WE ARE RARE
Fulcrum is a great place to have a career. Why? Because we have the FULcrew! Our people make us great. At Fulcrum, you can count on finding coworkers who are passionate about their work. Our patient-centered, inclusive, and connected culture enables us to actively listen to the needs of the rare disease community as we lead our science. This makes us and our work rare!
Make your career a career with impact.
See our available roles below or connect with us at careers@fulcrumtx.com
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Meet the FULcrew and hear our stories.
Are you looking for consistency, commitment, and passion in your career? Join us.
There is always hope for change when people are committed to moving forward together every day, without exception. We call this steadfast commitment our "20 Mile March," inspired by Jim Collins' book Good to Great. At Fulcrum, we pledge to show up passionately every day, dedicated to our work and each other, no matter the challenges we face.
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Associate Director, Regulatory Affairs
About Fulcrum Therapeutics
Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).
Description
Reporting to the Executive Director Regulatory Affairs, this role will provide strategic leadership and support on regulatory submissions, manage global regulatory timelines, and ensure compliant and efficient execution of regulatory activities across development stages and product lifecycles. The ideal candidate will have an understanding of global regulatory requirements (FDA, EMA, ICH, etc.), hands-on experience in electronic submissions, and a collaborative mindset to drive cross-functional success. The ideal candidate will be eager to assist with building the regulatory organization within a growing clinical stage company.
Responsibilities
- Oversee planning, preparation, review, tracking and submission of high-quality regulatory dossiers (e.g., INDs, CTAs, NDAs, MAAs).
- Provide guidance to cross-functional teams to ensure submissions comply with applicable regulations, standards, and agency guidance, including clinical, nonclinical, CMC, and commercial stakeholders.
- Coordinate responses to CTA queries from regulatory authorities (e.g., FDA, EMA, MHRA, Health Canada, TGA), when required.
- Track regulatory questions, commitments, and timelines using internal systems and ensure timely escalation of issues.
- Coordinate publishing, formatting, and archiving of submissions and regulatory correspondence in compliance with internal SOPs and health authority requirements.
- Liaise with external vendors to manage regulatory timelines, document control, and submission logistics using industry-standard publishing tools.
- Act as the primary liaison with internal submission teams, external vendors, and regulatory authorities for operational matters.
- Oversee the archiving of regulatory submissions and correspondence and serve as administrator of the Regulatory Information Management system.
- Contribute to process improvements and best practices for regulatory submissions.
Qualifications
- Bachelor’s Degree required, with degree in the sciences preferred. Master’s degree preferred.
- Minimum 8 years of experience in the pharmaceutical or biotech industry; at least 3 years’ experience, or working closely with a CRO, with IND/CTA/NDA/MAA submissions.
- Expertise in regulatory operations including eCTD submissions, regulatory publishing tools, and document management systems.
- Able to successfully manage and prioritize complex projects to deadlines with relative independence; organized and adaptable to address conflicting deadlines in a dynamic drug development environment.
- Demonstrated attention to detail and follow-through on assigned activities.
- Outstanding interpersonal and communication (written and verbal) skills; demonstrates calm, professional, diplomatic and positive behaviors.
- Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment.
- Strong computer skills and highly proficient in MS Office applications and Adobe Acrobat
Director/Senior Director, Head of Publications
About Fulcrum Therapeutics
Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).
Position Summary
The Head of Publications will be responsible for leading the development and implementation of Fulcrum’s global publication strategy —including original scientific manuscripts, abstracts, and materials for scientific and patient advocacy audiences. This role will also oversee the timely and high-quality dissemination of clinical and health economics and outcomes research (HEOR) data, as well as the company’s representation across social media platforms.. Reporting to the Vice President, Clinical Development, this role will work cross-functionally with Clinical Development, Medical Affairs, and Regulatory teams to align publication activities with corporate and scientific communication objectives.
This is a hybrid role based in Cambridge, MA, requiring a minimum of 3 days on-site per week.
Key Responsibilities
- Develop and execute a comprehensive global publication strategy, ensuring alignment with Fulcrum’s scientific and medical objectives.
- Lead the planning, development, and dissemination of high-quality scientific publications, including manuscripts, abstracts, posters, and congress presentations.
- Collaborate cross-functionally with Clinical Development, Medical Affairs, and other key stakeholders to ensure a cohesive and strategic approach to data communication.
- Manage external agencies, writers, and vendors, ensuring publications adhere to timelines, budgets, and industry standards (ICMJE, GPP, etc.).
- Drive innovative approaches to scientific publications, including digital platforms and emerging communication channels.
- Ensure compliance with ethical, legal, and regulatory guidelines, including transparency and data-sharing requirements.
- Establish and oversee an efficient publication review process, maintaining scientific integrity, accuracy, and alignment with corporate messaging.
- Track and report key publication metrics to assess impact, optimize strategy, and drive continuous improvement.
- Provide leadership and mentorship to internal team members, fostering professional development and scientific excellence.
Qualifications
- Advanced degree (PhD, PharmD, MD, or equivalent) in a relevant scientific discipline.
- Minimum of 10 years of experience in medical publications within the biotech or pharmaceutical industry, ideally in rare diseases with focus on basic, translational and clinical research in benign and malignant hematology.
- Strong understanding of the publication process, industry guidelines, regulatory, scientific and GCP requirements.
- Track record of publications ideally related to basic, translational, and clinical research in benign and malignant hematology or rare genetically defined disease, featured in high-impact journals and presented at leading scientific meetings.Established network with leading KOLs and other key stakeholders relevant to the successful execution of a publication strategy.
- Experience and ability to plan and translate scientific literature into documents appropriate for non-scientific audiences, including patient advocacy groups, government affairs, and investors.
- Proven track record of developing and executing successful publication plans across multiple therapeutic areas.
- Experience working in a matrixed environment and leading cross-functional teams.
- Excellent communication and project management skills, with the ability to manage multiple priorities effectively.
- Experience with digital publication platforms and innovative publication strategies is a plus.
- Demonstrated ability to manage external vendors and publication budgets effectively.
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