Director, Clinical Development Medical Director

ROLE SUMMARY The Clinician Medical Monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in‑licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile.

ROLE RESPONSIBILITIES Accountable for safety across the study Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP). Perform and document regular review of individual subject safety data and review of cumulative safety data with the safety risk lead.

Delegate responsibilities to the study clinician scientist identified in the SSRP when appropriate. Review safety data according to the Safety Data Review Guide – for Clinicians and other SOPs. Monitor study safety issues and provide input to serious adverse events (SAEs) reports.

Provide medical context for risk factors, medical history and other factors required to assess SAEs or AEs for benefit‑risk evaluations. Participate in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Review literature as needed to respond to safety questions from the Safety Review Team, DMC or other stakeholders.

Communicate safety information to sites and address questions. Protocol design and strategy Provide medical input during development and updates to the clinical development plan. Design clinical studies to meet stated objectives and align with the clinical program strategy.

Ensure protocol, Informed Consent Document (ICD) and related documents meet regulatory requirements, company policy and have been reviewed by IRB/IECs. Provide medical input into country feasibility. Support study team Provide clinical input to protocol/study team for monitoring guidelines, statistical analysis plans, ICDs, clinical review forms, data edit checks and data quality planning.

Contribute to contract research organization/vendor selection to ensure compliance with protocol requirements and study timelines. Work with study team to ensure high‑quality data, appropriate patient population and adequate clinical assessments. Conduct medical review and interpretation of efficacy and safety data from clinical trials, facilitating delivery of top‑line reports and clinical study reports with statisticians and medical writers.

Ensure medical and scientific validity of study reports, especially conclusions regarding efficacy and safety. Disclose safety and efficacy data on ClinicalTrials.gov, EudraCT or Pfizer.com. Provide protocol‑specific training to study team, investigators, clinical research associates and others.

Interact with healthcare professionals at sites, leveraging RMMs when assigned. Interact with DMCs and steering committees as required. Notify study team of changes in research activity and significant new adverse events.

Monitor investigator compliance with protocol and regulatory requirements. Support study team in issue resolution, study closeout, audit responses and inspection readiness. Supports the program team Author clinical sections of regulatory documents (Investigator Brochure, Annual Reports, IND sections, clinical study reports).

Co‑author abstracts, posters, presentations and publications when appropriate. Contribute to budget execution of protocols. Interact with regulatory authorities, key opinion leaders and principal investigators Support Clinical Regulatory Authority interactions and provide responses.

Liaise with Key Opinion Leaders and Principal Investigators in countries to build a network for new trials. BASIC QUALIFICATIONS Medical degree (M.D./D.O. or equivalent). 4+ years of work experience. Licensed by a health authority to prescribe medicines (independent of supervision) for at least two years and with at least one year of patient‑care prescribing experience.

Ability to critically evaluate medical/scientific information. Understanding of the design, development and execution of clinical programs and studies. Documented experience in the pharmaceutical industry related to clinical research programs and registration activities.

Experience managing multiple studies. PREFERRED QUALIFICATIONS Experience or knowledge of statistics. Training and experience in infectious diseases and/or infection control in the hospital setting.

Experience with investigational clinical trials. Excellent written and oral communication skills. Capacity to adapt to a fast pace and changing environment.

Leadership experience: influencing and collaborating with peers, developing and coaching others, and guiding colleagues to achieve meaningful outcomes and business impact. Relocation support available. Work Location Assignment: Hybrid.

Candidate must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O‑1, H‑1B, etc.) is not available for this role now or in the future. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws.

If you are a licensed physician who incurs recruiting expenses paid or reimbursed by Pfizer, the amount will be reported to the government. Contact your Talent Acquisition representative for questions. EEO & Employment Eligibility Pfizer is committed to equal opportunity in employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability or veteran status.

Pfizer complies with all applicable nondiscrimination laws and work‑authorization requirements. Pfizer is an E‑Verify employer. This position requires permanent U.S. work authorization.

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