Head of Medical Affairs

Company: Fairway Consulting Group
Location: Vancouver
Posted on: September 13, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

Develops medical affairs strategy and plans with cross-functional teams working closely with key stakeholders including the Heads of Regulatory Affairs, Clinical Operations, CMC, and R&D stakeholders.

Works with future CMO to shape direction of overall medical organization.

Ensures Medical Affairs provides medical/scientific leadership to the organization, creating a culture ensuring medical accuracy of the company’s scientific strategy.

Ensures all Medical Affairs staff act as company ambassadors, establishing company awareness and scientific reputation.

Ensures all activities are compliant with global, regional and local regulations, with appropriate processes and documentation.

Provides medical/scientific expertise to cross-functional teams throughout development and commercialization. As a content expert, reviews abstracts, publications, medical information letters, and other medical documents as needed.

Works with R&D to maximize clinical trial execution, facilitating communications between Company and study investigators.

Develops the Scientific Communications strategy to support global, regional and local objectives, developing and executing product Publication Plan and Medical Education Plans, including dissemination of clinical trial results both at scientific meetings and in peer reviewed journals.

Ensures excellent external stakeholder engagement, working with cross-functional colleagues, including mapping and profiling of KOL’s, understanding stakeholder needs and value drivers and mapping patient journey.

Plans and leads advisory boards and trainings including development of content and presentation of data.

Develops and leads infrastructure to identify, assess and execute specific data generation projects to address identified medical data gaps, including Investigator Initiated Studies.

Ensures rapid and accurate responses to external and internal medical information enquiries from clinical trial sites.

Ensures operational excellence, including developing and measuring clear Medical Affairs KPIs, objectives and development plans.

Ensures all relevant insights, knowledge and activity is systematically captured and disseminated within the company as appropriate.

Manages resources/budget allocation necessary to deliver on strategic and operational plans.

Provides a resource of deep scientific expertise in renal biology and disease, and maintain high visibility among internal and external peers.

Contributes to the development and maintenance of a positive team-focused company culture.

MD/PhD/PharmD Ph.D. with 10+ years of experience in the medical affairs arena is required.

Prior scientific knowledge and experience in the renal disease arena strongly preferred, specifically glomerular disease. Alternatively, clearly demonstrated the ability to master a new therapeutic area deeply and quickly.

Must have 10+ years of medical affairs leadership experience in the pharmaceutical, biotechnology industry, preferably including headquarters and field experience.

Requires experience in the evolving healthcare system, with payers, IDNs or both.

Successfully supported the launch of multiple transformative drugs, preferably in renal disease space is required.

Must have strong and consistent track record of success, developing strategy and executing operational plans.

Must possess a strong understanding of medical management principals and experience with supporting data analytics focused on outcomes analysis and management.

Prior experience in a decision maker role in a startup life science company is preferred.

Requires intimate understanding of the role of healthcare regulators and compliance.

Must have experience in handling media / PR issues.

An ability to form a strong network of influential relationships with KOLs is required.

Requires a pragmatic business approach to problem solving.

Must be a confident and engaging presenter as part of the business team and to conference audiences.

Requires understanding the science and business of medicine, and can speak both languages.

High level of emotional intelligence along with outstanding ability to lead and inspire others is required.

Must translate concepts and ideas into timely action and high-impact results; known for both innovation and execution.

Requires strong executive presence, able to communicate complex ideas with clarity and concision.

High energy, collaborative spirit and an entrepreneurial mindset is required.

Must be comfortable with ambiguity and uncertainty.

Positive attitude and high personal and ethical standards in achieving corporate goals re required.

Keywords: Fairway Consulting Group, Vancouver , Head of Medical Affairs, Other , Vancouver, Washington