Location: Cambridge, MA

Department: Business Development

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 Associate Director (AD), Program Management will be a strategic leader responsible for driving cross-functional drug development programs from early research through clinical development and potential commercialization. This individual will partner with the VP or Program Strategy and Functional leads to ensure alignment on program strategy, execution of key deliverables, risk management, and resource planning. The AD will play a critical role in enabling effective communication & decision-making, ensuring the organization meets its scientific, clinical, and business objectives.

Key Responsibilities

• Serve as the primary program manager for one or more development programs, overseeing timelines, budgets, and deliverables across functions (R&D, Clinical, Regulatory, CMC, Commercial, etc.).
• Partner with Program lead to define program strategy, milestones, and decision points, ensuring alignment with corporate goals.
• Lead cross-functional program team meetings, driving effective communication, issue resolution, and proactive risk management.
• Develop and maintain integrated project plans, including scenario planning and contingency strategies.
• Prepare executive-level updates, dashboards, and reports for senior leadership, governance committees, and the Board as appropriate.
• Facilitate decision-making and governance processes, ensuring timely escalation of risks and issues.
• Partner with Finance and functional leads to track program budgets and resource allocation.
• Mentor and coach junior program managers and contribute to the build-out of best practices, tools, and processes for program and portfolio management.
• Contribute to portfolio-level planning, prioritization, and long-range strategy.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree (PhD, PharmD, MBA, or equivalent) strongly preferred.
• 7+ years of relevant experience in biotechnology or pharmaceutical industry, with at least 5+ years of program management experience in drug development.
• Demonstrated track record of successfully managing cross-functional drug development programs through major milestones (e.g., IND, FIH, Ph2, pivotal studies, regulatory filings, launch).
• Strong understanding of drug development process, including preclinical, clinical, CMC, regulatory, and commercial considerations.
• Excellent leadership, interpersonal, and communication skills; ability to influence without authority.
• Proven ability to develop and maintain complex project plans and budgets, and to manage risks proactively.
• Experience presenting to executive leadership, governance committees, and external stakeholders.
• Highly organized, detail-oriented, and comfortable operating in a fast-paced, dynamic biotech environment.
• Evaluate, customize, and deploy software / tools to improve efficiency and effectiveness of our project management and knowledge management capabilities
• We offer a hybrid work environment. Team members are expected to be onsite half of the time of the time (50%) to support collaboration and connection.

Preferred Attributes

• Prior experience in rare disease, oncology, or gene therapy strongly preferred.
• PMP or other project management certification a plus.
• Demonstrated ability to build and scale program management capabilities in a growing organization.

Location: Cambridge, MA

Department: G&A

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).

Overview:

The Contracts Manager works with members of the legal team to provide legal assistance for: contract development, negotiation, clinical study start-up, support of the IP function, corporate governance, enterprise risk management, and general administrative legal tasks. As a dedicated legal partner, you will interact with leadership and other stakeholders from various cross-functional teams.

To be successful in this role you must be a strong collaborator, a flexible thinker, someone who appreciates the strength of a team, possess strong communication skills, the power of a positive mindset, and the ability and willingness to value and respect differences.

Key Responsibilities:

• Review, interpret, negotiate, and draft a high volume of wide range of agreements, including those related to clinical trials, and quality study-related agreements such as: clinical trial agreements, investigator initiated study agreements, and material transfer agreements;
• Drive increased efficiency, coordination, and effectiveness of contracts processes and support to meet the needs of the business and other key stakeholders;
• Utilize strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance issues and risks associated with contract terms and other activities within areas of responsibility, and work with attorneys to formulate and communicate compliant and practical solutions that meet business objectives;
• Communicate with business partners regarding the risks presented by contract terms and possible strategies to mitigate such risks;
• Work within Fulcrum’s contracts management system and develop a high degree of proficiency, which will include training others on using the system;
• Assist with fact-gathering to support legal advice;
• Develop and deliver presentations and training on legal and contracts-related topics as needed;
• Assist the IP lead with tasks such as patent assignments and the scientific publication process;
• Provide assistance to the Chief Legal Officer in the implementation of the Enterprise Risk Management process;
• Establish strong business partnership relationships characterized by a high-level of collaboration, trust, and mutual respect;
• Develop, implement, and maintain contract playbooks, templates, and processes;
• Review of study start-up documents and various client presentations;
• Other projects and assignments based upon work needs; and

Qualifications:

