3 часа назад
Senior Medical Director Clinical Development Neuroscience (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Medical Director Clinical Development Neuroscience (Biotech): Leading clinical development programs for neuromuscular and neurodegenerative diseases with an accent on Phase I/II/III trial design, patient safety, global regulatory strategy, and clinical filings. Focus on interpreting clinical data, guiding investigators and external experts, preparing IND, CTA, and NDA submissions, and advancing neuroscience therapeutics toward approval.
Location: New Haven, Connecticut headquarters, or hybrid/remote from a location within the United States. Standard business-hours availability is required; duties are generally conducted in a home-office environment.
Company
is a clinical-stage biotechnology company developing PROTAC protein degraders for serious diseases, including neurological and neurodegenerative conditions.
What you will do
- Lead the development, oversight, and execution of neuroscience clinical research programs, including pivotal trials and filing activities.
- Design Phase I, II, and III trials for neurologic diseases and monitor patient safety, efficacy, and clinical data.
- Partner with discovery, biology, clinical operations, regulatory affairs, and external organizations on trial execution and investigator engagement.
- Develop global regulatory plans and support interactions with regulatory agencies and preparation of IND, CTA, and NDA submissions.
- Build relationships with clinical investigators, opinion leaders, regulatory officials, and external experts.
- Interpret clinical trial data and prepare study reports, integrated summaries, regulatory updates, publications, and product labeling.
Requirements
- MD or equivalent degree required.
- At least 5 years of biotech or pharmaceutical experience in neurological disease clinical drug development; 7+ years strongly preferred.
- Experience across multiple clinical development stages, from IND through NDA or BLA, with global clinical development experience required.
- Experience evaluating clinical and scientific opportunities for in-licensing or internal development.
- Experience supervising physicians or scientific staff is highly desirable, along with strong leadership, interpersonal, and public-speaking skills.
- Must be legally authorized to work in the United States without employer sponsorship now or in the future.
Nice to have
- Global filing experience.
- Formal training in Neurology and professional board certification.
Culture & Benefits
- Mission-driven environment focused on developing therapies for serious and debilitating diseases.
- Collaborative, cross-functional, and matrix-based work with opportunities to lead innovative drug development programs.
- Competitive base and incentive compensation.
- Medical, vision, and dental coverage, life insurance, and additional benefits supporting employees and their families.
- Work-from-home flexibility is available for eligible U.S.-based arrangements.
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