Clinical Development Medical Senior Director (MD Required)
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Описание вакансии
TL;DR
Clinical Development Medical Senior Director (MD Required) (Clinical Research/Drug Development): Providing medical and scientific oversight for Internal Medicine clinical trials, with an accent on clinical deliverables, data integrity, safety review, and regulatory collaboration. Focus on designing and executing complex studies, leading cross-functional teams, managing emerging clinical data and safety risks, and supporting global regulatory interactions.
Location: Hybrid role based in Collegeville, Pennsylvania, requiring residence within commuting distance and on-site work an average of 2.5 days per week. Candidates must have permanent U.S. work authorization; visa sponsorship is not available. Global travel may be required. Relocation assistance may be available based on eligibility and business needs.
Salary: $274,500–$457,500 annual base salary, plus a 25% bonus target and eligibility for a share-based long-term incentive program.
Company
is a global pharmaceutical company developing medicines and vaccines across a broad range of therapeutic areas.
What you will do
- Provide medical monitoring and scientific oversight for one or more clinical trials, including investigator guidance, data review, quality events, and safety assessments.
- Lead clinical execution and deliverables across study design, start-up, conduct, close-out, reporting, and regulatory submissions.
- Develop and review protocols, informed consent documents, statistical analysis plans, clinical data strategies, safety plans, and risk management plans.
- Establish and manage external data monitoring and adjudication committees, including charters, data presentations, and recommendations.
- Serve as the primary clinical contact for investigators and study teams, supporting protocol training, data issue resolution, and deviation management.
- Support audits, inspections, clinical study reports, safety and efficacy disclosures, publications, and continuous improvement initiatives while mentoring clinical colleagues.
Requirements
- MD, DO, MBBS, MBChB, or another recognized primary medical degree is required.
- At least 7 years of biopharmaceutical industry experience in clinical research and development.
- At least 2 years of independent prescribing licensure after internship, house officer, or foundation training.
- Permanent U.S. work authorization is required; U.S. work visa sponsorship is not available now or in the future.
- Strong knowledge of clinical development, global and regional regulations, ICH/GCP, clinical data review, safety management, and regulatory processes.
- Leadership experience with cross-functional clinical teams, mentoring, coaching, prioritization, conflict resolution, and delivery of complex projects.
Nice to have
- Experience in cardiometabolic diseases such as obesity, diabetes, or endocrinology.
- Experience with clinical study design, regulatory submissions, inspections, and pharmaceutical development.
- Scientific publications, posters, abstracts, or presentations.
- Experience launching, managing, and training clinical development teams.
Culture & Benefits
- Comprehensive medical, prescription drug, dental, and vision coverage.
- 401(k) plan with company matching and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
- Participation in the Global Performance Plan with a 25% bonus target.
- Eligibility for a share-based long-term incentive program.
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