Clinical Trial Physician

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.

About the role

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, and pharmacovigilance. The Director will be a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will foster relationships within CDT and with opinion leaders in assigned Therapeutic area. This role is 2-3 days hybrid in our Parsippany, NJ or West Chester, PA sites.

Responsibilities

• 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.
• Manage Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities.
• Provide medical and scientific expertise to cross-functional colleagues.
• Design, conduct, and report clinical trials in line with the development, regulatory, and global program strategy.
• Provide medical expertise in study design, protocol development, and execution, collaborating with cross-functional teams to advance clinical programs.
• May lead the CDT.
• Contribute to and support 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.
• Serve as the primary medical contact for assigned clinical trials, ensuring protocol adherence and safety oversight.
• Address 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.
• Monitor 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.
• Lead medical data review of trial data, including eligibility criteria.
• Support Global Clinical Operations in clinical trial initiation, resource planning, study implementation, and successful completion of study, including database lock and interim cuts.
• Support site selection, patient recruitment, and investigator engagement through regular interactions and guidance.
• Lead the analysis of the benefit/risk for protocols in a matrix team environment.
• Prepare presentations and present at relevant internal or external venues such as Investigator Meetings, independent data monitoring committees, protocol review committees, etc.
• 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.
• Maintain a strong medical and scientific reputation within the disease area and have in-depth therapeutic area (TA) expertise.
• Ensure clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating Procedures.
• Partner cross-functionally with departments such as Regulatory Affairs, CMC, Biostatistics, GCO, in the execution of Clinical Development Plans.
• Represent Teva at scientific meetings, advisory boards, KOL interactions, and meetings with regulatory agencies, as needed.
• Author and/or review abstracts, posters, and manuscripts, and present data at scientific meetings, as needed.
• Maintain or establish interaction with external scientific and clinical communities and incorporate pertinent advice and learnings into the internal program.

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

Requirements

• MD, DO.
• Immunology Therapeutic area expertise preferred with experience in GI, dermatology, and/or rheumatology.
• At least 3 years in a pharmaceutical industry, CRO, or other health-related scientific field; planning/managing clinical trials or with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge.
• Knowledge of regulatory requirements governing clinical trials and experience in the design and successful execution of clinical trials.
• May have performed protocol design in the academic environment and/or acted as an assistant Principal Investigator or Principal Investigator.
• May have been an FDA reviewer for disease area.

Skills

• Excellent interpersonal, verbal, and written scientific communication skills (English).
• Ability to manage multiple conflicting priorities and varied concurrent tasks.
• Strong sense of urgency and understanding of time pressures, ability to thrive and enjoy working independently in a fast-paced, multi-tasking environment.
• Ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena.

Pay

The annual starting salary for this position is between $231,520 – $289,400 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave (if eligible), Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance, and Long Term Disability.