Covance Medical Director, Clinical Pharmacology Early Phase in Indianapolis, Indiana

Job Overview

Reporting to the Executive Medical Director, the incumbent will be primarily responsible for providing comprehensive oversight and guidance to medical monitoring aspects of early phase clinical trials. The Medical Director will play a key role in protocol and study design, strategy and execution, troubleshooting, and safety review and escalations. Additionally, he/she will serve as a primary liaison to sponsors/clients, project leadership, internal development teams, and study sites.

The incumbent can be home-based/remote.

  • Reviews and evaluates Clinical Pharmacology study proposals and provides clinical and scientific support, as needed; drafting study outlines/designs and providing guidance on early clinical development strategies

  • Participates in preparing Clinical Development Plans

  • Participates in protocol/synopsis development

  • Acts as Medical Monitor/study support on a protocol/program basis for early clinical trials

  • Manages the identification of medical consultants for specific therapeutic expertise for the conduct and/or peer review requirements of early phase clinical trials

  • Remains current on issues in medical expertise through active, ongoing participation in relevant clinical/scientific meetings and courses

  • Interacts with Covance Early Phase Development Solutions and participates on Molecule Development Teams, as needed

  • Ensures that there is proper medical coverage to cover the medical monitoring safety requirements of ongoing trials during all hours of operation for early phase clinical studies

  • Attends Kick-off Meetings & SIVs/Investigator Meetings, as appropriate

  • Reviews and approves Safety Plans and/or Medical Responsibility Plans

  • Attends team meetings, as needed

  • Reviews study-specific adverse events and safety lab results to identify safety trends; participates in dose escalation meetings, as appropriate

  • Informs sponsor, project manager and clinical sites of relevant safety events, as appropriate

  • Answers Inclusion/Exclusion criteria questions from clinical sites and approves or acknowledges exemptions and violations respectively

  • Reviews serious adverse events (SAE) for content and completeness. Interfaces with the project team and clinical sites to ensure notification of SAEs to the sponsors

  • Reviews Clinical Study Reports (CSR)

  • Delegates the above as appropriate

  • Establishes and maintains close affiliations with the medical community

  • Works in collaboration with the Executive Director and departmental members in developing an CPS strategic growth plan

  • Performs other related duties as assigned

Education/Qualifications

  • MD license or equivalent

  • Specialization in Internal Medicine, General Practice, or Family Medicine highly preferred

Experience

  • Minimum of 8 years of experience in clinical research

  • Strong experience with Phase I clinical trials; Phase IB and IIA is a plus

  • Expertise in early phase study/protocol design and troubleshooting

  • Patient care background

  • Ability to effectively liaise with sponsors, project managers, and study sites

  • Excellent communication and interpersonal skills

Job Number 2018-18224

Job Category Clinical Operations

Position Type Full-Time

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