11 дней назад
Senior Director, Clinical Research & Development
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Clinical Research & Development (Biopharmaceutical Clinical Development): Leading clinical input for external molecule evaluations, discovery-stage programs, and in-licensed or partnered assets with an accent on global clinical development, regulatory strategy, and cross-functional leadership. Focus on designing and interpreting Phase 1–2a programs, overseeing clinical execution, and evaluating small-molecule, biologic, and combination drug–device products.
Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of up to 20% is expected.
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Provide clinical input to due diligence assessments of external molecules.
- Contribute to cross-functional planning for molecules emerging from discovery platforms at the late lead optimization stage.
- Serve on transition teams for in-licensed, acquired, or partnered molecules.
- Oversee clinical execution and manage clinical development planning and external engagement.
- Monitor emerging science, competitive landscapes, and global standards of care across relevant disease areas.
Requirements
- MD, MD/PhD, PharmD, or equivalent medical training.
- At least 7 years of clinical development experience in biotechnology or pharmaceutical settings.
- Meaningful drug development experience across oral small molecules and biologics; combination drug–device experience is preferred.
- Original NDA, MAA, and J-NDA experience.
- Experience designing, executing, and interpreting global Phase 1–2a clinical programs, including later-stage programs.
- Strong understanding of FDA, EMA, and PMDA regulatory pathways, with the ability to lead within cross-functional matrixed organizations.
Nice to have
- Board certification in an internal medicine specialty.
- Experience with combination drug–device development.
Culture & Benefits
- Medical, dental, and vision coverage with mental health support.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, LinkedIn Learning, workshops, mentorship, networking, employee resource groups, and service opportunities.
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