Description

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:
The Director, Clinical Pharmacology and Pharmacometrics reports to the Head of CPP within Global Clinical Development. This translational role within the Clinical Development organization supports both Research and Development. The Director Clinical Pharmacology position will support the clinical pharmacology programs for an expanding portfolio of therapeutics across several disease areas. This role will independently execute routine clinical pharmacology tasks with minimum supervision and will include oversight of vendors and/or contractors.
The role requires a leader who leverages strong scientific expertise, sound decision making, and strong collaboration skills to drive alignment across teams on nonclinical and clinical development strategies. They oversee or conduct the analyses necessary to interpret collected data and provide strategic expertise to advance development decisions within a dynamic, matrixed environment

What You'll Do:

• Represent Clinical Pharmacology and provide PKPD support to projects assigned by the Group Lead

• Independently lead and oversee the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data of assigned projects.

• Review and Design Clinical Pharmacology development strategies to facilitate new drug development and drug approval

• Provide Model-based development input, including PPK analysis, for overall clinical development strategy

• Design and conduct PK/PD analyses to guide development decisions of project teams.

• Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.

• Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.

• Preparation of abstracts and manuscripts for publication.

• Closely partner with Research, Clinical functions, Regulatory, Project Management, and other R&D functions. Participate in preclinical study design and documentation as they relate to Translational activities needed in advance of planned clinical development programs.

• Participate in clinical study design and documentation (lab manual, protocol, SAP)• Provide input into applicable sections of clinical documents, consolidating feedback from SME, including study protocols, regulatory documents and communications (IND, NDA, BLA, PMA, etc.), Briefing Book (BB), Investigatory Brochure(IB), Clinical Study Reports (CSR), study start up (e.g. ICF, data transfer agreements) and data base lock activities (e.g. sample reconciliation, data review/QC and transfer), etc.

Who You Are:

• PhD in Pharmacokinetics, Pharmacology, Pharmaceutics or M.D. or PharmD with equivalent experience or Master's degree in Pharmacokinetics, Pharmacology, Pharmaceutics

• Minimum of 10 years (for PhD, MD or PharmD) or 12+ years (for Master's) of experience in the pharmaceutical industry

• Demonstrated knowledge in pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology

• Demonstrated experience with drug development programs and with clinical pharmacology related regulatory guidelines

• Expert knowledge of pharmacokinetic, modeling and data visualizations software

• Strong (English) communication skills (verbal and written) and presentation skills are required

• Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential

• Demonstrated problem solving and critical thinking skills

Where You'll Work:

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel:

This role requires occasional [domestic/international/global] travel (approximately [5%-15%])

Pay Range:
$185,000.00-252,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 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
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or
• An alternative selection process by emailing Privacy@insmed.com.
• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.