Medical Director, Clinical Development

The Position

The Medical Director role works closely with the Executive Director, Clinical Development, and is responsible for protocol design and scientific oversight of clinical research studies involving new or marketed drugs. S/he will contribute to the clinical development and regulatory strategy for assigned assets, and will also be accountable for the design, execution, oversight, monitoring and report of clinical trials. This position reports into the Executive Director in the Global Clinical Development group within the Clinical Development and Operations organization.

*This position can be remote within the US*

Responsibilities

Protocol design and study execution

• Lead or contribute to the development and updates to the global clinical development plan.
• Work closely with Operations and vendor to identify and/or vet sites for clinical trial participation Design patient-centered clinical protocols that support strategic objectives, are feasibly conducted, and support efficient recruitment to meet program timelines.
• Represent clinical development on study teams, collaborating closely with clinical operations and team members in identifying clinical study issues, barriers to execution, and developing sound strategic solutions with partners of the study team to ensure timely resolution.
• Provide clinical input to clinical study teams for key documents, including informed consent, data review plans, medical monitoring plans, statistical analysis plans, clinical review forms, case report forms, data edit checks
• Participate in design and conduct of Investigator Meetings for clinical trials
• Monitor study conduct to ensure efficient recruitment, high quality of data and fidelity to protocol, and to minimize compliance and quality risks to enable a decisive readout.
• In collaboration with biostats and safety, interpret efficacy and safety data from clinical trials and author CSR.

Medical monitoring

* Directly monitor and p