process
Experience the healthcare environment, and access in all major markets

Job Responsibility

Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from proof of clinical activity (POC) to Approval in all major market(s)
Work closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
Work with the functional line Heads supporting RIIRU to select MDT members and lead this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
Leads the cross-functional MDT to: Establish a compelling vision for the medicine and Target Medicine Profile (TMP) which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK’s strategy into asset strategy and actionable plans for multiple areas or functions
Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product’s life cycle
Prioritize and maximize the asset’s development options including developing multiple indications
Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Fulltime

Senior Medical Director / Medical Director, Pharmacovigilance

Beam Therapeutics

Location:
United States , Cambridge, MA

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 24, 2025

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