Vice President, Medical Affairs

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary:

The Vice President of Medical Affairs will provide global strategic direction and tactical execution of medical affairs activities at Alkeus with an initial focus in the gildeuretinol program. Reporting to the Chief Medical Officer, the VP of Medical Affairs will lead a cross-functional medical organization spanning Patient Advocacy, Medical and Scientific Communications, Medical Directors, Medical Operations, Medical Information, and Field Medical (MSLs). Collaborating closely with Clinical Development, Regulatory, Commercial, and other functions within and outside the company, this role will ensure scientific excellence across stakeholder engagement, evidence generation, medical communications, and phase 3 trial support activities. This individual will represent the medical perspective across senior leadership forums within the company and to outside stakeholders as appropriate. This leader will create a modern, compliant, and evidence-based Medical Affairs team that meaningfully serves patients.

Primary Responsibilities:

• Lead the development and execution of the Global Medical Affairs strategy.
• Be a senior scientific advisor to the CMO and executive team, contributing to portfolio strategy, life cycle planning and other activities as determined.
• Lead, build and develop a high performing medial affairs team.
• Oversee field medical strategy and operations for MSL teams.
• Provide leadership and strategic oversight for scientific content development, external stakeholder engagement, congress strategy, publications, and advisory boards.
• Lead the development of an integrated evidence plan, including publication strategy and ensure timely delivery of high impact presentations, manuscripts, and other data dissemination activities.
• Ensure medical input/insights from the field are embedded in key cross-functional activities including research and development, lifecycle management, launch planning, and field enablement.
• Champion the integration of patient and ECP insights into strategic and tactical planning, ensuring a data-driven and customer-centric approach to decision-making.
• Oversee development of medical lexicon, and other content, including, but not limited to disease education, Mechanism of Action, Clinical Data, and Safety information.
  • Ensure highest compliance and quality standards are always implemented.
  • Build a Medical Review Process for external materials and ensure alignment with evolving data, external feedback, and labeling.
• Partner cross-functionally with the Global Development Team to support phase 3 trial.
• Build the medical information capabilities including and not limited to the medical inquiry response system, standard response documents, and scientific response teams.
• Partner with patient advocacy groups to ensure medical strategy reflects patient reality, current and future projected unmet needs, including diagnostic and treatment journeys.
• Lead HEOR (Health Economics and Outcomes Research) and partner with market access to shape evidence relevant to payers and health care systems globally.
• Represent Alkeus externally with high scientific and behavioral integrity at major scientific meetings, professional meetings at local and regional levels globally.
• Strong collaboration with the Clinical Operations Team
• Lead with a performance-driven, people first mindset, promoting accountability, innovation, excellence and growth across the medical team and the broader organization.
• Mentor and develop talent through intentional coaching, career path planning, and succession development.
• Manage and oversee the medical budget, ensuring efficient resource utilization and investment in areas of highest impact.
• Deliver on other related projects as assigned.

Qualifications:

• Education and Certification
• MD, OD, PhD, PharmD, or other terminal degree in a clinical or scientific discipline; Ophthalmology related is highly preferred.
• Work Experience
• 10+ years of Medical Affairs experience in roles with increasing responsibility and accountability for medical affairs planning and tactical execution.
• 5+ years of experience leading Medical Affairs teams across multiple products or within complex therapeutic areas.
• Ophthalmology and/or rare disease experience preferred.
• Skills and Key Success Factors:

• Experience with leading a Medical Affairs organization during phase 3 trial execution and commercial launch.
• Deep understanding and experience in evidence generation, publication planning, congress strategy medical engagement, regulatory environment, field medical operations, and scientific communication/ education
• Deep upholding and understanding of global compliance frameworks.
• Strong Understanding of clinical research and pharmaceutical development
• Comfort working in a fast-paced environment with high visibility and impact.
• History of building and leading high-performing teams with a focus on talent development and inclusive leadership.
• Highly organized and detail oriented with a passion to deliver quality results.
• Excellent verbal and written communication skills, with experience translating complex concepts for various audiences, ability to influence “without authority.”
• Scientific credibility and executive presence with global retina Key Opinion Leaders
• Patient centric approach
• Proven and successful track record as a team-player and collaborator in working environments
• Highest levels of professionalism, compliance, scientific integrity, and ethical standards

Other Relevant Information:

• Travel: Able to travel up to ~40-60% of time, including global travel

Compensation

• Base Salary Range: $310,000 - $390,000, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 30% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

Alkeus Pharmaceuticals, Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We participate in E-Verify and conduct background checks as a part of our employment process.