Senior Director, Clinical Development (Biotech)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
TL;DR
Senior Director, Clinical Development (Biotech): Leading clinical evaluation of in-licensing and acquisition opportunities and supporting cross-functional discovery research platforms with an accent on immunological disorders. Focus on designing clinical development plans, managing benefit-risk profiles, and engaging external medical experts to advance molecules from late lead optimization.
Location: Fully remote within the United States
Salary: $273,000β$372,000 Annual
Company
is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.
What you will do
- Provide clinical input for due diligence teams assessing external molecules for acquisition or in-licensing.
- Contribute to cross-functional planning for molecules emerging from discovery platforms at the late lead optimization stage.
- Collaborate with global clinical development functions to design clinical studies and development plans meeting regulatory standards.
- Monitor benefit-risk profiles and manage safety signals for in-licensed or acquired assets.
- Build and maintain partnerships with external medical experts to support development programs.
- Serve on transition teams for newly acquired or partnered molecules.
Requirements
- MD, MD/PhD, or equivalent medical training required.
- Board certification in an internal medicine specialty including immunological disorders (e.g., Rheumatology or Transplantation).
- Minimum 7 years of clinical development experience in biotech or pharmaceutical settings.
- Experience with oral small molecules and biologics.
- Strong understanding of global regulatory pathways (FDA, EMA, PMDA).
- Ability to travel approximately 10% for domestic and international meetings.
Nice to have
- Experience with combination drug-device products.
- Original NDA, MAA, and J-NDA submission experience.
- Leadership experience in Phase 1β2a clinical programs.
Culture & Benefits
- Comprehensive medical, dental, and vision coverage with mental health support.
- 401(k) plan with company match and annual equity awards.
- Generous paid time off and flexible work schedules.
- Access to the Company Learning Institute for professional development.
- Employee resource groups and service programs.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β