Hobson Prior are currently seeking a (Senior) Medical Director for a brilliant pharmaceutical organisation on a permanent basis in the US. Our client is focused on personalising cancer medicine for the individual needs of patients who live with cancer.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this role, you will be responsible for and involved in the design and implementation of clinical trials of their assigned programs, driving the clinical development plan for new compounds and/or indications.
• You will be responsible for managing the operational planning, content, execution and delivery for the company's programs and studies. Providing critical input to the design of clinical trials and managing the development of clinical trial protocols, amendments, informed consents and overseeing data review activities and communicating with investigator/sites where appropriate.
• The Director Clinical Development will work closely with Program Clinical Development Lead, and represent the company in collaboration projects with industry partners as appropriate. They will also contribute to interactions with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. They will support the VP Clinical in the development of presentations to senior management and decision makers.
• Responsible for generating and reviewing high quality clinical regulatory documents Investigational New Drug (IND) Applications, Briefing Documents, Investigational Brochures, Investigational Product Labeling, IND annual reports, Investigational Medicinal Product Dossiers (IMPD), common technical documents as the basis for new drug applications (NDA) and Marketing Authorization Applications, other EMA/CHMP regulatory documents and scientific white papers.
• Assumes Global Clinical Development Study Lead responsibilities; working together with the Program Clinical Lead to develop and implement CDP and design clinical trials.

Requirements:

• The ideal candidate will require a M.D. and/or M.D. Ph.D with strong scientific and clinical background in Infectious diseases OR Oncology.
• Proficiency in English (written and spoken).
• Strong experience within biotech/pharmaceutical setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA/BLA submission.
• A genuine interest and understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
• Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
• High level of comfort and demonstrated successes working in a matrix environment (global and cross-functional), including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners.
• Provides subject matter expertise and has a genuine interest to mentor and develop others.
• A thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on trial design and respective dossier preparation and submission activities.
• Experienced in global health authority interactions (EMA, FDA, CDE). Having participated or led a drug development program to successful registration is an advantage.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.