Our Team, Your ImpactThe 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 within CDT and with opinion leaders in assigned Therapeutic area. CTP is a member of the study team and CDT.
CTP is expected to advance scientific and clinical knowledge, incorporate new methodologies, and pro-actively progress study execution.
This role is 2-3 days hybrid in our Parsippany, NJ or West Chester, PA sites.
How You'll Spend Your DayThe 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
- 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
- May lead the CDT
- 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 eligibility 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
- May prepare presentations and presents 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
- Maintains strong medical and scientific reputation with the disease area and has in depth 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
- Partners 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
Your Skills and ExperienceEducation Required:- MD, DO. Immunology Therapeutic area expertise preferred with experience in GI, dermatology and/or rheumatology
Experience Required:- 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 a FDA reviewer for disease area.
Job-Specific Competencies:- 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.
Salary RangeThe 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.
How We'll Take Care of YouWe offer a competitive benefits package, including:
- 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 and more.
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