Clinical Study Physician - Dermatology & GI

Who we are

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

The opportunity

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.

Location: The selected candidate will ideally work a hybrid schedule (2-3 days/week onsite) in either our Parsippany, NJ or West Chester, PA office. However, we may consider remote flexible arrangements where it’s deemed necessary due to a candidate’s location.  If remote, occasional travel into one of our offices will be required on an as-needed basis.

How you’ll spend your day

• 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 monitoring visits at any time during the conduct of the study to provide medical input and protocol oversight.
• Maintains strong medical and scientific reputation with the disease area and has in depth TA expertise
• Ensures clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operati