Vice President, Clinical Development (Gastroenterology)

ADP; Malvern (Chester County); On-site; USD 250,000 - 380,000; Full time

Job summary

Uniquity Bio in Malvern, PA, seeks a Vice President of Clinical Development (Gastroenterology) to shape and drive the clinical development strategy across Phase 1–3 programs. The role reports to the Chief Medical Officer and partners with Clinical Operations, Translational Medicine, Regulatory Affairs and Medical Affairs to communicate complex study results to stakeholders.

The successful candidate will lead multidisciplinary teams, build development plans, and ensure alignment with 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.

Responsibilities

• Lead the clinical development strategy and execution for Uniquity programs across all phases (Phase 1–3).
• Develop and maintain Target Product Profiles (TPPs) and lifecycle management strategies.
• Provide medical oversight of clinical trials, safety monitoring, data review and regulatory submissions.
• Mentor clinical scientists and collaborate across Clinical Operations, Regulatory Affairs, Biostatistics and Medical Affairs.

Skills

Gastroenterology leadership

Clinical development

Regulatory interactions

Leadership in matrix teams

Education

MD or equivalent medical degree

Job description

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Vice President, Clinical Development (Gastroenterology)

Full Time Malvern, PA, US

3 days ago Requisition ID: 1017

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we're looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) indications.

Join us in building an organization where people and science thrive together. You'll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone.

Position Overview

The 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 Responsibilities Clinical 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.
• 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.

Qualifications Required

• 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.

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 on 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.

Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.