Flagship Pioneering, Inc.
Biopharmaceutical
VP/SVP,ClinicalDevelopmentLead–Immunology&ProgramLeadership
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“VP/SVP, Clinical Development Lead – Immunology & Program Leadership at Flagship Pioneering, Inc.. Skills: Immunology, Clinical Development, Program Leadership. Lead clinical development strategy for immunology programs. Design integrated clinical development plans”
What You'll Achieve.
Advance programs from translational stages; Advance programs through IND; Advance programs through early clinical development; Drive successful development of immunology assets; Achieve human proof of concept
Industry & Context.
Risk identification; Cross-functional challenge resolution; Data-driven decision-making
What They're Looking For.
Must Have
MD or MD/PhD required, 15+ years industry experience, Experience leading immunology programs, Experience filing INDs and CTAs, Demonstrated success in enterprise-level Program Leadership, Proven ability to lead cross-functional teams, Experience advancing complex immunology programs
Nice to Have
Board certification in Rheumatology, Immunology, Allergy/Immunology, Dermatology, Gastroenterology, or related specialty preferred
What You'll Do.
Lead clinical development strategy for immunology programs
Design integrated clinical development plans
Provide clinical leadership for Phase I/II studies
Oversee protocol design
Oversee dose selection
Oversee endpoint strategy
Oversee data interpretation
Drive indication prioritization
Drive indication expansion opportunities
Serve as cross-functional Program Team Leader
Align functions around development objectives
Align functions around timelines
Align functions around budgets
Align functions around risks
Align functions around decision points
Lead governance discussions
Lead portfolio reviews
Lead strategic program planning
Partner with Research teams
Partner with Translational Sciences and Medicine teams
Partner with Regulatory Affairs teams
Partner with Clinical Operations teams
Partner with Biometrics teams
Partner with Safety teams
Partner with CMC teams
Partner with Commercial teams
Partner with Business Development teams
Drive integrated program execution
Resolve cross-functional challenges
Enable rapid decision-making
Enable data-driven decision-making
Ensure alignment between clinical strategy and business objectives
Serve as subject matter expert in immunology
Serve as subject matter expert in autoimmune disease
Serve as subject matter expert in inflammation
Interpret clinical data
Interpret translational data
Interpret biomarker data
Interpret competitive data
Integrate biomarker strategies
Integrate patient stratification strategies
Maintain understanding of emerging science
Maintain understanding of treatment paradigms
Maintain understanding of competitive landscape
Serve as internal KOL
Provide strategic guidance
Provide technical expertise
Provide cross-platform insight
Lead program level interactions with global health authorities
Contribute to briefing books
Contribute to regulatory responses
Build relationships with key opinion leaders
Build relationships with investigators
Build relationships with academic collaborators
Build relationships with patient advocacy organizations
Represent company at scientific conferences
Represent company at advisory boards
Represent company at external partnership discussions
Mentor medical directors
Mentor program team members
Foster culture of accountability
Foster culture of innovation
Foster culture of scientific excellence
Contribute to organizational strategy
Contribute to pipeline prioritization
Contribute to capability building
How You'll Work.
Team & Collaboration
Cross-functional teams; Platform companies; Leadership teams; External stakeholders; Global health authorities; Key opinion leaders; Academic collaborators; Patient advocacy organizations
Communication Scope
Executive presentations; Scientific conferences; Advisory boards; Partnership discussions
Process & Methodology
Program Leadership, Strategic planning
Full Job Description
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 b
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