The Medical Affairs Director Dermatology will report to the aVP, Medical Affairs Dermatology, as a key medical/scientific resource in the development and implementation of the medical affairs strategy for Dermatology. He/she will coordinate and lead medical activities linked to tildrakizumab, Absorica, Levulan and Odomzo. Among these responsibilities, the Medical Affairs Director will actively manage, lead, and deliver medical advisory boards, the investigator sponsored studies (ISS) program, medical affairs strategies and medical education programs. He/she will review medical/ scientific content of promotional materials (as needed), develop external expert relationships and serve as a scientific/medical consultant for Marketing, Health Outcomes, Access, Marketing & Sales, and participate in the development of medical strategies to appropriately position dermatology products as part of the Sun portfolio. The Medical Affairs Director will select and manage external vendors, as well as plan and manage the annual medical affairs budget to assure effective delivery of the medical affairs plans.
This position reports directly to the aVP, Medical Affairs, Dermatology and will manage multiple internal relationships within Sun Pharma. He/she will collaborate with clinical development, pharmacovigilance, medical information, commercial, finance, communication, and field-based teams.
Responsible for the creation of educational curricula to train sales representatives, Drug Information specialists, and field-based MSLs. In conjunction with the aVP, Medical Affairs, leads the Sun Pharma medical department in regulatory interactions, ISS, expert advisory board meetings, external professional societies, seminars, and conventions.
Stays abreast of regulatory requirements and guidelines, current trends, and medical practice in the field of dermatology and immunology, including intelligence on new technologies or treatment advances; is an expert in the pharmaceutical industry code of professional conduct.
B. Medical Communications
Responsible for developing a specific medical education strategy (CME, medical grants, professional societies), incorporates them into the medical affairs plans, and assesses their impact. Participates in the development of publications strategy (primary, secondary, post hoc and HEOR), working closely with the publication lead. Responsible for promotional materials as a key member of the Medical-Regulatory-Legal review team, as needed. Supports Medical Information and Field MSLs training and governance. Reviews press releases and all external public relations materials for accuracy of medical and scientific content.
C. Regulatory/Safety Activities
Responsible for the ongoing safety and product labeling from a medical perspective. Participates in the interpretation of regulatory guidelines and directives to judge risk and causality. Effectively communicates safety data to medical and commercial teams. Works closely with Clinical Development in selection of phase IIIb/IV investigators/sites, and guiding interpretation of results. Participates in the medical definition and implementation of labeling strategy.
D. Sales/Marketing Support
Presents clinical data at regional and national advisory boards. Responsible for providing medical input to market strategy, marketing plans and promotional campaigns. Responsible for medical input to commercial advisory boards, speaker training, and other marketing activities as needed. Participates in the development of medical product support and development plans in concert with Sales and Marketing. Assists Marketing in developing external relationships with academic and community medical departments, professional associations, and P&T committees.
STRATEGY AND PROTOCOL DEVELOPMENT
Participates in developing specific phase 3b/4 trial strategy in conjunction with the clinical development team, including study prioritization. Incorporates medical affairs plans, as well as ISS strategy. Collaborates closely with the HEOR group on related activities, providing input into early economic models/endpoints, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications. Builds relationships and maintains a strong external expert network.
, KNOWLEDGE, and SKILLS
MD, PhD, PharmD, with prior direct patient care or clinical trial management experience.
Five years or more of pharmaceutical industry experience, in the field of immunology and/or dermatology preferred.
Strong strategic mindset, understanding of physician, patient and payer needs in a changing healthcare delivery environment.
Strong project management skills and budget management experience.
Based in Princeton, NJ but able to travel up to 25% of the time.