What are the responsibilities and job description for the Associate Director Clinical Pharmacology position at EPM Scientific - Phaidon International?
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.
All candidates should make sure to read the following job description and information carefully before applying.
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 :
Key Leadership Competencies :
What We Offer :
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