VP, Gastroenterology Clinical Development

Uniquity Bio, Inc.; Malvern (Chester County); On-site; USD 320,000 - 520,000; Full time

Job summary

Uniquity Bio is seeking a Vice President, Clinical Development (Gastroenterology) to shape and execute the clinical strategy across programs, reporting to the Chief Medical Officer. This physician leader will drive design, execution, interpretation and communication of studies from proof-of-concept to registrational stages.

The role collaborates across Clinical Operations, Translational Medicine, Regulatory Affairs, Biostatistics and Medical Affairs, with responsibility for regulatory

Qualifications

• MD 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.

Responsibilities

• 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 Target Product Profiles (TPPs), clinical development plans and lifecycle management strategies.
• Ensure clinical programs are aligned with regulatory expectations, commercial opportunities, unmet patient needs and scientific advancements.
• 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.
• Build and maintain relationships with 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.
• Serve as a key contributor during regulatory agency interactions, including FDA, EMA and other global health authorities.
• Partner with Regulatory Affairs in preparing briefing books, meeting materials and submission documents.
• Work across Research, Translational Medicine, Biomarkers, Clinical Pharmacology, Biostatistics and Medical Affairs to ensure integrated development planning.
• Help establish clinical development processes, governance structures and best practices for a growing biotechnology company.
• 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.
• Foster a culture of scientific rigor, accountability, collaboration and patient-centricity.
• Ability to clearly communicate and present scientific information to senior leaders and board of directors.

Skills

Clinical leadership

Drug development

Regulatory knowledge

Communication skills

Team leadership

Cross-functional leadership

Education

MD or equivalent

Gastroenterology specialty

Board certification preferred

Job description

Uniquity Bio is seeking a Vice President, Clinical Development (Gastroenterology) to shape and execute the clinical strategy across programs, reporting to the Chief Medical Officer. This physician leader will drive design, execution, interpretation and communication of studies from proof-of-concept to registrational stages.

The role collaborates across Clinical Operations, Translational Medicine, Regulatory Affairs, Biostatistics and Medical Affairs, with responsibility for regulatory