VP/SVP, Clinical Development Lead - Immunology & Program Leadership

VP/SVP, Clinical Development Lead – Immunology & Program Leadership

Cambridge, MA USA

Position Summary

What if... We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines' approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

We are seeking a highly accomplished VP/SVP, Clinical Development Program Leader with deep expertise in Immunology and demonstrated Program Leadership experience to drive the strategy, execution, and cross-functional advancement of multiple innovative therapeutic programs entering the clinic. This role reports to the Chief Medical Officer of Pioneering Medicines. This individual will partner closely with platform companies, Flagship leadership, and external stakeholders to advance programs from early translational stages through IND and early clinical development.

This role is distinct in its portfolio-wide impact and platform-integrated model, requiring a leader who can operate across multiple programs, and modalities. This individual will serve as both the clinical leader and a key program enterprise leader , responsible for integrating scientific, clinical, operational, regulatory, and portfolio considerations to drive successful development of immunology assets from early clinical development through human proof of concept and beyond.

The ideal candidate is a seasoned physician-scientist with deep translational medicine expertise and an enterprise leader with a strong track record of advancing complex immunology programs, leading cross-functional teams, influencing organizational strategy, and operating effectively in a dynamic biotechnology environment.

Key Responsibilities

Clinical Development Leadership

• Lead the overall clinical development strategy for multiple immunology programs across early development.
• Design and oversee integrated clinical development plans aligned with scientific rationale, patient needs, competitive positioning, and corporate objectives.
• Provide clinical leadership for Phase I and II studies, including protocol design, dose selection, endpoint strategy, and data interpretation.
• Ensure clinical programs are executed with scientific rigor, operational excellence, and regulatory compliance.
• Drive indication prioritization and expansion opportunities.

Program Leadership & Cross-Functional Integration

• Serve as the cross-functional Program Team Leader or senior program representative, aligning functions around key development objectives, timelines, budgets, risks, and decision points.
• Lead governance discussions, portfolio reviews, and strategic program planning activities with leadership at Pioneering Medicines, Flagship Pioneering and Platform companies.
• Partner closely with Research, Translational Sciences and Medicine, Regulatory Affairs, Clinical Operations, Biometrics, Safety, CMC, Commercial, and Business Development teams.
• Drive integrated program execution by proactively identifying risks, resolving cross-functional challenges, and enabling rapid, data-driven decision-making.
• Ensure alignment between clinical strategy and broader portfolio/business objectives.

Scientific & Medical Expertise

• Serve as a subject matter expert in immunology, autoimmune disease, inflammation, and related therapeutic areas.
• Interpret clinical, translational, biomarker, and competitive data to inform program direction.
• Collaborate with translational and precision medicine teams to integrate biomarker and patient stratification strategies into development plans.
• Maintain deep understanding of emerging science, treatment paradigms, and competitive landscape in immunology.
• Serve as an internal KOL for Immunology Development across the FSP ecosystem
• Act as a recognized scientific and translational thought leader in immunology development, providing strategic guidance, technical expertise, and cross-platform insight to portfolio companies and internal stakeholders across the Flagship ecosystem.

Regulatory & External Leadership

• Together with Regulatory, lead program level clinical and strategic interactions with global health authorities, including FDA, EMA, and other regulatory agencies.
• Contribute to INDs, CTAs, briefing books, and regulatory responses.
• Build and maintain relationships with key opinion leaders, investigators, academic collaborators, and patient advocacy organizations.
• Represent the company at scientific conferences, advisory boards, and external partnership discussions.

Organizational & Team Leadership

• Mentor and develop medical directors and program team members.
• Foster a culture of accountability, collaboration, innovation, and scientific excellence.
• Contribute to organizational strategy, pipeline prioritization, and capability building within Clinical Development.

Qualifications

Required:

• MD or MD/PhD required.
• Board certification in Rheumatology, Immunology, Allergy/Immunology, Dermatology, Gastroenterology, or related specialty preferred.
• 15+ years of biotechnology and/or pharmaceutical industry experience in clinical development.
• Significant experience leading immunology and inflammation clinical programs across multiple phases of development.
• Demonstrated success in enterprise-level Program Leadership within a matrixed organization.
• Proven ability to lead cross-functional teams and influence strategic decision-making at the executive level.
• Strong understanding of global regulatory requirements and drug development processes and experience filing INDs and CTAs.
• Demonstrated ability to engage effectively with C-level executives and senior stakeholders, including presenting strategic recommendations, managing executive communications, and supporting high-level decision-making.
• Exceptional communication, leadership, organizational, and stakeholder management skills.
• Background in translational medicine and biomarker-driven clinical development.
• Experience with biologics

Preferred

• Experience with cytokine modulation, or precision immunology approaches.
• Prior experience in leading multicenter proof of concept trials in inflammatory bowel disease, inflammatory arthritis and other immunology indications
• Prior experience supporting NDAs or BLAs and product approvals.
• Track record of mentoring high-performing teams.
• Experience conducting trials in APAC

Core Competencies

• Strategic Clinical Development Leadership
• Enterprise Program Leadership
• Deep Immunology Expertise
• Cross-Functional Team Leadership
• Portfolio & Risk Management
• Regulatory Strategy
• Data-Driven Decision Making
• Executive Presence & Communication
• Operational Excellence
• Collaboration & Influence

About Flagship

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health, sustainability, and beyond. What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our team of scientists, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people and planet. Many of the companies Flagship has founded have addressed humanity's most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.

Flagship has been recognized twice on FORTUNE's "Change the World" list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company's annual list of the World's Most Innovative Companies.

At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the