Associate Director / Director, Clinical PharmacologyLocation San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Associate Director/Director of Clinical Pharmacology will report to the Head of Clinical Pharmacology and play a leadership role in the organization. He/she will be a subject matter expert in DMPK and classical and quantitative clinical pharmacology, with a focus on using translational approaches to streamline clinical development and define the optimal dose, route and regimen. This individual will be a Clinical Pharmacology leader on project teams and work with cross-functional stakeholders from Research, Translational, and Clinical Sciences, contributing to biomarker discovery and development, nonclinical development, and clinical development of pipeline molecules. This individual will also be considered for leadership of cross-functional development teams. Additionally, the individual will be accountable for Clinical Pharmacology aspects of regulatory filings, along with presentation of results and key messages to internal teams, executive management, and external collaborators. As a senior member in the Clinical Pharmacology organization, this individual will mentor other Clinical Pharmacology scientists, may have direct management responsibility and will be instrumental in the further advancement of Clinical Pharmacology at BioMarin.
- Clinical Pharmacology lead on multiple project teams across drug modalities (e.g., small molecules, biologics, gene therapies) and therapeutic indications
- Lead cross-functional matrix team personnel within BioMarin and contribute to strategic and scientific planning and execution
- Accountable for developing and implementing translational strategy with a focus on clinical dose, route and regimen selection
- Analyze and interpret PK/PD data from nonclinical and clinical studies using appropriate quantitative methodologies
- Supervise and/or mentor Clinical Pharmacology scientists and contribute to process improvement with an eye towards efficiency and consistency
- Interact with external collaborators, key opinion leaders, and vendors
- As the Clinical Pharmacology lead, author sections of regulatory documents and represent the function at regulatory interactions
- Lead cross functional process initiatives to improve consistency in deliverables and interactions with internal partners
- Represent Clinical Pharmacology on due diligence teams
- 8+ years of industry experience in Clinical Pharmacology working in a matrix environment on drug development teams.
- Extensive knowledge of DMPK, clinical pharmacology and pharmacometric concepts, regulatory requirements, strong quantitative skills and knowledge of pharmacokinetic/metric analysis software
- Clinical Pharmacology leadership experience representing the function in both strategic and scientific team settings
- Excellent written and verbal communication skills and experience in regulatory interactions
- 10+ years of experience in Clinical Pharmacology across the drug development paradigm
- Experience with PBPK modeling, pediatric extrapolation and pediatric drug development
- Clinical Pharmacology experience with gene therapies, biologics, and small molecules.
- Cross-functional team leadership and supervisory experience.
M.D, Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or a related field or Pharm.D with a Clinical Pharmacology fellowship.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.