11 дней назад
Senior Director, Clinical Development
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Clinical Development (Biopharmaceutical Clinical Development): Providing clinical input for external molecules, discovery-platform programs, and in-licensed or acquired assets with an accent on global Phase 1–2a development, benefit–risk assessment, and regulatory strategy. Focus on designing Clinical Development Plans, monitoring safety signals, navigating FDA, EMA, and PMDA pathways, and leading cross-functional clinical programs.
Location: Fully remote and can be performed from anywhere; occasional domestic and international travel of approximately 10% 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 external molecule assessments and due diligence teams.
- Contribute to cross-functional planning for molecules emerging from discovery platforms at the late lead optimization stage.
- Support transition teams for in-licensed, acquired, or partnered molecules.
- Monitor benefit–risk profiles, safety signals, global standards of care, and regulatory communications.
- Support the design of clinical studies and Clinical Development Plans aligned with global ICH-GCP, ethical, and regulatory standards.
- Build partnerships with external medical experts and collaborate across global clinical development functions.
Requirements
- MD, MD/PhD, or equivalent medical training, with board certification in an internal medicine specialty involving immunological disorders, such as rheumatology or transplantation.
- At least 7 years of clinical development experience in biotechnology or pharmaceutical settings.
- Meaningful drug development experience across modalities, including oral small molecules and biologics.
- Leadership experience designing, executing, and interpreting global Phase 1–2a clinical programs.
- Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
- Ability to lead and influence effectively in cross-functional, matrixed organizations with strong scientific judgment and communication skills.
Nice to have
- Experience with combination drug–device products and later-stage programs.
- Original NDA, MAA, and J-NDA experience.
Culture & Benefits
- Fully remote work with purposeful in-person collaboration and team connectivity.
- Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) plan with company match, equity awards, ESPP, and company-paid life and disability insurance.
- Learning and development resources, mentorship, networking, employee resource groups, and service programs.
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