1 час назад
Senior Director, Clinical Development (Biotech)
273 000 - 372 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Clinical Development (Biotech): Leading clinical evaluation of in-licensing and acquisition opportunities and advancing immunological drug programs with an accent on due diligence, early clinical development, and cross-functional collaboration. Focus on designing global Phase 1–2a programs, assessing benefit–risk profiles, navigating FDA, EMA, and PMDA pathways, and supporting transitions of acquired or partnered assets.
Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 10% is expected.
Salary: $273,000–$372,000 annually.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Provide clinical evaluation of potential in-licensing and acquisition opportunities as a member of due diligence teams.
- Contribute clinical input to cross-functional planning for molecules emerging from discovery platforms after the Late Lead Optimization stage.
- Support transition teams for molecules that are in-licensed, acquired, or partnered.
- Monitor benefit–risk profiles, safety signals, and regulatory communications for transitioning assets.
- Support the design of clinical studies and Clinical Development Plans meeting ICH-GCP, ethical, and regulatory standards.
- Build partnerships with external medical experts and maintain awareness of emerging science, competitive landscapes, and standards of care.
Requirements
- MD, MD/PhD, or equivalent medical training required.
- Board certification in an internal medicine specialty covering immunological disorders, such as Rheumatology or Transplantation.
- At least 7 years of clinical development experience in biotech or pharmaceutical settings.
- Experience with drug development across modalities, including oral small molecules and biologics; combination drug–device experience is preferred.
- Leadership experience designing, executing, and interpreting global Phase 1–2a clinical programs.
- Strong understanding of FDA, EMA, and PMDA regulatory pathways, with the ability to influence cross-functional and executive stakeholders.
Nice to have
- Experience with combination drug–device development and later-stage programs.
- Original NDA, MAA, and J-NDA experience.
Culture & Benefits
- Fully remote work with connection to the team and community.
- Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and EAP access.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, mentorship, networking opportunities, employee resource groups, and service initiatives.
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