Director, Clinical Pharmacology
Insmed Incorporated
5 hours ago
Remote
United States
Clinical Research and Development
Director, Clinical Pharmacology and Pharmacometrics
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 (PK) & pharmacodynamic (PD) data for 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.
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA, and NDA.
- Prepare appropriate documents/sections of clinical protocols, Investigator Brochures, and Clinical Study Reports for Clinical Pharmacology studies/data.
- Prepare abstracts and manuscripts for publication.
- Partner with Research, Clinical, Regulatory, Project Management, and other R&D functions; participate in preclinical study design/documentation for translational activities.
- Participate in clinical study design and documentation (lab manual, protocol, SAP).
- Provide input into clinical document sections, consolidating SME feedback for materials including protocols, regulatory communications (IND/NDA/BLA/PMA), Briefing Book, Investigational Brochure, Clinical Study Reports, study start-up (e.g., ICF, data transfer agreements), and database lock activities (e.g., sample reconciliation, data review/QC and transfer).
Who You Are (Qualifications)
- PhD in Pharmacokinetics, Pharmacology, or Pharmaceutics, or M.D./PharmD (or equivalent experience); or Master’s degree in Pharmacokinetics, Pharmacology, or Pharmaceutics.
- Minimum 10 years (PhD/MD/PharmD) or 12+ years (Master’s) of pharmaceutical industry experience.
- Demonstrated knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
- Demonstrated experience with drug development programs and clinical pharmacology regulatory guidelines.
- Expert knowledge of pharmacokinetic, modeling, and data visualization software.
- Strong English communication (verbal/written) and presentation skills.
- Excellent interpersonal skills; ability to function in a highly matrixed environment.
- Demonstrated problem-solving and critical thinking.
Where You’ll Work / Travel
- Fully remote role.
- Occasional travel expected (approximately 5%–15%).
Application Instructions
- Current Insmed employees: Apply via the Jobs Hub in Workday.
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 (PK) & pharmacodynamic (PD) data for 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.
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA, and NDA.
- Prepare appropriate documents/sections of clinical protocols, Investigator Brochures, and Clinical Study Reports for Clinical Pharmacology studies/data.
- Prepare abstracts and manuscripts for publication.
- Partner with Research, Clinical, Regulatory, Project Management, and other R&D functions; participate in preclinical study design/documentation for translational activities.
- Participate in clinical study design and documentation (lab manual, protocol, SAP).
- Provide input into clinical document sections, consolidating SME feedback for materials including protocols, regulatory communications (IND/NDA/BLA/PMA), Briefing Book, Investigational Brochure, Clinical Study Reports, study start-up (e.g., ICF, data transfer agreements), and database lock activities (e.g., sample reconciliation, data review/QC and transfer).
Who You Are (Qualifications)
- PhD in Pharmacokinetics, Pharmacology, or Pharmaceutics, or M.D./PharmD (or equivalent experience); or Master’s degree in Pharmacokinetics, Pharmacology, or Pharmaceutics.
- Minimum 10 years (PhD/MD/PharmD) or 12+ years (Master’s) of pharmaceutical industry experience.
- Demonstrated knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
- Demonstrated experience with drug development programs and clinical pharmacology regulatory guidelines.
- Expert knowledge of pharmacokinetic, modeling, and data visualization software.
- Strong English communication (verbal/written) and presentation skills.
- Excellent interpersonal skills; ability to function in a highly matrixed environment.
- Demonstrated problem-solving and critical thinking.
Where You’ll Work / Travel
- Fully remote role.
- Occasional travel expected (approximately 5%–15%).
Application Instructions
- Current Insmed employees: Apply via the Jobs Hub in Workday.