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Director and Head of roles sit at the top of H-1B visa specialty occupation classifications, where your employer must file a Labor Condition Application certifying your wage meets the DOL prevailing rate for a senior-level position. Most sponsoring employers target candidates who can clear USCIS's specialty occupation bar and demonstrate managerial authority tied to a directly related degree field.
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Get Access To All JobsWhat 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.
This role can be onsite at our Cambridge, MA site. Or if you are over 30 miles away remote with travel 3-4 days per month.
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 - $310,000. 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.
Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact privacy@flagshippioneering.com.
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.
This role can be onsite at our Cambridge, MA site. Or if you are over 30 miles away remote with travel 3-4 days per month.
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 - $310,000. 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.
Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact privacy@flagshippioneering.com.
See all 55+ H-1B Visa Director Head Of Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Director Head Of Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Director Head Of
Map your degree to the role
USCIS requires your degree field to directly relate to the Director or Head of role, not just leadership broadly. Document how your academic background underpins the specialized function you'll oversee, not just your years of management experience.
Target employers with cap-exempt status
Universities, nonprofit research institutions, and government-affiliated organizations are cap-exempt, meaning your H-1B can be filed any time without entering the lottery. Director-level roles at these organizations often carry faster timelines and no April registration window.
Verify the LCA wage level before negotiating
Director and Head of positions typically fall at DOL wage Level III or IV. Use OFLC Wage Search to look up the prevailing wage for your occupation code and metro area before you enter salary discussions so you know the H-1B floor your employer must meet.
Search Migrate Mate for verified sponsoring employers
Filter by Director or Head of job titles on Migrate Mate to see which employers have active LCA filings for senior leadership roles. This lets you target companies with a documented history of H-1B sponsorship at the director level, not just general hiring activity.
Request premium processing before your offer deadline
USCIS premium processing guarantees a 15-business-day adjudication window. For Director hires, where start-date commitments are often tied to board approvals or fiscal calendars, asking your employer to file Form I-907 prevents months of uncertainty after the lottery.
Prepare for a specialty occupation RFE at the director level
USCIS sometimes issues Requests for Evidence questioning whether a Director role genuinely requires a specific bachelor's degree rather than general business acumen. Your employer should include the job description, organizational chart, and O*NET occupation profile in the initial petition to reduce that risk.
H-1B Visa Director Head Of: Frequently Asked Questions
Do Director and Head of roles qualify as H-1B specialty occupations?
Yes, if the position requires at least a bachelor's degree in a specific field directly related to the duties. Senior leadership titles alone don't guarantee qualification. USCIS looks at whether the functional work, not just the seniority, demands specialized theoretical knowledge. Roles overseeing engineering, finance, product, legal, or technical teams typically qualify more cleanly than general management positions.
How do I find employers who sponsor H-1B visas for Director-level roles?
Migrate Mate lets you filter by job title and displays verified DOL Labor Condition Application filing history for each employer. This tells you whether a company has actually sponsored H-1B holders at the director level before, which is a stronger signal than whether they list sponsorship as a benefit in a job posting.
Can my employer file my H-1B after I start in the Director role on another status?
Yes, if you're currently authorized to work in the U.S. on a different status, such as OPT or an L-1 visa, your employer can file a concurrent or change-of-status H-1B petition. The timing matters because your existing authorization must remain valid through the H-1B approval or the October 1 start date, whichever applies to your case.
What wage level should my employer use for an H-1B Director position?
Most Director and Head of roles fall under DOL wage Level III or Level IV, which represent experienced and fully competent workers with supervisory responsibility. Your employer determines the level using OFLC Wage Search based on your occupation code, geographic location, and the actual duties in the job description. Filing at an artificially low level is a common audit trigger.
Does H-1B sponsorship get harder if I move into a broader Head of role mid-visa?
A material change in duties, title, or worksite requires your employer to file an amended H-1B petition with USCIS before or when the change occurs. Moving from a functional director role to a broader Head of organization position can trigger the amendment requirement, especially if the occupation code or wage level changes alongside the expanded scope.