The Scientific Director 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).
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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).
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Qualifications
Basic:
Advanced education (e.g., PhD, PharmD, PA, NP) highly preferred. Residency or/+ post doc highly preferred.
Typically 10 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.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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