We have a current opportunity for an AD Clinical Pharmacology on a permanent basis. This is a hybrid position (3x a week onsite) and will be based in Chicago, Illinois or South San Francisco, California.
Job Type: Full-Time
Department: Clinical Pharmacology
Reports To: Director of Clinical Pharmacology
Salary: $180,000- $253,500
Job Summary: The Associate Director of Clinical Pharmacology will lead and manage clinical pharmacology activities for drug development programs. This role involves designing and overseeing clinical pharmacology studies, analyzing data, and collaborating with cross-functional teams to support regulatory submissions and clinical development strategies.
Key Responsibilities:
- Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).
- Develop and implement clinical pharmacology strategies to support drug development programs.
- Collaborate with clinical, regulatory, and biostatistics teams to ensure alignment of clinical pharmacology plans with overall development strategies.
- Provide clinical pharmacology expertise in the preparation of regulatory documents, including INDs, NDAs, and BLAs.
- Analyze and interpret pharmacokinetic (PK) and pharmacodynamic (PD) data to inform dose selection and optimization.
- Represent clinical pharmacology in meetings with regulatory agencies and external partners.
- Mentor and develop junior clinical pharmacology staff.
- Stay current with scientific and regulatory developments in clinical pharmacology and related fields.
Qualifications:
- PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Master's Degree or equivalent education and typically 12+ years of experience, Bachelor's Degree or equivalent education and typically 14+ years of experience;(*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
- Proven track record of leading clinical pharmacology studies and contributing to regulatory submissions.
- Strong knowledge of pharmacokinetics, pharmacodynamics, and modeling and simulation techniques.
- Excellent analytical, problem-solving, and communication skills.
- Strategic thinking and enterprise view
- Ability to work effectively in a collaborative, cross-functional team environment.
- Experience with regulatory interactions and submissions is highly desirable.
Preferred Qualifications:
- Familiarity with population PK/PD modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin).
- Strong publication record in clinical pharmacology or related fields.
Benefits:
- Competitive salary and bonus structure.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with company match.
- Professional development opportunities.
- Flexible work arrangements.
