Associate Scientific Director, Derm US Medical Affairs
Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: generation of clinical and scientific data/publications, in-field/MSL strategy and initiatives, health-care provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); Medical Educational initiatives, Medical Review, conducting phase 3b/4 studies and safeguarding patient safety. Works closely with cross-functional teams (sales, marketing and HEOR, Market Access, Commercial) teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Works closely with cross-functional teams (sales, marketing, commercial, HEOR, Market Access) to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. 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.
- Independently contributes to the development of asset/brand strategies.
- Leads development & execution of Medical Affairs Plans.
- Ability to design, evaluate & execute various types of research (clinical research, Phase IIIb-IV, epi, EDA, RWE research). Understands the healthcare and bio-pharmaceutical business environment. Able to develop and execute an issue management program to anticipate, plan for and respond to issues.
- Able to lead and influence cross functional teams.
- Able to manage brand medical affairs budget including timelines, compliance requirements.
- 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. Responsible for Tier 1 EE development within the Therapeutic Area.
- Leadership in Medical Information including; anticipating brand MI needs (e.g. generation of AMCP/GC Value Dossiers, Medical Information communication content).
- May contribute to regulatory strategy, labeling and agency interactions. Experience with generating regulatory documents. 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.
- Leadership in Medical Review by providing scientific guidance and issue resolution. May manage and oversee the work of Medical and/or Scientific Directors at Director, Associate and Assistant levels.
- Advanced Education PhD, PharmD, MD or equivalent highly preferred. Residency or additional post doctorate highly preferred.
- Typically 10 years' 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 and issues. Proven leadership skills in a cross-functional environment. International experience is 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 process excellent oral and written communication skills.
- Works mostly independently with limited guidance.
- Can address complex problems within discipline and project or across disciplines (i.e. GSS).
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Works on problems of diverse scope in which analysis and interpretation of data requires multiple factors.
- Relocation to home office required.