Clinical Study Physician

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The Clinical Trial Physician (CTP), Director, sits within Clinical Development and is responsible for contributing to the design and implementation of the clinical development plan, working closely with Disease Area Head, Clinical Development Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory, pharmacovigilance. The Director will be a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications.

The Director will foster relationships with opinion leaders in assigned therapeutic area. The CTP is a member of the study team and CDT.

The CTP is expected to advance scientific and clinical knowledge, incorporate new methodologies, and pro-actively progress study execution.

The role of CTP:

• Serve as a primary source of medical accountability and oversight for one or more clinical trials
• Matrix management responsibilities across the internal and external network
• Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities
• Provides medical and scientific expertise to cross-functional colleagues

Travel Requirements:
Approximately 20%, both domestic and International.

This role can be based in the Parsippany, NJ or the West Chester, PA office.

• Designs, conducts, and reports clinical trials in line with the development, regulatory and global program strategy. Provides medical expertise in study design, protocol development, and execution, collaborating with cross-functional teams to advance clinical programs.
• Contributes to and supports the development and execution of the CDP in collaboration with the CDL or DAH, including clinical development strategy from early development through to approval phase, sections of the IDP and TPP
• Accountable for protocol concept sheet, final protocol and protocol amendments.
• Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts.
• Serves as the primary medical contact for assigned clinical trials, ensuring protocol adherence and safety oversight
• Addresses medical inquiries from investigators, regulatory agencies, and internal teams, ensuring consistent application of protocol guidelines.
• Responsibility for assessment of key safety-related serious Aes in partnership with PVG and oversee narrative
• Monitors clinical trial conduct, assessing study population, protocol adherence, data trends, safety data, adverse events (AEs), serious adverse events (SAEs), and emerging safety signals.
• Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.
• Leads medical data review of trial data, including eligibilty criteria
• Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion of study, including database lock and interim cuts. Supports site selection, patient recruitment, and investigator engagement through regular interactions and guidance.
• Leads the analysis of the benefit/risk for protocols in a matrix team environment
• Makes presentations at the Investigator Meetings and other relevant internal or external venues such as data monitoring and protocol review committees
• May participate in Site Initiation Visit (SIV) and conduct medical…