Position OverviewThe Vice President, Clinical Development (Gastroenterology) is a strategic physician leader responsible for shaping and executing the clinical development strategy for Uniquity Bio's clinical programs. Reporting to the Chief Medical Officer, this role will provide medical and scientific leadership across all phases of development, from clinical proof-of-concept through registrational studies and lifecycle planning.
The successful candidate will serve as the clinical lead for assigned aspects of Uniquity programs, partnering closely with Clinical Operations, Translational Medicine, Regulatory Affairs, Biometrics, Clinical Pharmacology, Medical Affairs and external experts to drive the design, execution, interpretation and communication of clinical studies. This individual will play a key role in interactions with regulatory agencies, key opinion leaders, investigators, partners and investors while helping build Uniquity Bio's gastroenterology development capabilities.
Key ResponsibilitiesClinical Development Leadership- Lead the clinical development strategy and execution for Uniquity programs.
- Serve as the medical lead for clinical trials and integrated development plans across Phase 1 through Phase 3 development.
- Develop and maintain comprehensive Target Product Profiles (TPPs), clinical development plans and lifecycle management strategies.
- Provide strategic input into indication selection, clinical positioning, competitive differentiation and portfolio prioritization.
- Ensure clinical programs are aligned with regulatory expectations, commercial opportunities, unmet patient needs and scientific advancements.
Clinical Trial Design and Execution- Author and oversee clinical sections of protocols, investigator brochures, clinical study reports, regulatory submissions and other study-related documents.
- Provide medical oversight of ongoing clinical trials, including safety monitoring, data review, protocol interpretation, eligibility adjudication and benefit-risk assessment.
- Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums.
- Collaborate with Clinical Operations to ensure studies are conducted on time, within budget and to the highest quality standards.
Scientific and External Engagement- Build and maintain relationships with leading gastroenterologists, allergists, immunologists, physician investigators, patient advocacy groups and scientific experts.
- Represent Uniquity Bio at scientific congresses, advisory boards, investigator meetings and regulatory interactions.
- Monitor emerging scientific literature, competitive intelligence and evolving treatment landscapes to inform development strategies.
- Contribute to publications, abstracts, presentations and other scientific communications.
Regulatory and Cross-Functional Collaboration- Serve as a key contributor during regulatory agency interactions, including FDA, EMA and other global health authorities.
- Partner closely with Regulatory Affairs in preparing briefing books, meeting materials and submission documents.
- Work collaboratively across Research, Translational Medicine, Biomarkers, Clinical Pharmacology, Biostatistics and Medical Affairs functions to ensure integrated development planning.
- Help establish clinical development processes, governance structures and best practices appropriate for a growing biotechnology company.
Leadership Responsibilities- Mentor and develop clinical scientists and physician colleagues as the organization grows.
- Contribute to organizational strategy and decision-making as a member of the Clinical Development leadership team.
- Support business development activities, including due diligence reviews, asset evaluations and partnership discussions, as needed.
- Foster a culture of scientific rigor, accountability, collaboration and patient-centricity.
- Ability to clearly communicate and present scientific and complex information to senior leaders and board of directors.
QualificationsRequired- M.D. or equivalent medical degree from an accredited institution.
- Specialty in Gastroenterology; board certification preferred.
- At least 5 years of relevant clinical and/or biopharmaceutical industry experience, including substantial experience in clinical drug development.
- Demonstrated experience serving as a clinical lead for gastroenterology-related development programs.
- Strong understanding of clinical trial design, biostatistics, drug development, regulatory requirements, and benefit-risk assessment.
- Experience leading multidisciplinary teams in a matrixed environment.
- Proven track record of contributing to clinical development strategies and regulatory interactions.
- Excellent written, verbal and presentation communication skills.
- Ability to thrive in a hands-on, dynamic, fast-paced biotechnology environment.
Preferred- Prior experience developing therapies for eosinophilic gastrointestinal disorders, inflammatory bowel disease, immune-mediated diseases or related gastroenterology indications.
- Experience supporting late-stage clinical development and/or regulatory approval activities.
- Knowledge of biologics development and immunology-driven therapeutic approaches.
- Previous clinical leadership experience in biotechnology or pharmaceutical organizations.
- Track record of publications in high-impact peer-reviewed journals and presentations at major scientific conferences.
- Experience interacting with FDA, EMA and other global health authorities.
- Excellent team player with a "win together" mindset.
Work EnvironmentAt 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.
