Medical Director​/Senior Medical Leader - Oncology Late Development - Prostate

Director Clinical Research Oncology

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

The Director Clinical Research Oncology is a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program. The Director supports the Clinical Leader and provides active scientific contributions to a cross-functional clinical team developing a compound currently being studied for new oncology applications. He/She provides mentoring and support to the clinical study team and works closely with the clinical project scientists and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology.

Together with the Clinical Leader, the Study Responsible Physician will represent the clinical team in governance and committee meetings relating to the overall strategy and operational implementation of the clinical studies in the development plan.

The role requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards. The successful candidate must be equally comfortable among the team to which he/she is assigned and in the global environment in which the company operates.

The Director Clinical Research Oncology holds overall responsibility for flawless execution of the assigned study/studies, leading the study team in a matrix organization. He/She assists in the preparation of protocol writing for and operational execution of clinical studies. He/She leads the medical review of critical data collected throughout the study. He/She participates in the interpretation and reporting of the results of the research, including submission to health authorities.

He/She evaluates scientific information and new ideas to assist in identifying new research opportunities. The Director supports medical affairs activities involving product evaluation, labeling and surveillance. He/She will assess external clinical research proposals involving company products and manuscripts that are being prepared for publication. The Director acts as a liaison between the company and clinical investigators. The Director develops, in concert with senior clinical staff, credible relationships with opinion leaders, and clinical research staff globally.

The Director Clinical Research, Oncology reports directly to a Clinical Leader for the product to which he/she is assigned.

Essential Functions

• Leads the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program.
• Works closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders.
• Provides support for clinical study/studies within a development program including:
• Working closely with clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths.
• Working in partnership with clinical project scientists to ensure development of high quality study protocols including use…