2 дня назад
Executive Medical Director, Clinical Development
322 000 - 415 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive Medical Director, Clinical Development (Biotechnology): Leading clinical strategy, trial design, medical oversight, and regulatory submissions for autoimmune and inflammatory disease therapies with an accent on Phase I–IV development, patient safety, and scientific rigor. Focus on directing cross-functional programs, preparing FDA and EMA interactions, evaluating clinical data, and advancing pipeline assets toward regulatory approval.
Location: Boston, Massachusetts, United States; hybrid schedule with a minimum of two on-site days per week, currently Tuesday and Wednesday
Salary: $322,000–$415,000 USD per year, with a discretionary annual bonus and potential long-term incentive award.
Company
is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.
What you will do
- Lead clinical strategy, development plans, and medical decision-making for assigned pipeline assets from Phase I through Phase III/IV.
- Design and review clinical trial protocols, informed consent documents, investigator brochures, and clinical sections of regulatory submissions.
- Provide medical oversight, including safety monitoring, serious adverse event review, protocol deviation assessment, and benefit-risk evaluation.
- Lead FDA and EMA interactions, briefing documents, and responses to health authority questions.
- Direct cross-functional program teams across clinical operations, regulatory affairs, translational medicine, biostatistics, and medical affairs.
- Support publications, congress presentations, medical education, business development, and in-licensing evaluations.
Requirements
- Medical degree (MD or DO) required; relevant board certification and clinical fellowship training preferred.
- 5–7 years of clinical development experience within the life sciences industry.
- Experience serving as a physician medical lead across multiple clinical development phases, including regulatory submissions and agency interactions.
- Expertise in clinical trial design, protocol development, GCP compliance, clinical data interpretation, safety monitoring, and pharmacovigilance.
- Knowledge of FDA, EMA, and ICH regulatory frameworks, biostatistics, clinical endpoints, adaptive trial design, and translational biomarker strategies.
- Strong leadership, scientific communication, clinical documentation, and cross-functional collaboration skills.
Culture & Benefits
- Hybrid work arrangement with regular on-site collaboration.
- Health and wellness coverage tailored to the hiring country or region.
- Paid time off, public holidays, and additional leave according to local requirements.
- Inclusive environment focused on scientific excellence, mentoring, and continuous learning.
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