Head of Clinical Pharmacology and Pharmacometrics

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

We are seeking an innovative and collaborative Executive Director of Clinical Pharmacology and Pharmacometrics (CPP) to lead and oversee all aspects of clinical pharmacology, pharmacokinetics, and pharmacodynamics to support drug development programs from preclinical to post-marketing stages. Reporting to the Chief Development Officer, this role will provide strategic direction, scientific leadership, and technical expertise in clinical pharmacology while fostering cross-functional collaboration and innovation. The ideal candidate will have significant experience applying model-informed drug development strategies to advance small molecules, and biologics with a strong background in global regulatory interactions, health authority filings, and team leadership.

Responsibilities

Strategic Leadership:

• Oversee the development and implementation of innovative CPP strategies for drug development programs, including dose selection, study design, and lifecycle management.
• Partner with cross-functional teams, including Biostatistics, Clinical Operations, Regulatory, CMC, Clinical, and Translational Biomarkers/Bioanalyticals to align clinical pharmacology objectives with program goals.
• Represent the CPP function at internal forums and in health authority interactions.

Clinical Pharmacology Execution:

• Oversee the design, analyses, and interpretation of PK/PD, exposure-response, population PK, and quantitative modeling to inform decision-making for clinical trials.
• Oversee Clinical Pharmacology aspects of regulatory submissions, including INDs, NDAs, CTAs, and health authority responses.

Regulatory and Compliance:

• Ensure clinical pharmacology strategies and deliverables meet global regulatory requirements.
• Lead preparation of pharmacology components for regulatory documents and participate in regulatory meetings.

Collaboration and Communication:

• Actively participate in cross-functional team meetings and provide expertise in integrating pre-clinical and clinical data.
• Present findings and recommendations to internal partners, senior leadership, and external collaborators.
• Drive external partnerships with CROs, consultants, and academic institutions.

Team Leadership:

• Build, mentor, and lead a high-performing CPP team, encouraging innovation, scientific rigor, and professional development.
• Oversee deliverables of direct reports and external collaborators to maintain high scientific and ethical standards.

Position Requirements :

• PhD or MD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, or related field.
• 10+ years of relevant industry experience in clinical pharmacology/pharmacometrics with demonstrated leadership in advancing drug development programs.
• Strong track record in global regulatory interactions, including successful INDs, NDAs, or CTAs.
• Deep understanding of clinical pharmacology principles and regulatory requiremen