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

Pioneering Medicines is dedicated to conceiving and developing a broad portfolio of life-changing treatments by leveraging and expanding the use of Flagship’s multiple bioplatforms and Flagship’s proprietary innovation process. By harnessing the power of Flagship’s first-in-category platforms, Pioneering Medicines creates and advances novel medicines, partnering with Flagship companies to accelerate the extension of their portfolios into new areas and show that the platform can be applied more broadly, thereby delivering benefits to more patients, sooner. With a highly experienced drug development team and access to the wide ecosystem of Flagship companies, Pioneering Medicines is well positioned to conceive new medicine ideas both internally and in collaboration with strategic partners and advance these assets through to significant value inflection. 

Position Summary

As the Director, Business Development, Transactions you will be responsible for leading strategic transactions for Pioneering Medicines and for select company's across the Flagship ecosystem.  This role requires the ability to influence up, down and across the ecosystem as well as strong organizational, communication and presentation skills. The successful candidate will have scientific acumen, the ability to think and act strategically, be deeply collaborative, and will thrive in a fast-paced, entrepreneurial environment.

Key Responsibilities

In this role you will lead the structuring, negotiating and completion of in-licensing, out-licensing and asset sale transactions for Pioneering Medicines and for negotiating all types of strategic transactions for companies across the Flagship ecosystem.  Additional responsibilities include leading diligence and financial analysis in support of new deals and presenting key findings to company leadership and investment decision-makers. 

Specific Responsibilities

• Collaborate closely with other members of the Partnering team and cross-functional leaders to shape and execute Flagship's business development strategy.
• Establish credibility across the organization through a deep understanding of the biotech and pharmaceutical deals landscape.
• Prepare opportunity assessments with scientific/portfolio rationale, partnership framework and financial assessment, analysis of competitive landscape and comparable deal terms
• Foster strong cross-functional collaboration with R&D, operations, finance, and legal.
• Drive engagement with potential top tier pharmaceutical partners establishing relationships and communicating the vision of the Flagship ecosystem.
• Identify, implement, and continuously refine best practices for partnership operations, program tracking, and execution.
• Lead the coordination and execution of key internal Partnering meetings, ensuring effective agenda setting, action tracking, and follow-up.
• Develop guiding principles and objectives, then track execution against these objectives; develop joint ways of working, and participate in health checks for key partners.

Key Qualifications

• Bachelor’s degree in life sciences, business administration, or a related field; MBA or relevant advanced degree a plus.
• Expertise with contracts and a track record of negotiations.
• 5+ years of experience in business development, partnership management or alliance management within a large pharma or biotech environment.
• Strong analytical, financial, problem-solving, and decision-making skills with the ability to manage multiple priorities.
• Ability to interface with external partners.
• Demonstrated experience managing complex relationships and driving operational efficiencies.
• Proven ability to collaborate across diverse functions and lead cross-functional initiatives.
• Excellent communication and organizational skills with strong executive presence.
• Strong leadership skills and proven ability to influence others to reach common goals as well as act independently.
• Ability to thrive in a fast-paced, evolving environment and drive continuous improvement.
• Self-motivated, attention to detail, and proven ability to work well in teams.

What We’ll Offer You

• Comprehensive, competitive healthcare and dental coverage through Blue Cross Blue Shield, vision coverage through VSP, family leave, paid flexible time off, 401k retirement plan, disability and life insurance, mental health program via Calm, backup care for children/senior and fully covered parking/commuter benefits.
• A dynamic work environment with entrepreneurial spirit and highly interdisciplinary, talented, and collaborative team. Opportunities to work with Flagship scientific platforms/portfolios and create novel treatment options that benefit more patients sooner.
• Professional growth opportunities through mentoring, training, immersion in cross-functional projects, and opportunities to learn and try new things.

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 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.

#LI-TD1

The salary range for this role is $172,000 - $236,500. Compensation for the role will depend on a number of factors, including a candidate’s 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 Medicines's good faith estimate as of the date of publication and may be modified in the future.

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

Pioneering Medicines (PM), 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.

Position Summary:

We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously. This is a senior leadership role operating at the intersection of science, strategy, and operations—requiring the ability to set direction across a complex multimodality pipeline, and build CMC function as a competitive advantage for Pioneering Medicines. This position reports to the SVP, CMC & Technical Operations.

This role will serve as the strategic and operational owner of CMC across the full PM portfolio from research interface through early and late clinical development. This leader will be equally comfortable shaping long-range CMC strategy at the portfolio level and resolving complex technical challenges at the program level. They will define how PM approaches emerging modalities, build and leverage a best-in-class external Contract Development and Manufacturing Organizations (CDMO) network, combined with the strategic acumen to make portfolio-level resourcing decisions. They will be a thought leader in innovative approaches and champion adoption of AI-enabled CMC tools.

