Vice President, Clinical Development (Gastroenterology)

Mixtalent; United States; On-site; USD 250,000 - 500,000; Full time

Job summary

Mixtalent seeks a Vice President, Clinical Development, Gastroenterology to shape and execute the clinical development strategy across early to registrational studies, reporting to the Chief Medical Officer. This role leads medical oversight of trials and interfaces with regulatory agencies, KOLs, investigators and internal teams to align programs with regulatory expectations and patient needs.

The successful candidate will mentor teams and contribute to lifecycle planning, while representing

Qualifications

• MD or equivalent medical degree required.
• Specialty in Gastroenterology; board certification preferred.
• 5+ years of relevant clinical/biopharmaceutical experience including clinical drug development.
• Demonstrated clinical lead experience for gastroenterology programs.
• Strong understanding of trial design, regulatory requirements, and benefit–risk assessment.

Responsibilities

• Lead the clinical development strategy and execution from Phase 1 through Phase 3.
• Serve as medical lead for trials and integrated development plans; develop TPPs and lifecycle plans.
• Provide medical oversight, safety monitoring, data review, and protocol interpretation for ongoing trials.
• Collaborate with Regulatory Affairs, Clinical Operations, Translational Medicine, Biostatistics, and Medical Affairs.
• Mentor clinical scientists and contribute to organizational strategy and due diligence activities.

Skills

Clinical development leadership

Clinical trial design

Biostatistics

Regulatory understanding

Leadership in matrixed teams

Scientific communication

Education

MD or equivalent

Job description

Vice President, Clinical Development, Gastroenterology

Position Overview

The Vice President, Clinical Development, Gastroenterology is a strategic physician leader responsible for shaping and executing the clinical development strategy for the company'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 company 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 the company's gastroenterology development capabilities.

Key Responsibilities

Clinical Development Leadership

• Lead the clinical development strategy and execution.
• 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 the company 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.