PRIMARY JOB FUNCTION:
Independently executes and effectively communicates Clinical PK/PD development plans and strategies that achieve commercial goals and regulatory requirements. Generates new PK/PD study proposals. Proposes/contributes to PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies.
Consistently demonstrates an excellent record of accomplishment of Clinical Pharmacology and business objectives.
Serves as a lead Pharmacokineticist on multiple studies simultaneously and contributes PK/PD insights into multiple other projects.
Independently conducts due diligence for single compounds and conducts due diligence under the Director's supervision for other projects
Manages personnel (PK Associates) including development, mentoring, and effective delegation.
CORE JOB RESPONSIBILITIES:
Provides expert PK/PD and strategic consultation to GPRD, GPRA, and all levels of management on critical decisions and development plans, for multiple projects within a therapeutic area.
Develops productive collaborations and communications with other groups across multiple disciplines. Effective writer and communicator of PK/PD research or other regulatory materials.
Communicates/presents key PK/PD information/strategy to senior and executive management, regulatory agencies, and external peers. Serves as liaison to other departments /divisions for multiple studies.
Assists in the development of commercial and regulatory strategies by formulating complicated Clinical Pharmacology plans including development activities.
Contributes to the development of Clinical Pharmacology plans to satisfy regulatory expectations and defends plans and interpretation of data to regulatory agencies.
Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information including use of therapeutic area databases.
Independently conducts due diligence for single compounds and conducts due diligence under the Director's supervision for other projects.
Primary contributor to Clinical Pharmacology interpretations of reports for regulatory filings and clinical protocols.
Provides interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions. Primary author in peer-reviewed journals, R&D reports, and/or regulatory documents/filings.
Plans PK/PD projects that include estimates of timelines, and resources, and execute PK/PD projects across all phases of development on time.
Uses an external information network to gain competitive intelligence and act as advocate for integrating this knowledge into the project team’s research efforts.
POSITION ACCOUNTABILITY / SCOPE:
Receives assignments from Director and/or suggests projects to manager, and is responsible for completing PK/PD objectives on schedule and largely unsupervised.
Reviews key decisions impacting PK/PD timelines with department management. Assumes a high level of responsibility in setting and achieving PK/PD goals.
Attends project team meetings and provides recommendations for resolution of problems. Provides input into strategic decisions of the department and project.
Demonstrates a high degree of responsibility in maintaining PK/PD standards, GxP compliance, and operating practices for self and reporting staff.
Independently identifies and communicates issues and opportunities. Guides formation of PK/PD strategy and tactics.
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