Position Overview

The Vice President, Medical Affairs is a highly visible, hands-on leader responsible for building and executing Uniquity Bio's Medical Affairs strategy and capabilities as the company advances its pipeline through mid- and late-stage development. Reporting to the Chief Medical Officer, this individual will translate emerging clinical and scientific evidence into a clear medical strategy, establish trusted relationships with the external medical community and prepare the organization for future approvals and commercialization.

This is a player-coach role for a leader who pairs strong scientific credibility with a willingness to personally produce critical work. The successful candidate will set direction while also developing medical plans, engaging key external experts, leading advisory boards, shaping evidence-generation and publication strategies and creating the operating foundation for a scalable Medical Affairs function. The VP Medical Affairs will be a member of the clinical development leadership team.

Key Responsibilities

Medical Strategy and Function Building

• Develop and execute integrated Medical Affairs plans for solrikitug and future pipeline programs, aligned with clinical development, regulatory and corporate priorities.
• Build fit-for-purpose Medical Affairs capabilities, processes, governance and vendor partnerships appropriate for a growing clinical-stage biotechnology company.
• Personally create and deliver high-priority medical plans, scientific materials, insights and external-engagement activities while the function scales.
• Establish clear objectives, budgets, operating metrics and decision frameworks that demonstrate the impact of Medical Affairs.

External Scientific Engagement

• Build and maintain trusted, peer-to-peer relationships with key opinion leaders, investigators, academic centers, and professional societies..
• Lead advisory boards, scientific exchange, and congress activity planning and execution enabling Uniquity presence and visibility.,.
• Drive and execute patient advocacy group engagement plan and strategy
• Develop an external expert engagement strategy and translate field insights into actionable recommendations for development and evidence planning.
• Represent Uniquity Bio with scientific credibility, sound judgment and a patient-centered perspective.
• Take an active part in national PI programs to support enable clinical operational success for Uniquity programs.

Evidence Generation and Scientific Communications

• Identify evidence gaps and lead the development of an integrated evidence-generation plan, including company-sponsored research, investigator-sponsored studies, real-world evidence and health outcomes research, as appropriate.
• Develop and execute a robust integrated evidence generation plan spanning across Ph3, Ph3B, HEOR and translational research.
• Own publication strategy and execution across manuscripts, abstracts, posters, oral presentations and congress activities in partnership with relevant functions.
• Develop clear scientific narratives and medical communication platforms that accurately convey disease state, clinical and HEOR evidence and the potential value of Uniquity Bio's programs.
• Ensure medical and scientific materials are accurate, balanced, current and compliant according to pharma regulations.

Cross-Functional Partnership and Readiness

• Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Commercial, Market Access, Patient Advocacy and other functions to integrate medical insight into company strategy and execution.
• Provide medical perspective on clinical development plans, endpoint strategy, data interpretation, lifecycle planning and unmet patient needs.
• Lead advocacy building activities, build and lead MSL function, drive medical education activities and strategies in line with go to market strategy across the prelaunch period.
• Lead Medical Affairs readiness for late-stage development, regulatory milestones and potential commercialization, with disciplined prioritization appropriate for a lean organization.
• Develop disease-state and product education for internal teams and external audiences, consistent with applicable laws, regulations and industry standards.

Leadership and Execution

• Serve as a contributing member of the leadership team and provide clear, evidence-based medical counsel to executive and program leaders.
• Recruit, lead and develop a high-performing Medical Affairs organization over time, using a thoughtful mix of internal talent and external expertise.
• Set a culture of scientific rigor, accountability, urgency, collaboration, and ethical decision-making.
• Remain close to the work: independently engage external experts, review data, draft key materials and drive deliverables through completion.

Qualifications

Required

• Advanced scientific or clinical degree (M.D., D.O., Pharm.D., Ph.D. or equivalent); medical degree strongly preferred.
• At least 10 years of progressive experience in Medical Affairs, Clinical Development or a closely related function within biotechnology or biopharmaceutical organizations.
• Strongly prefer candidates with GI background.
• Demonstrated success developing and executing Medical Affairs strategy for clinical-stage or launch-stage specialty products.
• Experience building capabilities, programs, or teams in a small, emerging or rapidly evolving biotechnology environment.
• Strong record of external scientific engagement with key opinion leaders, investigators, professional societies and patient communities. A strong understanding of, and experience in gastrointestinal disease area with knowledge of key scientific clinical stakeholders and overall landscape.
• Experience leading evidence generation, scientific communications, publications and congress strategy.
• Ability and willingness to operate as a player-coach and personally produce high-quality deliverables.
• Strong working knowledge of relevant legal, regulatory and compliance requirements governing Medical Affairs.
• Excellent scientific judgment, executive communication and cross-functional leadership skills.

Preferred

• Experience in immunology, inflammation, respiratory medicine, gastroenterology, or another relevant specialty therapeutic area.
• Experience with biologics and evidence strategies supporting complex or immune-mediated diseases.
• Meaningful pre-launch and launch experience, including building Medical Affairs capabilities ahead of a first or early commercial product.
• A record of scientific accomplishment demonstrated through publications, presentations, academic collaboration or recognized therapeutic-area expertise.
• Experience developing field medical, medical information, patient advocacy or medical operations capabilities.
• Prior success working across U.S. and global development or commercialization activities.

Work Environment

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.

This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee's manager. Business travel may be required depending upon the specific needs of the position.

The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.