Medical Director, Medical Affairs, Oncology
LOCATION: South San Francisco
DEPARTMENT: Clinical Development
DIVISION: Clinical Development
REPORTS TO: VP, Clinical Development
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages.
The Director of Medical Affairs is responsible for the development of medical strategy, planning & execution of assigned medical affairs activities at Day One. This hire will provide scientific and/or medical leadership by thoroughly understanding oncology and serving as a key scientific/ medical resource.
The Director will work in a multifunctional, matrix organization, working closely with colleagues within the medical affairs group (including field medical, medical operations, medical education, medical information, HEOR, publication management and medical statistics), as well as those in research & development, commercial, access & reimbursement, and patient advocacy. He/she will also collaborate with external collaborators such as health care practitioners, research groups, payers and alliance partners.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Defines strategy, sets annual goals and ensures compliant execution of medical affairs activities.
- Maintains deep scientific and medical knowledge of relevant therapeutic/disease areas as well as an understanding of patient and physician interactions and clinical decision making and impact.
- Provides matrix management of the cross-functional Medical Product Team (MPT)
- Responsible for medical affairs activities consisting of data generation, data analysis and interpretation. Plays a key role in developing evidence generation strategy and execution of Phase 3B/4 studies, including interventional and observational research.
- Provides strategic direction and scientific and medical support for publications and presentations.
- Provides substantial input and reviews development of Medical Information Letters and the Global Value and AMCP Dossiers.
- Participates in scientific engagement with external communities in order to educate and advance scientific and medical understanding of relevant disease areas, including the management of disease, standards of patient care and roles of our medicines.
- Develops medical content for congresses, symposia and advisory boards and leads such activities.
- Presents scientific/ medical materials to diverse audiences (e.g. physicians, pharmacists, marketing/medical agencies, and other key stakeholders) in meeting, advisory and/or consulting settings.
- Proactively brings patients’ & physicians’ voice to provide medicines meeting their needs, on cross-functional teams, while considering the needs of external collaborators, including payers.
- Provides scientific and medical input and ensures integrity of scientific content for promotional activities and sales training. Is the lead medical reviewer in the review committee responsible for the review and approval of promotional, educational and related materials supporting Company products, ensuring medical/ scientific accuracy and fair and balanced representation.
- Supports field medical activities.
- Assesses medical education needs and develops internal and external educational activities.
- Works with finance, multiple functions with Medical Affairs and Project Manager to develop and forecast project budgets for medical affairs activities.
- Provides medical training for internal staff (including RSMs, medical information, commercial, and sales) on products and disease related aspects.
- Potential of direct line management of junior medical affairs colleagues.
- Performs medical monitoring of post-registrational trails and is the signatory of documents related to interpretation of patient level data where necessary, if in possession of a medical degree.
- Physician (M.D. or equivalent), PhD or PharmD with expertise in oncology / immuno-oncology. Experience in pediatric oncology preferred.
- Clinical, research and/or drug-development experience in oncology / immuno-oncology
- Minimum of 10 years’ experience in the pharmaceutical industry and/or medical affairs is required.
- Experience and success in working in a matrix, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results.
- Must be able to demonstrate excellent medical communication skills.
- Must be able to clearly demonstrate a thorough understanding of the healthcare environment including all external stakeholders.
- Must be able to demonstrate understanding of medical affairs accountabilities for evidence generation, external engagement and internal advice; direct experience preferred.
- Must demonstrate disease area expertise and appropriate medical and/or clinical experience
- Ability to travel up to 40% of the time, nationally and internationally
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.