Vice President/Head of Medical Affairs
Our client is a biotechnology company developing precision medicines for patients with kidney diseases. They apply their proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. The development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities. The company recently in-licensed a late-stage product and plans to initiate a phase 3 trial for chronic kidney disease during 2020. Their pipeline has several other internal programs at the validation and lead optimization stages, the first of which is rapidly progressing to enter clinical trials by 2021. They are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.
The company has raised a $65 million Series A financing from top tier venture capital firms. The company has approximately 30 employees and is based in Vancouver, British Columbia and Seattle, Washington. They have asked us to assist them in their search for a Vice President/Head of Medical Affairs
The Vice President/Head of Medical Affairs will set the company’s scientific strategy to prepare for the launch of a commercial product in approximately a 3 to 4-year time horizon. This individual will interact with KOLs in the broader renal community, specifically glomerular disease experts, to inform the scientific community on the company’s mission, stimulate recruitment to patient trials, and interact with clinical trial leads to shape the organization’s medical communication strategy. The Vice President/Head of Medical Affairs will be responsible for ensuring the company successfully initiates a Phase 3 trial in primary glomerular disease in the second half of 2020, followed by a Phase 2 glomerular disease basket trial in 2021, as well as an ultra-rare kidney disease Phase 1 trial in the first half of 2021. As the organization grows, the Vice President/Head of Medical Affairs will have the potential to build out a team of MSLs to effectively disseminate scientific information globally. This position is based in Seattle and Vancouver, and will consider candidates who are willing to travel extensively to Seattle.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- 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 are required.
The Company is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.