Purpose: Conceives, executes, and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD, or regulatory advances, strengths, weaknesses, opportunities, and threats, and responds with appropriate new strategies. Consistently demonstrates an excellent record of accomplishment in Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.
Responsibilities:
- Accountable for Phase 1-4 studies design and clinical pharmacology strategy; acts as the representative for project(s).
- Executes strategy, leads teams, and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation, and discussion of model results in the context of research question).
- Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant sections of investigator brochures, white papers, and other similar documents.
- Leads clinical pharmacology and biopharmaceutics meetings, serves as Clinical Pharmacology representative at Clinical Strategy Team/Asset Development Team, and presents at various departmental and cross-functional teams such as study teams, Clinical Pharmacology leadership team, and Journal club.
- Drives small teams with members from Clinical Pharmacology functional groups to provide a unified clinical pharmacology position to clinical, CMC, and regulatory teams.
- Authors scientific publications and presents at national and international conferences and interacts with KOLs/external stakeholders.
- Conducts due diligence assessments, summarizes results, and represents Clinical Pharmacology on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Qualifications:
- Ph.D. 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).
- Excellent interpersonal skills.
- Ability to interact with functional representatives and KOLs externally and internally and lead team(s).
- Strategic thinking and enterprise view.
- Proven scientific track record and technical skills to perform the role.
Key Leadership Competencies:
- Delivers business results while also positioning the company for long-term success.
- Persistent and resilient; finds the way to move good ideas forward.
- Acts respectfully yet courageously.
- Connects unrelated concepts, generates original or unique ideas.
- Influences colleagues to achieve cross-functional alignment.
- Gives full accountability when delegating and accepts full accountability when delegated to by others.
- Uses mistakes, failure, and reflection as vehicles for learning and improvement.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A supportive and inclusive work environment.
- The chance to make a meaningful impact on the lives of cancer patients.
