Clinical Development Responsibilities (including but not limited to the following) –
Works collaboratively with the Clinical Lead and members of the Clinical Sub-Team to develop clinical deliverables (e.g., clinical plans, protocol, clinical study reports, and clinical components of regulatory submissions).
Collaborates with multifunctional study team (clinical, clinical pharmacology, statistics, clinical operations, regulatory, safety, etc.) to design, conduct and report assigned clinical studies ensuring that all activities are fully aligned with Pfizer SOPs, guidelines and regulatory requirements.
Provides clinical input to all study team deliverables (e.g., monitoring guidelines, analysis plans, etc.).
Collaborates with study management staff to identify, evaluate and select clinical sites and investigators.
Works with study team to ensure high quality of data (e.g., appropriate patient population, adequacy of clinical assessments, etc.), as study is ongoing.
Together with the Clinical Lead is responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety.
Provides clinical input on labeling, responses to regulatory queries, and other maintenance and defense-related activities.
Contributes to the development of publications, abstracts, presentations, and clinical trial data disclosures.
Physician-Clinician Responsibilities (additional responsibilities for Medically qualified clinicians)
Performs and documents regular review of safety data from assigned clinical studies consistent with the Safety Review Plan.
Serve as primary contact with external investigators and internal study team for questions relating to medical aspects of the clinical trial protocol.
MD or equivalent
At least 3 years of experience in the pharmaceutical industry designing and conducting Phase 1-4 clinical trials
Strong teamwork and the ability to work effectively in a matrix environment
Excellent communication skills and proven scientific writing ability
Location: Chennai/Mumbai or Remote.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.