Senior Director, Clinical Development

About the role

We're seeking a Senior Director, Clinical Development to join our Clinical Development team. This role involves clinical evaluation of potential in-licensing or acquisition opportunities and support for molecules advancing through our discovery platforms.

Responsibilities

• Provide clinical input into Due Diligence teams for evaluating external molecules.
• Contribute clinical input to cross-functional planning for molecules emerging from Insmed's discovery platforms.
• Serve on transition teams for in-licensed, acquired, or partnered molecules.
• Maintain awareness of emerging science, competitive landscapes, and global standards of care.
• Collaborate with Global Clinical Development functions to monitor benefit-risk profiles, manage safety signals, and support regulatory communications.
• Support the design of clinical studies and CDPs meeting global ICH-GCP, ethical, and regulatory standards.
• Partner with external medical experts to support development programs and emerging programs from Insmed's discovery platforms.

Requirements

• MD, MD/PhD, or equivalent medical training with board certification in an internal medicine specialty including immunological disorders.
• At least 7 years of clinical development experience in biotech or pharmaceutical settings, with experience in various modalities including oral small molecules and biologics.
• Experience with combination drug-device development and later-stage programs is a plus.
• Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• Proven ability to lead and influence within cross-functional, matrixed organizations.
• Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.
• Strategic thinking and sound clinical judgment.
• Strong influence and decision-making skills in matrixed environments.
• Excellence in communication and external engagement.
• Ability to navigate ambiguity and make timely, balanced decisions.
• Effective collaboration across global, cross-functional teams.

Qualifications

• Original NDA, MAA, and J-NDA experience is a plus.
• Leadership in the design, execution, and interpretation of global Phase 1-2a clinical programs.
• Experience with combination drug-device development and later-stage programs is a plus.
• Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• Proven ability to lead and influence within cross-functional, matrixed organizations.
• Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.
• Strategic thinking and sound clinical judgment.
• Strong influence and decision-making skills in matrixed environments.
• Excellence in communication and external engagement.
• Ability to navigate ambiguity and make timely, balanced decisions.
• Effective collaboration across global, cross-functional teams.

Skills

• Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• Proven ability to lead and influence within cross-functional, matrixed organizations.
• Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.
• Strategic thinking and sound clinical judgment.
• Strong influence and decision-making skills in matrixed environments.
• Excellence in communication and external engagement.
• Ability to navigate ambiguity and make timely, balanced decisions.
• Effective collaboration across global, cross-functional teams.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide fertility and family-forming benefits, caregiver support, and flexible work schedules. Additionally, we offer a 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance. We also provide access to our Employee Assistance Program (EAP).

Pay

$273,000.00 - $372,000.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected. Travel requirements are approximately 10%.