Medical Director, Pharmacovigilance Job at Kailera Therapeutics (Waltham)

Senior Medical Director / Medical Director, Pharmacovigilance

The Medical Director of Pharmacovigilance (PV) will provide clinical/scientific/...

Location

United States , Cambridge, MA

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD required, Board certification preferred with 15+ years of experience
5+ years of pharmacovigilance experience
Experience in cell or gene therapy preferred
Experience as safety lead for asset/approved drug product e.g. Global Safety Lead
Oversight experience of global medical safety activities
Demonstrated knowledge of global PV regulatory environment
Working knowledge of industry standard safety databases (ARGUS and ARISg)
Knowledge of MedDRA dictionary
Excellent knowledge of drug development process
Experience reviewing cumulative safety data

Job Responsibility

Provide dynamic leadership, strategic direction and governance of patient safety and PV risk management activities
Lead signal detection and risk management activities for assigned products
Lead proactive and ongoing analysis and interpretation of non-clinical data, clinical, post-marketing, scientific literature
Lead PV during interactions with Regulatory Authorities (RA)
Perform individual case safety report (ICSR) medical review
Lead multidisciplinary Safety Management Committee (SMC) and Executive Safety Committee (ESC)
Serve as PV SME in support of regulatory filing activities
Collaborate with cross functional team
Address internal/external safety-related requests
Provide guidance regarding Statistical Analysis Plans

Fulltime

Medical Director, Clinical Development - Dermatology/Immunology

We are seeking a Medical Director to oversee clinical execution and medical moni...

Location

United States

Salary:

280000.00 - 325000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MD is required
Experience in clinical development within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
2+ years’ industry experience as a medical monitor and/or medical director
Experience working on phase 2 and 3 clinical studies required
Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others
Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability to travel approximately 20% to All Team meetings, functional meetings, study-related activities, and medical conferences

Job Responsibility

Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
Support the design of trials and develop protocols and other relevant documents for individual studies
Support all the start-up activities related to the assigned dermatology clinical study
Oversee day-to-day clinical and medical execution of studies
Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
Partner with clinical operations on site selection, recruitment, and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
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

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

New

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

New

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

SPC Global Medical Director - Ophthalmology

Join the team transforming care for people with immune challenges, rare diseases...

Location

United States , Cambridge, MA / Morristown, NJ

Salary:

178500.00 - 297500.00 USD / Year

Sanofi

Expiration Date

April 01, 2026

Requirements

Advanced degree (MD, PhD, PharmD) required
board certification (or eligible) in ophthalmology highly preferred
Minimum of 3 years of retinal disease expertise
at least 3 years of pharmaceutical/biotechnology industry experience preferred
Demonstrated experience in medical affairs or clinical development roles, including early pipeline management, KOL engagement, and scientific communication
Proven track record at country or global level
US market experience strongly preferred
Broad understanding of the drug development process, regulatory requirements, risk management, health authority interactions, and market access considerations
Expertise in retinal clinical science, therapeutic landscape, and evidence generation methodologies, including clinical trials and real-word evidence
Significant experience working with Research, Clinical Development, Commercial, Health Economic Value & Access teams

Job Responsibility

Serve as the medical representative, providing strategic input and ensuring alignment of ophthalmology medical tactics with overall brand objectives
Participate in cross-functional workstreams to design and implement global medical programs supporting the ophthalmology portfolio
Contribute to the Global Medical Affairs Plan for ophthalmology assets
Collaborate with Scientific Communications to develop high-quality materials for external medical engagement and deliver global medical training programs
Lead and execute global medical activities within the Medical Affairs Plan, including advisory boards, expert meetings, and symposia
Drive evidence generation initiatives (e.g., Investigator-Initiated Studies, Real-World Evidence projects) in line with the Integrated Evidence Generation Plan (IEGP)
Lead strategically assigned projects to advance scientific understanding and clinical application of ophthalmology therapies
Build and maintain strong KOL relationships globally
Ensure cross-functional collaboration with Commercial, Regulatory, Pharmacovigilance, and Market Access teams
review promotional and non-promotional materials in Veeva/PromoMats

What we offer

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave
opportunities for career growth and development
promotion or lateral move opportunities, at home or internationally

Fulltime

Associate Director, Pharmacovigilance Planning and Innovations

Reporting to the Senior Vice President, Patient Safety and Pharmacovigilance, th...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in biotech, pharma or CRO with a demonstrated focus on pharmacovigilance, drug safety, or related field
3+ years of project or program management experience in a regulated environment
Demonstrated project management skills with strong analytical and problem-solving capabilities
Exceptional communication, stakeholder engagement, and change management skills
Strong interpersonal, organizational, and strategic planning skills
Experience working with outsourced vendors or Contract Research Organizations (CROs)
Experience leading or supporting process improvement
Adaptable to changing priorities and across multiple clinical trials and deliverables
Adept at communicating departmental vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate objectives
Proficient computer skills, including Word, PowerPoint, Excel, Visio, Power BI or similar

Job Responsibility

Coordinate and lead departmental planning activities for the PSPV organization including, e.g., headcount modeling, organizational design, and pharmacovigilance projects
Lead end-to-end project management for PV initiatives, including system implementations, process improvements, compliance programs, and organizational change efforts
Develop and maintain project plans, metrics, and dashboards to support PSPV strategies
Support resource forecasting, alliance management, and vendor oversight
Facilitate cross functional meetings, track actions, and ensure on-time execution of project deliverables
Communicate project updates to internal and external stakeholders through clear status reports, presentations, and dashboards
Ensure project outcomes align with PV strategy and broader corporate objectives
Build strong working relationships with cross functional leaders to support a proactive and collaborative safety culture
Manage and coordinate cross functional alignment for operational effectiveness and PV system/process evolution
Develop and maintain the pharmacovigilance innovation roadmap aligned with cross functional initiatives and compliance requirements

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

Medical Director, Pharmacovigilance

Kailera Therapeutics

Location:
United States , Waltham

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

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