PCRU New Haven Medical Director (MD)

The Medical Director of the Pfizer Clinical Research Units (PCRUs) is the single point of accountability for medical and safety oversight of participants at the PCRU and acts as the primary medical provider for the unit. They are highly experienced physicians accountable for the clinical medical and scientific integrity of early phase studies conducted at the PCRU. The role provides medical leadership participant safety oversight clinical decision making and scientific partnership across all studies executed at the Unit. The Medical Director also contributes to protocol development feasibility assessment safety governance and cross functional alignment to ensure operational excellence in early phase clinical research.

1. Clinical Leadership & Medical Governance

Provide overall medical oversight for PCRU studies ensuring participant safety and clinical integrity.

Serve as Principal Investigator (PI) on assigned studies where applicable.

Lead the medical function

2. Study Design & Scientific Partnership

Contribute to study design feasibility assessment and protocol development.

Ensure medical feasibility and ethical soundness of proposed studies.

Collaborate with Clinical Pharmacology ECD Regulatory Drug Safety R&D and TherapeuticAreas.

3. Participant Safety & Clinical Decision Making

Oversee real-time safety monitoring and provide clinical judgment for adverse event management.

In the capacity of PI participatein dose escalation decisions risk assessments and safety review committees.

Support 24/7 medical escalation processes (sharedroster).

4. Operational Excellence & Site Standards

Ensure adherence to ICH/GCP local regulatory requirements and Pfizer SOPs.

Support audits and inspections and lead remediation for medical findings.

Drive improvements in clinical workflows risk management and data integrity.

5. Cross Functional Leadership

Collaborate with Clinical Operations Labs Pharmaceutical Operations Recruitment Data Sciences and Quality.

Participate in Site Leadership Team meetings and contribute to strategic decision making.

In the capacity of PI provide medical oversight of screening pharmacology procedures assessments and study readiness.

6. External Engagement & Representation

Represent Pfizer PCRUs to external investigators ethics bodies and academic partners.

Contribute to scientific publications internal training and innovation initiatives.

Core Responsibilities

Serve as medical lead for all assigned studies ensuring clinical excellence and participant safety.

In the capacity of PI evaluate clinical data including labs ECGs adverse events and safety signals.

Provide medical and scientific oversight during dosing procedures and can be a member of the Medical Emergency Response Team.

Ensure accurate compliant documentation and delegation of medical activities.

Partner with site functions to ensure high-quality execution of Phase 1 studies.

Support harmonization of medical practices across PCRU sites (Brussels and New Haven).

Maintains currency of medical/scientific/technical knowledge pertinent to the position and the evolving drug development portfolio.

Required:

Medical Degree (MD in BR/NH) or equivalent medical degree: Doctor of Osteopathic Medicine DO (NH)

Extensive clinical experience with strong medical decision-making skills.

Ability to interpret complex clinical and laboratory data.

Strong communication and cross functional leadership abilities.

Preferred:

Prior PI or Medical Director experience.

Early phase clinical trial experience.

Understanding of regulatory requirements (FDA EMA AFMPS).

Experience in early phase units hospitals or acute care clinical environments.

Reports to the NH Site Lead.

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.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be on site for PI related duties and call coverage as assigned.

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.

Candidates 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.