Director, Deal Desk
IDC
Associate Scientific Director – Clinical Pharmacology
Biogen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $163,000 - $225,000 per year
Job Level
Lead
About the role
- Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development)
- Provide functional representation on development program and study teams
- Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical)
- Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies
- Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results
- Serve as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documents
- Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed
- Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes
- Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent
Requirements
- PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields
- 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
- Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles
- Experience designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies
- Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm
- Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data
- Experience with use of PK/PD software packages such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS
- Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards.
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 pharmacologypharmacokineticspharmaceuticsPK/PD analysisclinical study designregulatory guidelinesquantitative pharmacology methodologydata interpretationclinical pharmacology strategyrisk mitigation
Soft skills
leadershipcommunicationcollaborationstrategic thinkingproblem-solvinganalytical skillsinterpersonal skillsalignment with cross-functional teamstime managementadaptability
Certifications
PhD in PharmacologyMD/PhDPharmD
