Clinical Trial Physician

Teva Clinical Trial Physician (CTP) DirectorThe 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.Role ResponsibilitiesServe as a primary source of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilitiesProvides medical and scientific expertise to cross-functional colleaguesDesigns, 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 programsMay lead the CDTContributes 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 TPPAccountable for protocol concept sheet, final protocol and protocol amendmentsEnsure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim cutsServes as the primary medical contact for assigned clinical trials, ensuring protocol adherence and safety oversightAddresses medical inquiries from investigators, regulatory agencies, and internal teams, ensuring consistent application of protocol guidelinesResponsibility for assessment of key safety-related serious AEs in partnership with PVG and oversee narrativeMonitors clinical trial conduct, assessing study population, protocol adherence, data trends, safety data, adverse events (AEs), serious adverse events (SAEs), and emerging safety signalsReview 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 approvalLeads medical data review of trial data, including eligibility criteriaSupports 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 guidanceLeads the analysis of the benefit/risk for protocols in a matrix team environmentMay 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 oversightMaintains strong medical and scientific reputation with the disease area and has in depth TA expertiseEnsure clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating ProceduresPartners cross-functionally with departments such as Regulatory Affairs, CMC, Biostatistics, GCO, in the execution of Clinical Development PlansRepresent Teva at Scientific meetings, advisory boards, KOL interactions and meetings with regulatory agencies, as neededAuthor and/or review abstracts, posters and manuscripts, and present data at scientific meetings, as neededMaintain 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 InternationalYour Skills and ExperienceEducation Required:MD, DO. Immunology Therapeutic area expertise preferred with experience in GI, dermatology and/or rheumatologyExperience 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.Already Working @Teva?Make sure to apply through our internal career site on Twist—your one-stop shop for career developmentTeva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to View email address on click.appcast.io with the nature of your request and your contact information.Important notice to Employment Agencies - Please Read CarefullyTeva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.