Opportunity Details

The client is seeking a Contract Medical Director for an Immuno-Oncology Clinical Development Lead position. The role involves leading the clinical development strategy and execution of a first-in-human study for a novel immunotherapy. Responsibilities include developing clinical study plans, designing Phase 1 trials, collaborating with teams for study execution, overseeing safety as Medical Monitor, and driving cross-functional planning to meet clinical goals. The ideal candidate will have an MD with 5-6 years of experience leading Phase III immuno-oncology trials and deep expertise in biologics-based therapies.

The Contract Medical Director will be responsible for shaping the program's direction and operational success in collaboration with internal and external stakeholders. They will lead SRC meetings, author and review regulatory documents, and represent the program in regulatory, site, and stakeholder discussions. The role requires proven leadership skills in fostering cross-functional team collaboration, as well as the ability to develop actionable clinical strategies from preclinical data. The client values lasting relationships with exceptional biopharmaceutical talent and takes great care to protect personal information of all candidates.

The ideal candidate for this position will have an MD with a preference for U.S. accreditation and a PhD, although the latter is not essential. They should have a strong background in immuno-oncology, particularly in biologics-based therapies, and a track record of successfully leading Phase III trials in this area. The Contract Medical Director will play a key role in driving the clinical development of a novel immunotherapy, ensuring effective study execution and regulatory compliance while working closely with internal and external stakeholders to achieve program goals.