Director of Client Strategy
Zaelab
Senior Director – Clinical Pharmacology, Pharmacometrics
Biogen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $242,000 - $333,000 per year
Job Level
Senior
About the role
- Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas
- Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions
- Analyzes results, interprets, and recommends action based on study results
- Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards
- Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents
- Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent
- Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company
- Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities
- Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums
- Engages with consultants and advisors in the field, as well as the scientific community at large
- Manages and/or mentors staff within the function and matrix leadership across projects
- Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers
Requirements
- Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field
- 15+ years of direct industry experience in Clinical Pharmacology
- Demonstrated experience in leading teams and/or managing professional staff
- International recognized expert in Quantitative Clinical Pharmacology
- Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies
- Strong knowledge of the drug development process and overall familiarity with the regulatory process
- Direct experience in preparing regulatory submissions and responding to health authority questions
- Extensive record of publications, presentations, invited lectures, and other scientific activities
- Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses
- Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical PharmacologypharmacokineticsQuantitative Clinical PharmacologyClinical Pharmacology strategystudy designdata analysisregulatory submissionsPK/PD analysisadvanced methods for Quantitative Pharmacology
Soft skills
leadershipmentoringcross-functional collaborationcommunicationscientific awareness
Certifications
Ph.D.M.D./Ph.D.Pharm.D.
