Executive Medical Director, Clinical Development- Immunology

Vertex Inc. • Boston, MA

3d • $320,000 - $480,000 • Hybrid

About The Position

Committed to advancing breakthrough treatments for patients with immune-mediated diseases, Vertex is building the clinical organization to match its scientific ambition in immunology. We are seeking a physician-scientist with a comprehensive understanding of molecular pathways as drivers of inflammatory and autoimmune diseases across a range of organs — and of the investigative treatment landscape targeting those pathways — to help shape Vertex's immunology portfolio beyond existing programs. Povetacicept, our lead immunology asset, is a differentiated TACI-Fc fusion protein that dually inhibits BAFF and APRIL, now advancing into a broad portfolio of antibody-mediated autoimmune indications with compelling early signals. As Executive Medical Director, Clinical Development, you will serve as Vertex's primary physician voice on the povetacicept franchise in immunology while contributing your scientific perspective to how Vertex thinks about immunology more broadly about which programs to advance, which mechanisms to pursue, and how to position Vertex as a credible, durable force in a field that is moving fast. This role operates at the intersection of Research, Regulatory, Medical Affairs, Global Patient Safety, Clinical Operations, Commercial, Pharmaceutical Development and Business Development.

Requirements

• Experience interacting with global regulatory agencies including EMA, Health Canda, TGA, PMDA and CDE
• Possess a working knowledge of biostatistics, data management, clinical operations and clinical pharmacology
• Experience in filing and defending US INDs and/or NDAs and/or their international equivalents
• Ability to work in a fast-paced and ambiguous environment, and willing to provide hands-on assistance when needed to junior staff to help teams meet their goals
• Ability to function effectively in a team-based matrix environment
• Ability to work independently to resolve challenges and conflicts
• Excellent computer skills including familiarity using AI-based large language models to solve problems
• Excellent oral and written communication
• Excellent leadership skills
• 15 years pharmaceutical industry experience, including time designing and overseeing clinical trials and/or clinical development program(s), or the equivalent combination of education and experience
• 7 years of people management experience
• Immunology and/or rheumatology expertise
• Board certification/eligibility in immunology or rheumatology

Responsibilities

• Requires comprehensive understanding of the drug development process extending from Phase 1 to Phase 4
• Is a recognized and respected authority in the immunology or rheumatology field
• Has experience overseeing clinical development programs and managing their design and implementation by providing project team leadership
• Participating in the planning and execution of global clinical development activities including setting up data monitoring committees, steering committees, and investigator meetings
• Representing the clinical development team at cross-functional meetings
• Develop study protocols
• Reviewing Investigator Brochures
• Reviewing and evaluating study subject exemptions
• Overseeing medical monitoring of clinical studies
• Assisting medical monitors in evaluating adverse events and safety profiles
• Participating in data reviews
• Participating in the development of briefing books and preparing the team for regulatory interactions
• Interfacing with international regulatory authorities to support development objectives
• Ensuring compliance with Vertex Standard Operating Procedures, International Conference on Harmonization, Good Clinical Practice, and other national and international regulatory requirements
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Benefits

• medical
• dental
• vision
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• educational assistance programs including student loan repayment
• a generous commuting subsidy
• matching charitable donations
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree