7 дней назад
Senior Medical Director, Clinical Development (Autoimmune and Inflammatory Diseases)
293 000 - 379 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Medical Director, Clinical Development (Autoimmune and Inflammatory Diseases): Leading clinical development strategies and Phase I–III programs for precision therapies targeting autoimmune and inflammatory diseases with an accent on medical oversight, trial design, regulatory submissions, and cross-functional program leadership. Focus on evaluating safety and benefit-risk, guiding FDA and EMA interactions, managing complex multinational programs, and shaping portfolio-level decisions.
Location: Hybrid in Boston, Massachusetts, with at least two on-site days per week, currently Tuesday and Wednesday. Additional on-site attendance may be required based on business needs.
Salary: $293,000–$379,500 per year, with a potential discretionary annual bonus and 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 development strategies, integrated development plans, and medical decision-making for assigned pipeline assets across Phase I–III.
- Design, author, and review clinical protocols, investigator brochures, informed consent documents, and clinical sections of regulatory submissions.
- Provide medical oversight of clinical trials, including safety monitoring, SAE assessment, protocol deviation review, and benefit-risk evaluation.
- Represent assigned programs in FDA and EMA interactions, prepare briefing documents, and respond to health authority questions.
- Direct cross-functional clinical program teams across Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, Pharmacovigilance, and Medical Affairs.
- Build relationships with key opinion leaders, principal investigators, and academic medical centers while mentoring junior physicians and contributing to portfolio decisions.
Requirements
- MD or DO required; board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty is strongly preferred.
- At least 10 years of combined clinical and pharmaceutical or biotechnology industry experience, including preferably 5 years in clinical development.
- Deep expertise in autoimmune disease, immunology, and inflammation; rheumatology experience is preferred.
- Experience leading Phase I–III clinical programs, including protocol development, medical monitoring, and regulatory submissions.
- Ability to identify and mitigate clinical, operational, and regulatory risks across multinational clinical programs.
- Strong scientific communication, leadership, and clinical document authoring skills, including protocols, clinical study reports, regulatory briefing documents, and manuscripts.
Nice to have
- Additional advanced degree such as a PhD, MPH, or MBA.
- Experience leading first-in-human studies, proof-of-concept readouts, pivotal trial initiation, and regulatory submissions.
Culture & Benefits
- Hybrid work arrangement with flexible scheduling.
- Health and wellness coverage, with structure and premiums varying by country.
- Paid time off, public holidays, and additional leave according to local requirements.
- Opportunity to work in a growth-stage biotechnology environment focused on autoimmune and inflammatory disease therapies.
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