Scientific/Senior Scientific Director Medical Affairs- Oncology
Purpose:Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).
- In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.
- Establishes and approves scientific methods for hypotheses, rational, design of affiliate protocols and their reports.
- Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
- Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
- Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.
- May act as medical/scientific leader for projects within an area or across several area.
- May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
- May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
- Initiate research projects and drive them to completion, resulting in high quality publications.
- May lead cross functional sub teams responsible for discrete projects within the therapeutic area (individual publications or study collaborations).
- Advanced education (e.g., PhD, PharmD, PA, NP) highly preferred. Residency or/+ post doc highly preferred.
- Typically 7 yrs experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
- Management and leadership experience at project level, experience with strategic initiatives/issues.
- Proven leadership skills in a cross-functional team environment. International experiences a plus.
- Ability to interact externally and internally to support global business strategy.
- Ability to run a clinical study or medical affairs team independently with little supervision.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Must possess excellent oral and written communication skills.