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Director, Medical Affairs - GI

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Research & Development
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185788 Requisition #
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Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

 

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

 

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

 

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

 

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

 

We are currently expanding our International Medical Affairs team based out of our offices in Marlow and are recruiting for a Director in Medical Affairs who has made GI their area of expertise. This role is a key strategic leadership role within Global Medical Affairs and the Chief Medical Office (CMO). Working under the leadership of the Global Therapeutic Area Head, GMA SP, this role develops a comprehensive medical strategy for each of the products within their respective area of responsibility. The Director will work closely with CMO colleagues in Global Patient Safety & Epidemiology (GPSE), Global Evidence & Value (GEV) and Global Medical Excellence (GME), as well as colleagues within the broader R&D and Commercial organizations. 

 

Key deliverables include the development of the Medical Affairs strategy and tactics for the respective therapeutic area that includes data generation, scientific communications and synthesis of insights.  This leader will provide medical practice insights to support the clinical development, HEOR, publications, marketing, sales, and regulatory functions to ensure that they are developing product and development strategies that will be relevant to the market - patients, payors and physicians. Additional activities, special projects and assignments may be given, as required.  As a result, the percentage of time spent across key duties and responsibilities will vary depending on project assignments, therapeutic area needs and the requirements within GMA SP.

 
KEY DUTIES AND RESPONSIBILITIES:
  • Leadership of the GMA SP Therapeutic Area Team                                                     
  • Serve as the Medical Affairs TA scientific/disease state expert for CMO, broader R&D, Commercial, Corporate Communications (including Alliance Advocacy, Government Affairs) and other functions within area of responsibility.
  • Manage the development and implementation of the Global TA Medical Affairs strategic and tactical plans.
  • Serve as the CMO Lead for assigned Core teams involving products within the TA
  • Contribute to Commercial planning by leveraging medical/scientific expertise, knowledge of scientific data and understanding of the external healthcare environment.
  • Lead the development and execution of GMA SP data generation plans (e.g. Phase 4 and IIT) plans to provide post marketing data that support our products and the patients and HCPs that use them.
  • Contribute to the development and review of CMO trial proposals and publications.
  • Be responsible for MSL materials and content used in communications
  • Establish and maintain relationships with top tier thought leaders in the respective therapeutic area to establish a strong scientific presence in the clinical and academic communities. Collaborate with the MSL teams to ensure thought leader development and communication is optimized.
  • Assess external IIT proposals and concepts related to the therapeutic area to ensure alignment with strategy

Education and Experience
  • Medical degree, PhD, PharmD and/or other higher scientific degree. Preferably 'board certified specialty qualification' or equivalent and pharmaceutical industry recognized qualification e.g. MSc
  • Significant biopharmaceutical/medical device industry experience, including experience with late phase studies, publications and field-based medical affairs roles.
  • Extensive knowledge of GI is required.
              
Essential Skills and Abilities
  • Must have a solid understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
  • Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
  • Good understanding of Medical Affairs principles, study design and publications.
  • Proficient with electronic systems including: Microsoft Office Suite, SharePoint, videoconferencing platforms
  • Ability to handle and prioritize multiple priorities
  • Self-starter with ability to work independently with remote or minimal supervision
  • Ability to work effectively in a team/matrix environment
  • Ability to influence others without direct reporting relationships

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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