Director of Medical Affairs
Role Location
Wellesley, MA
Role reports to
CEO
Company Description
Shield is a commercial stage specialty pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol). The Group has launched Accrufer® in the US. Feraccru® is commercialized in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialization of Accrufer® / Feraccru® in China, Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. in the Republic of Korea, VITAL-NET in Japan, and with KYE Pharmaceuticals Inc. in Canada.
Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt based oral therapy for adults with iron deficiency, with or without anemia. Accrufer®/Feraccru® has a novel mechanism of action compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about Accrufer®/Feraccru®, including the product label, can be found at: www.accrufer.com and www.feraccru.com.
Role Description Summary
The Director, Medical Affairs will have the overall responsibility for establishing the strategy, plans, and objectives of the Medical Affairs organization.
The role will have corporate and field-based responsibilities, engage, and further develop deep relationships with the external scientific and medical communities, facilitate education on related disease states, garner insights from the medical and scientific communities and collaborate to support clinical trials as needed.
Core Accountabilities
- Identify and establish a working relationship with key thought leaders.
- Educate KOLs and ensure consistent and accurate medical communications.
- Represent Shield at local/regional/national scientific congresses and professional society meetings.
- Provide medical support for key commercial activities.
- Provide medical support for access strategy, including presentations. Provide medical review of product-related materials, as required.
- Drive development of medical materials for internal and external education
- Support Commercial team with clinical and/or product-related training.
- Develop and deliver scientific/educational programs to related organizations.
- Attend local, regional, and national scientific meetings including staffing medical affairs booths, facilitating scientific communications, gathering competitive intelligence, and developing pre- and post-conference scientific materials.
- Serve as medical expert/representative on the MLR (Medical, Legal, and Regulatory) Committee
- Participate in the development and management of the Accrufer medical affairs budget.
- Support clinical site and investigators as needed.
- Develop Investigator Sponsored Study Strategy, and co-ordinate response to external requests for support for such studies, as required
- Develop and manage timelines on publication plans.
- Oversee drafting, finalization and submission of publications (Abstracts, Posters, Full Manuscripts).
- Contribute to development of Standard and ad hoc Medical Information Responses, in conjunction with Head of PV and MI, as required.
Required Skills & Experiences
- Advanced degree in life sciences or related field required
- Clinical research or experience in one or more of the key therapeutic areas (hematology, women’s health, GI, CKD)
- 8+ years of experience in the pharmaceutical industry, primarily within Medical Affairs
- Ability to understand and effectively communicate scientific data to both internal and external customers, including key external experts and managed care organizations.
- Thorough understanding of applicable federal and state regulatory requirements for field-based scientific personnel relating to dissemination of scientific information required.
- Working knowledge of US health care systems is required.
- Demonstrated ability to develop trust and relationships with KOLs in disease states of interest.
- Collaborative, team-based approach; ability to network and partner with internal and external stakeholders, including commercial and R&D partners, medical experts, academic institutions, large group practices, managed care organizations, medical directors and pharmacy directors in institutional practices.
- Willingness to expand continuously and compliantly medical, scientific, market, and industry knowledge.
- As necessary, ability to work evenings and weekends to attend congress sessions, meeting with industry colleagues, KOLs, etc.
- Ability and willingness to travel up to 40% .
- Excellent written and oral English communication skills using common business technologies (i.e. Microsoft (MS) Word, PowerPoint, MS Teams, SmartSheets, and MS Excel)
- Excellent collaboration, influencing, and communication skills required.
- Must have a valid U.S driver's license and a clean driving record.