Vice President of Clinical Development

BioPhase; San Diego (CA); On-site; USD 250,000 - 360,000; Full time

Job summary

BioPhase seeks a VP, Clinical Development to lead the planning and execution of the lead asset's clinical development program, guiding from research to clinic and coordinating with CMO and executive teams on strategy.

The role directs cross-functional clinical research activities across operations, biometrics, data management, and safety, contributing to regulatory submissions and lifecycle planning for the pipeline.

Qualifications

• MD required.
• Board certification in gastroenterology preferred; related areas also considered.
• Minimum of 8 years in biotech/pharma, incl. 3–5 years in clinical development leadership at Senior Director/VP level.

Responsibilities

• Design and lead early- to late-phase clinical trials for the lead asset.
• Oversee CROs and vendor management for clinical operations.
• Develop and nurture relationships with external KOLs and advisors.
• Monitor program status and provide regular updates to leadership.
• Author/review regulatory documents (INDs, BLAs/NDAs, CSRs).
• Prepare for FDA/EMA meetings and briefing packages; strategize agency responses.

Skills

Interpersonal skills

Presentation skills

Strategic thinking

Cross-functional collaboration

PowerPoint proficiency

Travel up to 25%

Education

MD required

Gastroenterology board certification preferred

Fellowship/training in related area considered

Tools

Excel

Word

PowerPoint

Job description

The primary objective of this position is to lead the planning and execution of the lead asset's clinical development program and to help transition the lead asset from research into the clinic. The VP, Clinical Development will work closely with other functional areas, including Non-clinical and CMC, and will partner with the CMO and executive team on overall clinical strategy.

This role is responsible for directing and leading cross-functional clinical research activities for the lead asset, advancing the program through all phases of development. The VP will contribute to and participate in regulatory submissions and meetings, play a leading role in the preparation of INDs/BLAs, and contribute to lifecycle planning for the lead asset and other pipeline molecules.

The role is accountable for matrix deliverables carried by project teams within the broader clinical development organization (internal and external). Examples include the design, execution, and reporting of clinical trials; analysis of clinical and safety data at the conclusion of each phase of development, including BLA/NDA submissions; support of medical affairs activities such as KOL identification and management, advisory boards, and medical communications including publications; pharmacovigilance activities; and translational research and commercial projects.

Key measures of success include the ability to drive, coordinate, and harmonize clinical development activities across multiple functional groups: defining clear development plans, communicating timelines and deliverables, ensuring appropriate accountabilities, and leading teams to hit product development milestones.

• Develop clinical program strategy and clinical trial designs in partnership with the CMO; present recommendations and help secure endorsement from the Executive Leadership Team and Board of Directors.
• Provide day-to-day leadership of clinical development programs and clinical functions, including clinical operations, biometrics, data management, and drug safety.
• Plan and oversee execution of clinical research activities and operations, including CRO and vendor management.
• Develop and nurture relationships with external KOLs and advisors on key programs; gather input through advisory boards, congresses, and industry meetings.
• Monitor and report program status to leadership, with regular updates on key development projects from inception through implementation.
• Create and/or optimize clinical development processes, including operations, safety, data management, and biometrics.
• Provide clinical input to, and author or review sections of, regulatory documents: INDs, BLAs/NDAs, PSURs, Annual Safety Reports, Core Data Sheets, Investigator's Brochures, Clinical Study Reports, Clinical Summaries, and Clinical Overviews (including risk/benefit evaluation).
• Prepare for and participate in regulatory interactions, including FDA Type B/C meetings and EMA Scientific Advice; contribute to briefing packages and agency response strategy.
• Collaborate with research, safety, regulatory, and commercial teams to develop asset lifecycle plans, including new indications.

Job Requirements

Education

• M.D. required.
• Board certification in gastroenterology preferred; board certification or subspecialty or fellowship training in a related area (hepatology, immunology, rheumatology, or inflammatory/autoimmune disease) will also be considered.

Experience

• MD-trained clinician.
• Minimum of 8 years of experience in the biotechnology or pharmaceutical industry, including at least 3 to 5 years in clinical development leadership roles at the Senior Director or Vice President level.
• Hands-on experience designing and leading early-phase programs, from first-in-human studies (including dose rationale and escalation) through proof-of-concept/Phase 2, including endpoint selection, dose optimization, and regulatory alignment. Experience with late-stage or registrational studies is a plus. Experience leading ulcerative colitis (UC) and/or IBD trials is preferred.
• Domain expertise in gastroenterology and hepatology, immunology, and metabolic/inflammatory conditions relevant to a GI-focused pipeline.
• Track record of contributing to the advancement of novel, first-in-class therapies in complex, cross-functional environments.
• Experience participating in regulatory interactions, including FDA Type B/C meetings, EMA Scientific Advice, and/or CHMP interactions, with experience in briefing package development. Experience leading such interactions is a plus.
• Prior experience leading cross-functional teams on specific drug development projects spanning clinical development and safety, with exposure to global registration and post-approval activities.
• Experience providing strategic and operational leadership, implementing results-driven processes, and working collaboratively with research and commercial teams.
• Ability to think strategically, set project goals, and establish measures of success.
• Understanding of standard industry practices for Good Clinical Practice and ICH guidelines.
• General knowledge of US/EU drug safety and pharmacovigilance reporting requirements.
• Experience in data analysis and medical evaluation of clinical trial data.
• Hands-on experience with regulatory submissions involving clinical trial data.

Skills & Attributes

• Strong interpersonal and influencing skills, with an open and supportive communication style and the ability to work cross-functionally with multiple sites and different personalities.
• Solid business and scientific acumen, strong presentation skills, and the ability to communicate with both scientific and commercially oriented audiences.
• Pragmatic and analytical thinking, with the ability to take a reasoned position based on a diverse set of inputs.
• High energy, a positive outlook, and a "can do" attitude, with a willingness to do what it takes to achieve personal and organizational goals.
• High degree of professionalism, ethics, and honesty, and the ability to serve as a credible and passionate champion for the Company's therapies.
• Strong computer literacy, including Microsoft Excel, Word, and especially PowerPoint.
• Flexibility to adapt in a dynamic, start-up type environment.
• Domestic and/or international travel: up to 25%.