Director, Clinical Development Medical Director United States - New York - Pearl River United States - Pennsylvania - Collegeville Direct and oversee the medical monitoring, safety, and clinical strategy of clinical trials to support the development of new compounds. Responsibilities Accountable for safety across the study Provide medical advice for all medical issues during risk assessment and mitigation planning. Ensure development and adherence to the Safety Surveillance Review Plan (SSRP). Perform regular review of individual and cumulative safety data. Delegate responsibilities to the study clinician scientist per SSRP. Monitor study safety issues and contribute to serious adverse event (SAE) reporting. Provide medical context for SAEs/AE for benefit‑risk assessments. Participate in the Safety Review Team and review literature as needed. Communicate safety information to sites. Protocol design and strategy Provide medical input during development and updates to the clinical development plan. Design clinical studies to meet objectives aligned with the clinical program strategy. Ensure protocol, informed consent documents and other documents meet regulatory requirements and have been reviewed by IRB/IECs. Provide medical input into country feasibility. Support study team Offer clinical input for monitoring guidelines, statistical analysis plans, data checks, and data quality planning. Contribute to CRO/vendor selection. Ensure high‑quality data and adequate clinical assessments. Conduct medical review and interpretation of efficacy and safety data, collaborating with statistician, medical writer. Ensure medical and scientific validity of study reports. Disclose safety and efficacy data (ClinicalTrials.gov, etc.). Provide protocol specific training to study team. Interact with healthcare professionals at sites and with DMCs/steering committees. Notify team of changes in research activity and significant adverse events. Monitor investigator compliance with protocol and regulatory requirements. Support study team with issue resolution, close‑out, audit responses, inspection readiness. Supports the program team Author clinical sections of regulatory documents. Co‑author abstracts, posters, presentations and publications. Contribute to budget execution of protocols. Interact with regulatory authorities, key opinion leaders, and principal investigators Support interactions with Clinical Regulatory Authorities. Liaise with Key Opinion Leaders and Principal Investigators to build networks for new trials. Basic Qualifications Medical degree (M.D./D.O. or equivalent). 4+ years of work experience. Licensed to prescribe medicines independently for at least two years and at least one year of patient‑care prescribing. Ability to critically evaluate medical/scientific information. Understands design, development, and execution of clinical programs and studies. Documented experience in the pharmaceutical industry related to clinical research and registration activities. Experience managing multiple studies. Preferred Qualifications Experience with statistics. Training and experience in infectious diseases and/or infection control in a hospital setting. Experience with investigational clinical trials. Excellent written and oral communication skills. Capacity to adapt to a fast‑paced and changing environment. Demonstrated diverse leadership experience, influencing and collaborating with peers, developing and coaching others, and guiding colleagues to achieve meaningful outcomes. Compensation and Benefits The annual base salary ranges from $239,900.00 to $399,800.00. Eligibility for Pfizer’s Global Performance Plan with a bonus target of 25.0% of base salary and participation in the share‑based long‑term incentive program. Benefits include a 401(k) plan with matching contributions, additional retirement savings contribution, paid vacation, holidays, personal days, paid caregiver/parental leave, and health benefits (medical, prescription drug, dental, vision). Relocation & Work Status Relocation support may be available based on business needs. Work location assignment: Hybrid. Sunshine Act Pfizer reports payments and other transfers of value to healthcare providers as required by federal and state transparency laws. Reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the Sunshine Act. If you are a licensed physician, please contact our Talent Acquisition representative with any questions. EEO & Employment Eligibility Pfizer is committed to equal opportunity in employment. This position requires permanent work authorization in the United States and is an E‑Verify employer. No U.S. work visa sponsorship (TN, O‑1, H‑1B, etc.) is available for this role now or in the future. #J-18808-Ljbffr
Director, Clinical Development Medical Director
PFIZER, S.A. DE C.V
pearl river, pearl river
Published 4 days ago
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