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Director, Scientific & Medical Affairs

Company: LFB USA, Inc.
Location: Framingham
Posted on: September 12, 2020

Job Description:

Director, Medical and Scientific Affairs Job Locations US-MA-Framingham

Job ID 2020-1404

# of Openings 1

Category Clinical/Medical

Company LFB USA

Overview The Director of Medical and Scientific Affairs (DMSA) reports to the Sr. Medical Director. The DMSA will work closely with Commercial, Regulatory, Clinical, and Corporate Affairs to execute upon strategic Medical Affairs plans for the approved products/brands within LFB’s portfolio.

The DMSA works closely with internal cross-functional teams, and our external strategic partners on the development, alignment, and the execution of Medical and Scientific Affairs strategy for assigned product(s), launch plans, and commercial programs throughout life cycle management.

Responsibilities The DMSA will interface with cross-functional teams providing medical insight and scientific expertise; participating in key strategic decisions that impact the life cycle planning of LFB’s products.

The DMSA will manage Medical Affairs activities relevant to the science, disease state and competitive clinical data pertinent to an assigned product/program.

The DMSA will be asked to oversee internal and liaise with external partner Medical and Scientific affairs personnel including Medical Science Liaisons (MSLs) as necessary and appropriate.

The DMSA will be the Commercial Medical Representative on the MLR committee. The DMSA may also participate or be involved in the Joint Publication Committee (JPC), and the Strategic Alignment Committee (SAC) as necessary and appropriate. He/she will keep up to date on literature in the necessary therapeutic areas/fields and understand the competitive product landscape(s).

The DMSA will participate in the development of integrated US launch plans and serves as the US DMSA representative on the extended launch teams for assigned commercial products.

The DMSA develops medical strategies and activities, including conference plans, and implement these in collaboration with strategic partner, regional and the relevant country medical leads.

The DMSA will solicit and include strategic partners, regional/country feedback where possible in global deliverables.

The DMSA will provide scientific and medical expertise to develop positioning, key messages, and Q&A documents supporting discussions with payers and policy makers as required.

The DMSA will be involved in medical review and provide input for key product regulatory labeling activities for pre-commercial or already commercial products and the associated indications.

The DMSA will work with regional medical teams to establish and maintain strong relationships with key opinion leaders (KOLs) and public health bodies and be involved in the review of Investigator Initiated Research (IIRs) proposals or protocol, Phase IV studies, and requests for products for research purposes.

Under leadership of the Sr. Medical Director, and working with other multidisciplinary team members, the DMSA will participate in alignment activities between Strategic Partners and/or 3 rd party clients.

The DMSA will participate in developing and implementing Medical Affairs processes and projects within the Portfolio function as part of continuous business improvement and lead and/or contribute to functional projects as required.

The DMSA will represent the Brand as medical subject matter expert (MSME) when necessary and appropriate.

Qualifications A medical doctor (MD) degree, complemented with post-graduate qualification and experience in the pharmaceutical/ biotechnology industry field, with a background in blood diseases, hemophilia and hemostasis at a minimum.

5 + years’ medical affairs or related industry expertise with extensive knowledge and experience of product launches and Medical Affairs in relevant therapy area and experience in biologics, blood diseases hemophilia and hemostasis is preferred.

Experience working in an International/Global Pharma company is also preferred.

Excellent communication skills, both oral and written, and able to engender trust and respect of colleagues.

Display the scientific acumen and communicative abilities to effectively engage with thought leaders, medical affairs leadership, research and development, management, and other key internal and external stakeholders.

Demonstrated understanding of relevant connections and integration points between Medical Affairs and stakeholders across the R&D, Clinical, Regulatory, and Commercial functions.

Proven track record of fostering teamwork, leading cross-functional teams, timely decision making and results orientation in meeting objectives.

Demonstrated ability to articulate and negotiate projects and priorities across functions and/or organizations.

Leadership and management skills, and ability to work as team player and/or lead teams directly.

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Keywords: LFB USA, Inc., Framingham , Director, Scientific & Medical Affairs, Other , Framingham, Massachusetts

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