Develops, implements, and manages comprehensive Clinical Pharmacology plans and strategies that align with commercial objectives and regulatory standards across multiple functions. Initiates and leads new PK/PD study proposals. Proactively assesses and addresses advancements, strengths, weaknesses, opportunities, and threats in Clinical Pharmacology, PK/PD, and regulatory landscapes, adapting strategies accordingly. Demonstrates a strong track record of achieving Clinical Pharmacology and business goals. Oversees Clinical Pharmacology/PK/PD aspects of various projects, ensuring thorough evaluation of technical and scientific elements in collaboration with Clinical Pharmacology and Pharmacometrics management.
Description:
- Responsible for designing Phase 1-4 studies and developing clinical pharmacology strategies; serves as the project representative.
- Executes strategies, leads teams, and interprets data by providing necessary context, including explaining mechanisms of action, disease specifics, relevant data, analysis plans, and model results.
- Authors regulatory documents such as protocols, study reports, population PK reports, exposure-response analyses, CTDs, label sections, investigator brochures, white papers, and similar documents.
- Leads clinical pharmacology and biopharmaceutics meetings, represents Clinical Pharmacology at Clinical Strategy Team/Asset Development Team, and presents at various departmental and cross-functional teams.
- Guides small teams within Clinical Pharmacology to present a unified position to clinical, CMC, and regulatory teams.
- Authors scientific publications, presents at national and international conferences, and interacts with key opinion leaders and external stakeholders.
- Conducts due diligence assessments, summarizes findings, and represents Clinical Pharmacology on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Qualifications:
- Required to be on-site 3 days a week.
- PhD with 4+ years of experience, PharmD with 6+ years of experience, Master's Degree with 12+ years of experience, or Bachelor's Degree with 14+ years of experience in relevant fields (e.g., PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, drug metabolism/transporters).
- Excellent interpersonal skills.
- Ability to interact with functional representatives and key opinion leaders, and lead teams.
- Strategic thinking and broad perspective.
- Proven scientific track record and technical expertise.
- Key Leadership Competencies:
- Delivers business results while positioning the company for long-term success.
- Persistent and resilient, advancing good ideas.
- Acts with respect and courage.
- Connects unrelated concepts and generates unique ideas.
- Influences colleagues for cross-functional alignment.
- Delegates and accepts accountability.
Additional Information:
- Compensation range is based on job grade and may vary by geographic location. The range may be adjusted in the future.
- Comprehensive benefits package includes paid time off, medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term and long-term incentive programs.