Associate Director, DMPK

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

The Associate Director, DMPK will be accountable for the non-clinical pharmacokinetics and drug metabolism components of drug discovery and development programs at Insmed, including small and large molecules. The Associate Director DMPK is expected to have in-depth DMPK knowledge and hands-on experience and be familiar with pharmaceutical drug discovery and development. This role will work collaboratively with other team members and provide oversight of vendors.

Responsibilities

• Serve as the DMPK lead on assigned project teams, responsible for strategy and execution of non-clinical drug metabolism programs for small and large molecules in Discovery and Development.
• Participate in the design, data analysis, and interpretation of DMPK and non-clinical PK/PD studies.
• Support Toxicokinetic (TK) study design and data interpretation.
• Author DMPK sections of regulatory submissions such as briefing books, INDs, CTAs and NDAs.
• Provide CRO oversight for in vitro and in vivo DMPK studies.
• Work with in-house laboratory to expand DMPK capabilities.
• Closely partner with Research, Toxicology, Clinical Development, Regulatory, Project Management, and other functions.
• Establish human predictions for first-in-human dose selection based on PK and PD predictions and safety multiple assessment.

Position requirements:

• PhD in pharmacokinetics, pharmaceutical sciences, or related scientific field with a minimum of 5 years of biotech/pharmaceutical drug discovery and development experience.
• Expertise with in vitro and in vivo DMPK studies.
• Previous involvement in both drug Discovery and Drug Development programs is a plus.
• Familiarity in development of protein therapeutics, antisense oligonucleotides, and/or gene therapies is a plus.
• Experience vetting and collaborating with CROs on a wide range of studies.
• Ability to plan, organize, and critically assess and perform PK/PD data analyses.
• Hands-on experience with Phoenix WinNonlin, NONMEM, R and/or ADME prediction software is a plus.
• Experience preparing DMPK sections of regulatory submissions.
• Excellent oral and written communication skills.
• Problem solving and critical thinking skills are essential.

#LI-MM1#LI-Hybrid#LI-Remote

Salary Range

$147,000 - $206,333 a year

Compensation & Benefits

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

 

 

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We d