Vice President Senior Vice President, Clinical Development Lead – Immunology & Program Leadership

Position Summary

What if... We could harness the power of Flagships scientific platforms and create novel treatment options thatbenefitmore 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 Flagships scientific platforms and applying those innovative approaches to serious diseases with unmet medical Pioneering Medicines approachis the opportunity to combine platforms to create truly novel and potentially transformative treatments.

We areseekinga highly accomplishedVP/SVP Clinical DevelopmentProgramLeaderwith deepexpertiseinImmunologyanddemonstratedProgram Leadershipexperience todrivethe strategy execution and cross-functional advancement ofmultipleinnovative therapeutic programsentering the role reportsto the Chief Medical Officerof Pioneering MedicinesThis 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 canoperateacross multiple programs and individual will serve as both theclinical leaderand a keyprogram enterprise leader responsible for integrating scientific clinical operational regulatory and portfolio considerations to drive successful development of immunology assets from early clinical development throughhumanproof of concept and beyond.

The ideal candidate is a seasoned physician-scientistwith deep translational medicineexpertiseandanenterprise leader with a strongtrack recordof advancing complex immunology programs leading cross-functional teams influencing organizational strategy andoperatingeffectively in a dynamic biotechnology environment.

Key Responsibilities

Clinical Development Leadership

• Lead the overall clinical development strategy formultipleimmunology programs acrossearlydevelopment.

• Design and oversee integrated clinical development plans aligned with scientific rationale patient needs competitive positioning and corporateobjectives.

• Provide clinical leadership for Phase Iand IIstudies including protocol design dose selection endpoint strategy and data interpretation.

• Ensure clinical programs are executed with scientific rigor operational excellence and regulatory compliance.

• Driveindicationprioritizationandexpansion opportunities.

Program Leadership & Cross-Functional Integration

• Serve as the cross-functional Program Team Leader or senior program representative aligning functions around key developmentobjectives timelines budgets risks and decision points.

• Lead governance discussions portfolio reviews and strategic program planning activitieswith leadership at Pioneering Medicines Flagship Pioneering and Platform companies.

• Partner closely with ResearchTranslationalSciencesand Medicine Regulatory Affairs Clinical Operations Biometrics Safety CMC Commercial and Business Development teams.

• Drive integrated program execution by proactivelyidentifyingrisks resolving cross-functional challenges and enabling rapid data-driven decision-making.

• Ensure alignment between clinical strategy and broader portfolio/businessobjectives.

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.

• Maintaindeepunderstanding of emerging sciencetreatmentparadigms and competitive landscape in immunology.

• Serve as an internal KOL for Immunology Development across the FSP ecosystem

• Actas a recognized scientific and translational thought leader in immunology developmentprovidingstrategic guidance technicalexpertise and cross-platform insight to portfolio companies and internal stakeholders across the Flagship ecosystem.

Regulatory & External Leadership

• Together with Regulatory leadprogram levelclinical and strategic interactions with global health authorities including FDA EMA and other regulatory agencies.

• Contribute to INDs CTAsbriefing books and regulatory responses.

• Build andmaintainrelationships 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 andprogramteam 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/PhDrequired.

• 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 experienceleading immunology and inflammation clinical programs across multiple phases of development.

• Demonstrated success in enterprise-level Program Leadership within a matrixedorganization.

• 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 processesand 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 modulationor precision immunology approaches.

• Prior experience in leading multicenterproof of concepttrials in inflammatory bowel disease inflammatoryarthritisand other immunology indications

• Prior experience supportingNDAs or BLAsand product approvals.

• Track recordof 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 islargely withoutprecedent. Our team of scientists entrepreneurial leaders and professional capital managersare eachaligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people andplanet. Many of the companies Flagship has founded have addressed humanitys 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 FORTUNEs 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 Companys annual list of the Worlds 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 manyformsskills 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 Pioneerings internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $252000 - $400000. Compensation for the role will depend on a number of factors including a candidates qualifications skills competencies and experience. Pioneering Medicines currently offers healthcare coverage annual incentive program retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Mediciness good faith estimate as of the date of publication and may be modified in the future.

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