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You are viewing Director / Sr. Medical Director, Clinical Development at Equillium Clinic or Office-based

Full time

Job Description

Primarily responsible for the planning and execution of clinical research activities for relevant programs. Develop the clinical development program and trial protocols in collaboration with all functions, vendors, and consultants.

The leadership of the cross-functional Clinical Development team in collaboration with all functions, as applicable for the agreed upon timelines and budget. Lead medical input for associated programs. A key contributor to monitoring safety and efficacy data in clinical studies and engaging with study investigators.

Provides clinical input in regulatory documents: INDs, BLAs/NDAs, PSURs; Annual Safety Reports, Core Data Sheets, Investigator's Brochures, Clinical Study Reports, Clinical Summaries, and Clinical Overviews (risk/benefit evaluation).

Collaborates with clinical, regulatory, and commercial organizations to develop lifecycle plans, including new indications. Be involved in Business Development activities and due diligence.

Involvement in internal process improvement activities such as SOPs or guidance documents, as assigned.

Potential to manage and mentor other clinical development team professionals and oversee medical monitor and safety review support.

Equillium is looking for medical leadership to lead the clinical development of EQ001 and multi-cytokine inhibitors. This is a great opportunity for an experienced clinical development professional to take on a role in building and leading a fast-moving and nimble development stage company in areas of high unmet need.

The primary objective of this position will be to serve as the lead for a specific clinical development program within Clinical Development and have direct contributions to potentially other programs.

This position will be responsible for directing and leading cross-functional clinical research activities focusing on advancing clinical development programs through all phases of development, including contributing to and participating in regulatory submissions and meetings, taking a lead role in the submission of INDs/BLAs, and contributing to the strategy and execution of lifecycle planning. This role will be accountable for matrix deliverables carried by team projects within the broader clinical development team (internal/external). Examples of matrix team projects include the design, execution, and reporting of clinical trials, analysis of clinical and safety data at the conclusion of each phase of development including BLA/NDA submissions, contributing to medical affairs activities including KOL identification and management, advisory boards, and medical communication activities including publications, pharmacovigilance activities, and translational research and commercial projects. Key measures of success will include the ability to drive, coordinate and harmonize clinical development activities with multiple functional groups with the intent of delivering success by defining clear strategic development plans, communicating timelines and deliverables, ensuring appropriate accountabilities, and demonstrating an ability to lead teams/groups in hitting product development milestones.

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