Director, Clinical Pharmacology
About The Position
The Director, Clinical Pharmacology will serve as the Clinical Pharmacology representative and subject matter expert (SME) on internal development project teams, responsible for the clinical pharmacology profiling of small molecule and biologic drugs in therapeutic areas that include oncology, nephrology, and/or immunology. The Director, Clinical Pharmacology will be accountable for the design and implementation of the clinical pharmacology plans using traditional and model informed drug development (MIDD) approaches that will be used to help facilitate and accelerate drug development. The Director, Clinical Pharmacology will play a pivotal role in the design, planning, execution, and interpretation of clinical pharmacology studies conducted in early, full and life cycle management phases of clinical development. The Director, Clinical Pharmacology will provide input to all applicable clinical development plans, protocols, and clinical study reports. The Director, Clinical Pharmacology will be responsible for the preparation of the clinical pharmacology components of regulatory submissions and will represent Clinical Pharmacology at meetings with health authorities. The Director, Clinical Pharmacology will also help develop and implement processes to improve conduct and management of activities in Clinical Pharmacology group.
Requirements
- PhD preferred, or MS or PharmD with specialty training in Clinical Pharmacology/Pharmacometrics or research fellowship
- Minimum 7 years of pharmaceutical industry experience gained in Clinical Pharmacology
- Knowledge and experience in the application of MIDD, including the development of clinical pharmacology plans that can influence drug development.
- Knowledge of the current practices in the areas of clinical pharmacology, pharmacokinetics, and/or drug metabolism.
- Experience of working on the development of small molecules and/or large molecule biologics.
- Experience in working across the drug development spectrum; experience working on medicines during post-marketing life cycle management is a plus.
- Experience in development and writing of regulatory communications, including summary documents, and query responses
- Experience of working collaboratively with cross-functional partners on project teams, enabling data driven drug development decisions
- Experience mentoring and managing directly or in a matrix environment is a plus
- Experience working at a Japanese based pharmaceutical company a plus
- Proficient in MS Office Suite.
- Proficiency in using pharmacokinetic/pharmacometric software tools including NONMEM, r, Phoenix WinNonLin, NMLE, and/or SAS
- Hands-on analyses and the application of current practices in the areas of clinical pharmacology, pharmacokinetics, and/or pharmacometrics to guide drug development decisions
Responsibilities
- Serve as the clinical pharmacology SME on cross-functional clinical and study teams for development projects
- Responsible for development, planning and execution of clinical pharmacology strategies to support drug development across all phases including life cycle management and global regulatory registrations
- Responsible for designing, coordinating, analyzing, and interpreting clinical pharmacokinetic/pharmacodynamic studies.
- Responsible for the preparation of biopharmaceutics and clinical pharmacology summaries of regulatory submissions.
- Maintain a thorough understanding of regulatory expectations and represent the function at the meetings with regulatory authorities
- Establish processes and capabilities for effective implementation of clinical pharmacology and pharmacometrics strategies for various small molecule/biologics programs at clinical stages
- Collaborate effectively within Global Clinical Pharmacology and cross-functionally within Global Development on project teams to help make data informed development decisions.
- Mentor Clinical Pharmacology Leads and other cross-functional partners in a matrix environment to increase organizational knowledge in MIDD and clinical pharmacology concepts
- Based on skill and experience, manage Clinical Pharmacology Leads, ensuring their professional growth and successful delivery of clinical pharmacology objectives to development teams
- Present and author scientific publications, sharing insights and research outcomes with the broader scientific community.
Benefits
- 401K with company match
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Life & Disability Insurance
- Concierge Services
- Long Term Incentive Program (subject to job level and performance)
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
