Senior Director, Clinical Research & Development
Insmed Incorporated
6 hours ago
Remote
United States
$273,000 - $372,000 USD yearly
Clinical Research and Development
Senior Director, Clinical Research & Development (Clinical Development)
Responsibilities
- Provide clinical evaluation of potential in-licensing or acquisition opportunities (coordinated and led by Business Development).
- Support cross-functional discussions with Insmed discovery research platforms as molecules advance beyond the Late Lead Optimization milestone.
- Provide clinical input to the overall assessment of external molecules as part of Due Diligence teams.
- Contribute clinical input to cross-functional planning for molecules emerging from Insmed discovery platforms at the Late Lead Optimization stage.
- Serve on transition teams for molecules that are in-licensed, acquired, or partnered (as needed).
- Oversee clinical execution, and manage clinical development planning and external engagement.
- Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas.
Qualifications
- MD, MD/PhD, PharmD, or equivalent medical training.
- Board certification in an internal medicine specialty (preferred).
- At least 7 years of clinical development experience in biotech or pharmaceutical settings.
- Meaningful drug development experience across modalities (including oral small molecules and biologics).
- Experience with combination drug–device products (preferred).
- Original NDA, MAA, and J-NDA experience.
Additional Skills/Experience
- Leadership in design, execution, and interpretation of global Phase 1–2a clinical programs.
- Experience with combination drug–device development and later-stage 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.
- Excellent written and verbal communication skills; ability to engage scientific, regulatory, and executive stakeholders.
Work Location / Travel
- Fully remote role.
- Occasional travel for team meetings or events; up to 20% domestic/international.
Pay Range
- $273,000.00–372,000.00 annual
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities
- Provide clinical evaluation of potential in-licensing or acquisition opportunities (coordinated and led by Business Development).
- Support cross-functional discussions with Insmed discovery research platforms as molecules advance beyond the Late Lead Optimization milestone.
- Provide clinical input to the overall assessment of external molecules as part of Due Diligence teams.
- Contribute clinical input to cross-functional planning for molecules emerging from Insmed discovery platforms at the Late Lead Optimization stage.
- Serve on transition teams for molecules that are in-licensed, acquired, or partnered (as needed).
- Oversee clinical execution, and manage clinical development planning and external engagement.
- Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas.
Qualifications
- MD, MD/PhD, PharmD, or equivalent medical training.
- Board certification in an internal medicine specialty (preferred).
- At least 7 years of clinical development experience in biotech or pharmaceutical settings.
- Meaningful drug development experience across modalities (including oral small molecules and biologics).
- Experience with combination drug–device products (preferred).
- Original NDA, MAA, and J-NDA experience.
Additional Skills/Experience
- Leadership in design, execution, and interpretation of global Phase 1–2a clinical programs.
- Experience with combination drug–device development and later-stage 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.
- Excellent written and verbal communication skills; ability to engage scientific, regulatory, and executive stakeholders.
Work Location / Travel
- Fully remote role.
- Occasional travel for team meetings or events; up to 20% domestic/international.
Pay Range
- $273,000.00–372,000.00 annual
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.