Vice President, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic direction and medical expertise for the clinical advancement of our innovative antibody portfolio in IBD.

• Develop and continuously enhance integrated clinical development plans that align with corporate goals, the competitive landscape, and emerging scientific insights.

• Act as a hands-on study lead for the current platform trial, while also contributing to the planning of pivotal studies.

• Personally engage in protocol development, medical reviews, safety assessments, data interpretation, and decision making at the study level for ongoing and future IBD clinical trials.

• Support the medical monitoring team in ensuring prompt responses to investigative sites, providing medical safety oversight, and aiding in the collection of high-quality, clinically robust data.

• Offer medical and scientific leadership for the design, execution, analysis, and interpretation of clinical studies across all development phases.

• Lead protocol development, study execution, data assessment, and interpretation for ongoing clinical trials, collaborating closely with clinical operations, regulatory, biometrics, and other teams to facilitate successful outcomes.

• Drive critical development decisions through the analysis of emerging clinical, translational, safety, and competitive data.

• Chair or participate in governance committees and cross-functional program teams.

• Collaborate closely with Regulatory Affairs, Biostatistics, Clinical Operations, Translational Sciences, Medical Affairs, CMC, Commercial, and Corporate Development teams to ensure synchronized execution of development strategies.

• Foster a culture of scientific excellence, accountability, and collaboration.

• Lead clinical and medical strategies for global regulatory interactions.

• Serve as the primary medical representative for regulatory submissions, including INDs, CTAs, briefing packages, BLAs, NDAs, and related responses.

• Ensure that development programs adhere to global regulatory requirements and industry best practices.

• Provide ongoing medical oversight regarding participant safety and benefit-risk evaluations across assigned programs.

• Review and interpret emerging safety data, and contribute to safety governance activities, including Data Monitoring Committees and internal safety review forums.

• Support signal detection, risk management strategies, and clinical risk mitigation plans.

• Lead and mentor a high-performing clinical development team as the company expands.

• Contribute to corporate strategy, organizational planning, and leadership initiatives.

⛳️ Requirements

• An MD or equivalent medical degree is mandatory.

• A minimum of 7+ years of clinical development experience in the pharmaceutical or biotech sector, with considerable leadership experience in immunology, inflammation, or gastroenterology.

• Training and/or experience in clinical development focusing on gastroenterology or immunology & inflammation is highly preferred.

• Proven success in leading mid- and late-stage clinical development programs.

• Experience in developing antibody therapeutics.

• Experience in overseeing complex, adaptive, umbrella, basket, or platform clinical trials is highly desirable.

• In-depth expertise in inflammatory bowel disease and/or other immune-mediated inflammatory disorders is strongly preferred.

• Significant experience with global regulatory interactions and submissions, including INDs, CTAs, and briefing documents for global regulatory agencies.

• Strong grasp of clinical trial design, biostatistics, translational medicine, drug development, and global regulatory requirements.

• Proven ability to influence strategy and facilitate cross-functional decision-making within a matrixed environment.

• Demonstrated willingness and capability to stay personally involved in study-level execution while simultaneously providing strategic leadership.

• A strategic, entrepreneurial leader capable of balancing long-term vision with hands-on execution in a fast-paced biotech setting.

🏝️ Benefits

• Opportunity to thrive in a fast-paced, dynamic environment where you can help shape the culture of our emerging company, contribute broadly to advancing meaningful medicines, and learn rapidly.

• Competitive market compensation and benefits package, which includes base salary, performance bonuses, equity grant opportunities, and health, welfare & retirement benefits.

• Unlimited PTO.

• Two, one-week company-wide shutdowns each year.

• Commitment to providing professional development opportunities.

• Remote work environment with regular in-person meetings to tackle complex problems and foster relationships.