Responsibilities:

• Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
• Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team; invest in talent and cultivate a culture of excellence, accountability, and continuous improvement
• Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation
• Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships; Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs
• Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI-driven technical development, manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio
• Engage and align key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to establish CMC development paradigms, resolve cross-functional trade-offs, and ensure portfolio decisions reflect both scientific rigor and operational reality
• Oversee CMC handoffs and establishing fit-for-purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor, as needed
• Serves as an ambassador of PM for external stakeholders and industry as a whole

Requirements:

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered); Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs
• Deep hands-on expertise in small molecules and biologics. Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies
• Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities; Current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
• Proven ability of owning CMC strategy and execution across a multi-program portfolio simultaneously, including developing and managing CMC budgets, risk management, and delivery against aggressive timelines
• Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs with specialized emerging modality capabilities, including leading technology transfer and resolving technical challenges at external sites
• Thought leadership in innovation, including novel delivery, high-throughput process development, and platform-based approaches to elevate program / portfolio value
• Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms to improve development speed and efficiency
• Executive presence and demonstrated ability to influence and align cross-functional PM and platform company leaders; Strong communicator who can translate complex CMC strategy and risk for non-specialist audiences
• Experience partnering with GxP Quality to establish quality systems appropriate for a development-stage organization, including SOPs, change control, and deviation management in a GxP environment
• Entrepreneurial builder energized by creating structure in ambiguous, fast-moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
• Collaborative, low-ego leadership style with genuine investment in team development and cross-functional relationships

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 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 $228,000 - $313,500. Compensation for the role will depend on a number of factors, including a candidate’s 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 Medicines's good faith estimate as of the date of publication and may be modified in the future.

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

ABOUT PIONEERING MEDICINES

Pioneering Medicines, Flagship Pioneering’s in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship’s innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship’s bioplatform companies. Within Flagship’s Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners’ R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.

Position Summary 

The Senior Director, Head of Toxicology will lead and build the toxicology function within Pioneering Medicines, defining and executing nonclinical safety strategies across a diverse and rapidly evolving portfolio. This role provides scientific and strategic leadership across both investigative and regulatory toxicology, supporting a broad range of therapeutic modalities. 

Working in a dynamic venture creation environment, you will collaborate closely with multidisciplinary teams to optimize candidate selection, guide preclinical development, and ensure regulatory readiness. This is a high-impact role requiring strong analytical thinking, scientific rigor, and clear communication, influencing programs from discovery through early clinical development. 

Key Responsibilities 

Functional Leadership & Capability Building 

• Lead, build, and scale the toxicology function, including internal team development and external partnerships  

• Define fit-for-purpose operating models spanning investigative and regulatory toxicology  

• Serve as the primary internal expert for nonclinical safety, ensuring quality, consistency, and scalability across the portfolio  

Portfolio & Program Strategy 

• Define and drive toxicology strategies across multiple programs and modalities   

• Translate findings into clear risk assessments, mitigation strategies, and IND/CTA-enabling plans  

• Enable transparent, data-driven decision-making by articulating risks, assumptions, and trade-offs to program teams  

• Oversee the design, execution, and interpretation of non-GLP and GLP toxicology studies  

• Partner cross-functionally (DMPK, pharmacology, CMC, clinical) to integrate safety into development strategy  

• Support diligence and evaluation of new programs within Flagship’s ecosystem  

External Partnerships & Regulatory 

• Build and manage a high-performing CRO and consultant network, ensuring quality, timelines, and cost efficiency  

• Leverage and contribute to the Flagship ecosystem, fostering knowledge sharing and collaboration across platform companies  

• Lead nonclinical regulatory strategy and documentation (INDs, IBs, briefing materials)  

• Ensure regulatory readiness through clear and scientifically robust safety narratives  

• Represent toxicology in regulatory interactions as appropriate  

Qualifications 

• PhD, DVM, or equivalent in Toxicology, Pathology, Pharmacology, or related field  

• ~10-15+ years of experience in nonclinical safety in biotech/pharma  

• Proven track record advancing programs through IND and into clinical development  

• Experience across multiple modalities preferred  

• Strong experience managing CROs and external collaborations  

• Experience leading or building a toxicology function or team, including management of internal scientists and/or external partners, is a plus  

Leadership Profile 

• Enterprise mindset; able to operate across a portfolio in a fast-paced, collaborative environment  

• Analytical and goal-oriented, with the ability to operate with urgency while maintaining high standards of scientific rigor and ethics  

• Strong communicator who can translate complex toxicology into clear, audience-appropriate risk assessments, from early-stage teams to large pharma partners  

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 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 $228,000 - $280,000. Compensation for the role will depend on a number of factors, including a candidate’s 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 Medicines's good faith estimate as of the date of publication and may be modified in the future.