Medical Director Job at Pfizer, USA
Are you ready to lead global clinical trials and drive medical innovation? This Clinical Development Medical Director role offers a high-impact opportunity to work on complex global clinical studies. You will ensure medical and scientific integrity while safeguarding patient well-being. The Medical Director Job at Pfizer Careers in the USA involves designing, executing, and interpreting clinical trials at scale. With leadership responsibilities and global collaboration, this role is ideal for experienced medical professionals. Join a leading pharmaceutical company to shape the future of medicine.
About Pfizer:
Pfizer is a global leader in biopharmaceutical innovation, committed to delivering breakthroughs that change patients’ lives. Through its strong Research & Development division, Pfizer develops life-saving medicines and vaccines. The company focuses on innovation, collaboration, and improving global health outcomes while offering a supportive and growth-oriented work environment.
Job Details:
- Job Title: Director, Clinical Development Medical Director
- Job ID: 4953768
- Job Type: Full-Time
- Locations: La Jolla, Cambridge, Groton, Collegeville, New York City, Herzliya
- Work Model: Hybrid (2.5 days on-site/week)
- Salary Range: $239,900 – $399,800 annually + bonus + incentives
- Travel: Global travel may be required
Job Summary:
- Is accountable for the medical & scientific integrity of the study and the well-being of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high-quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence.
- Is responsible for the effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. The Clinical Development Medical Director is accountable for the timely delivery of a quality protocol, clinical execution of one or more large and/or complex clinical trials, and supports appropriate interpretation and communication of clinical trial data.
- Maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical/medical issues through timely, diligent clinical data, safety, and protocol deviation review. Performs medical monitoring of one or more clinical trials.
- Will be the primary contact with external investigators & the internal study team for questions related to clinical/medical aspects of the protocol, and will partner with/supports the Global Development Lead on study and disease area strategy.
- May also provide matrix management support of one or more R&D Internal Medicine clinicians on one or more clinical studies or across a clinical program.
Medical Director Job Responsibilities:
- Performs medical monitoring on one or more clinical trials:
- Provides study-related medical information and assistance, e.g., on:
- medical questions from investigators, site personnel and non-study health care providers
- safety findings, medical issues, and complex, serious adverse events
- audits or inspection of medical responses
- Contributes to the final significant quality event medical assessments.
- Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.
- Reviews required safety text and endorses significant medical changes in the Informed Consent Document.
- Autonomously and independently leads clinical execution of one or more studies of medium – high complexity and significant business impact. May be accountable for program level clinical deliverables.
- Provides clinical/medical input to support development of the protocol design document (PDD).
- Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/ supports the Global Development Lead in governance review and approval process.
- Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Provides clinical/medical input to the development of data collection tools. Responsible for providing clinical/medical input to SAP, TLFs and BDR.
- Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
- Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
- Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
- Inputs to, reviews, and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any risk mitigations.
- Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
- Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol
- Reviews, reports and manages protocol deviations.
- Reviews patient level and cumulative data per the data review plan across one or more studies.
- Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (eg ICD) are updated as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
- Acts as the medical monitor on one or more clinical trials.
- Ensures TMF compliance for clinical documents
- Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.
- Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection
- May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses) if required.
- May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs)
- Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
- May provide matrix management support to one or more clinical colleagues.
Basic Qualifications:
- As medically qualified individual, the successful candidate must have the following qualifications:
- Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has a minimum of 4-years Clinical Development experience in industry/CRO.
- Been licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period.
- Clinical research experience in phase 3/pivotal space
- Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- Demonstrated clinical/medical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English, in relating to individuals both inside and outside Pfizer
- Demonstrated experience establishing, managing, and training teams in clinical development
Qualifications Preferred:
- Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority preferred.
- Cardiometabolic disease experience highly preferred (ie; cardiology, obesity, endocrinology, nephrology, etc).
- 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.
Benefits of the Medical Director Job:
- High-paying leadership role with global exposure
- Performance-based bonus (25%) and long-term incentives
- Comprehensive healthcare (medical, dental, vision)
- Retirement benefits including 401(k) with company contributions
- Paid vacation, holidays, parental and medical leave
- Opportunity to work on breakthrough clinical innovations
- Career growth within a leading global pharmaceutical company
- Relocation assistance (based on eligibility)
- Inclusive, diverse, and collaborative work culture
