Vice President, Medical Affairs

Location
San Francisco, CA
Posted
Sep 11, 2018
Ref
2FoQdn8fwi
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Vice President, Medical Affairs will lead the continued development and execution of Portola’s Medical Affairs strategy.  The position provides medical insight and strategy to all company activities across the organization to ensure that patient outcomes are maximized and medical affairs supports best clinical practices and that company objectives are aligned with Portola’s mission.  The Vice President will represent Portola Pharmaceuticals in scientific presentations, conferences and industry groups; serve as lead spokesperson with KOLs and interact with medical societies, various government agencies, health care systems and health care providers globally.   The Vice President, Medical Affairs will report to the Senior Vice President, Chief Medical Officer.

Responsibilities:

  • Lead the Medical Affairs organization, setting the strategic direction of all Medical Affairs functions across the Portola organization
  • Create and drive medical component of the integrated product strategy and planning in collaboration with Marketing
  • Provide a framework for medical affairs activities globally - outlining medical affairs policy and providing guidance for all activities, providing support (and indirect management of) medical advisors and clearly establishing the medical/commercial role clarity in the US and globally as required
  • Provide forward thinking medical insight into related therapeutic areas for the all Portola products
  • Develop and implement Medical Affairs initiatives to facilitate and further the commercial objectives globally
  • Establish clear directions for the Medical Affairs team, bringing alignment on objectives that support global R&D initiatives.
  • Ensure ongoing capability build and continuous improvement of Medical Affairs team in order to meet technical, medical and interpersonal challenges of their roles.
  • Build and maintain collaborative partnerships with commercial and marketing functions.
  • Drive the IIT strategy and company sponsored post marketing clinical trials - All initiatives to demonstrate coherent strategy, the generation of data according to our evidence gaps and compliance with Quality and compliance guidelines.
  • Maximize brand value proposition in assigned therapeutic areas while partnering with the Commercial in the development and execution of the Medical Marketing plans and commercial activities.
  • Provide scientific support to Marketing, Regulatory, Market Access, Pharmacovigilance and Compliance (risk management) groups.
  • Work with R&D and Risk Management functions to ensure a robust pharmacovigilance strategy in place.
  • Advise on medical safety or clinical issues as required
  • Provide medical support for medical product/commercialization planning, life cycle management and product focused medical activities
  • Provide strategic input into the development of Portola-sponsored phase IIIb/IV trials, both Company initiated and investigator initiated in collaboration with other stakeholders
  • Registries- Assist in the identification and evaluation of potential investigators for clinical studies
  • Assist the clinical trials team in the support and communication with investigators
  • Identify areas of need for external partnerships
  • Participate in the collection and exchange of scientific/technical information important to Portola development efforts
  • Identify key national and regional thrombosis/cardiology/pulmonary key opinion leaders; and function as scientific/clinical contact for Portola
  • Help develop and manage to timelines publication plans of Portola-sponsored studies
  • Evaluate key competitive information to aid the clinical and marketing teams in drug development
  • Provide education to physicians on research and development projects
  • Develop and participate in, advisory boards and medical education programs and represent Portola at major meetings and conferences
  • Maintain clinical and technical expertise in the therapeutic area through review of the scientific literature and attendance at key scientific meetings

Qualifications:

  • Solid background and experience in thrombosis, cardiology, or hematology therapeutic areas and understanding of drug development and life-cycle development of a product
  • MD strongly preferred (or advanced degree, such as PhD or PharmD); 15+ years of pertinent academic, clinical and industry experience
  • Demonstrated executive leadership experience in Medical Affairs in a pharmaceutical/biotech organization, having led a regional/global medical affairs team
  • Global launch experience strongly preferred
  • Awareness of how to optimize development of a drug for commercialization based upon medical unmet needs and value of the asset
  • Understanding of legal principles of compliance with appropriate laws and regulations related to communication of scientific information about pharmaceutical products
  • Demonstrated medical and strategic expertise that translates into strategic thinking
  • Demonstrated track record and ability to create and execute Medical Affairs plans in the areas of Medical Communication, lifecycle management, gap analysis, commercialization support and medical launch
  • Ability to cultivate and maintain relationships with clinical investigators and key opinion leaders in the relevant fields, and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from key opinion leaders
  • Ability to effectively articulate medical and scientific information to a variety of relevant audiences (clinician, scientist, health care organization, etc.)
  • Understanding of the regulatory review process and how to appropriately construct and interpret regulatory claims with specific focus on cardiovascular/thrombosis agents
  • Strong leadership and management skills
  • Ability to manage teams effectively and communicate a clear understanding of project status and direction
  • Experience reviewing, approving and overseeing post marketing clinical studies
  • High attention to detail and proven proactive problem-solving skills