Assistant Scientific Director, Medical Affairs - Cross-Franchise & BioTherapeutics
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).
Key Responsibilities Include:
- Assist in the development & execution of Medical Affairs Plans.
- May assist with the scientific review, development, execution and communication of medical affairs sponsored or supported clinical research activities (clinical research, Phase IIIb-IV, epi, EDA, RWE research).
- Able to actively participate in and influence cross functional teams.
- Serves as key internal subject matter expert for the TA. Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
- With support of TA Lead/Head, is able to influence Scientific Publication strategy, co-authors Scientific publications, ensures medical/scientific accuracy of Scientific publication content. Able to advance Scientific Communication Platform.
- May contribute to regulatory strategy, labeling and agency interactions. Stays abreast of key regulatory policies (especially pertinent to human research, scientific exchange and Medical Affairs) as well as regulatory guidance in the therapeutic area. Contributes to drug safety/PV and risk management plans. Support & contribute to safety/PV tactics.
- Provide leadership in Medical Review of marketing material by providing accurate and timely scientific review.
- Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical/marketing activities (promotional material generation/product launches). Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
- Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred
- Ability to provide input and direction to clinical research with appropriate supervision
- Strong desire to collaborate in a cross-functional setting
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable
- Ability to interact externally and internally to support global scientific and business strategy
- Must possess excellent oral and written English communication skills