• 8+ years of experience negotiating agreements related to pre-clinical and clinical research (international experience a plus) as a legal assistant, paralegal, or in a contracts role in a legal or procurement-type department supporting clients in the pharmaceutical/biotech industry;
• Self-motivated, a good listener, collaborative, responsible, flexible, and have excellent attention to detail;
• Handle confidential and proprietary information using discretion and sound judgment;
• Strong written and oral communication skills;
• Strong organization skills and demonstrated ability to manage multiple projects as well as working and meeting deadlines in a fast paced environment with a high degree of accuracy and efficiency is critical in this role;
• Excellent customer service skills, with an ability and willingness to develop and nurture strong relationships with colleagues and key stakeholders to advance project goals and objectives;
• Proactively identify opportunities to develop and implement improved processes and to maximize efficiency of the Legal team.
• Problem-solver with an eagerness to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex issues and challenges;
• Ability and willingness to work both independently and as team player;
• Capable of delivering difficult messages and providing recommendations with tact, poise, and diplomacy;
• Proficient in MS Word, Excel, and PowerPoint;
• Ability to influence without authority, as well as lead and manage multiple projects, in a fast-paced, evolving environment;
• Consistently take action and drive issues to closure and hold self and others accountable for achieving results;
• Strong collaborator and adept at understanding the motivation and needs of others and effectively communicating with a diverse audience, including senior leaders, in a manner that generates confidence and support for proposals/recommendations;
• Legal analysis is well thought out and accurate, potential legal and compliance issues are consistently identified;
• Minimum of Bachelor’s Degree preferred, but not required with significant work experience related to clinical research in a contracts role in a legal or procurement-type department supporting clients in the pharmaceutical/biotech industry.
• We offer a hybrid work model, with employees expected to be onsite at least 50% of the time.

Location: Cambridge, MA

Department: Regulatory Affairs and QA

Company Overview

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving 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 expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. The company’s proprietary product engine identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.

Description

The Director, Head of Medical Writing, will report to the Head of Regulatory Affairs & Quality Assurance and collaborate cross-functionally with colleagues in Discovery, Clinical Development, Medical Affairs, and Regulatory. This individual will lead the development and delivery of a broad range of clinical and regulatory, documents to support the company’s drug development programs.

Initially, this role will oversee an outsourced model for medical writing activities. Over time, the Director will be responsible for building and managing an internal medical writing team that is appropriately resourced to meet the evolving needs of the organization. The ideal candidate will combine hands-on writing expertise with strategic leadership to ensure timely delivery of high-quality documents.

Responsibilities

Strategic Leadership & Operational Execution

• Develop and implement a scalable, fit-for-purpose medical writing delivery model that balances internal and external resources
• Lead the planning, preparation, and review of high-quality clinical, regulatory, and publication documents in collaboration with cross-functional teams
• Ensure consistency, accuracy, and compliance with applicable regulatory and scientific guidelines and standards
• Serve as a subject matter expert in medical writing and provide direct writing support as needed

Document Ownership

Clinical Documents:

• Investigator Brochures
• Protocol Synopses, Protocols, and Amendments
• Informed Consent Forms
• Clinical Study Reports (CSRs), Safety Narratives

Regulatory Documents:

• Annual Reports, Safety Updates
• Briefing Documents, Regulatory Correspondence
• Clinical Trial and Marketing Applications in eCTD format, including INDs, CTAs, NDAs/sNDAs, MAAs

Qualifications

• PhD in biological science is preferred
• Minimum of 10 years of medical writing experience in the biopharmaceutical industry or CRO setting
• Proven leadership experience managing teams of full-time employees and/or contractors
• Deep knowledge of GCP, ICH, and CFR regulatory requirements; familiarity with Health Canada, MHRA, PMDA, and EMA guidelines
• Proficiency in scientific literature research methods; familiarity with AMA, APA, CSE, and Chicago style guides
• Understanding of publication guidelines including GPP2, ICMJE, and CONSORT
• Strong technical proficiency with tools such as Adobe Acrobat Pro, Microsoft Office Suite (Word, Excel, PowerPoint, Teams, Project, SharePoint), and EndNote
• We offer a hybrid work model, with employees expected to be onsite at least 50% of the time.

Location: Cambridge, MA

Department: Operations

Company Overview

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic diseases, and is developing a pipeline of clinical and preclinical assets. Fulcrum’s lead clinical asset is Pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. Fulcrum’s preclinical pipeline includes a novel small molecule treatment for Inherited Bone Marrow Failure Syndromes, as well as novel approaches for the potential treatment of other rare hematologic diseases. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Technical Operations team.

Description

Reporting to the CSO, the Head of Technical Operations is responsible for leading and directing all chemistry, manufacturing, and controls (CMC) activities for our clinical stage products, as well as establishing our clinical and commercial supply chain infrastructure. The qualified individual will co-develop our CMC strategy with their team of direct reports, including establishing controls and supply chains suitable for a global launch. This individual will represent TechOps on cross-functional project teams, and routinely present to the Executive Team and Board of Directors.

Key Responsibilities

• Provide executive and strategic leadership of manufacturing and supply strategies
• Together with your team and with colleagues in Quality and Reg CMC, co-develop phase-appropriate CMC strategies and tactics for our development candidates, including Ph1/2 and Pivotal stage assets
• Implement tactical plans aligned with corporate strategies to ensure that immediate and longer-term drug substance and drug product deliverables are met
• Develop and manage approaches to forecasting to ensure product supplies are on time and in location, and meet the needs of Clinical Operations
• Hire, lead and develop employees to successfully meet our objectives while balancing a highly externalized model.
• Develop strategies for commercial supply that are appropriate for a global launch in major markets, and that take into consideration a dynamic geopolitical climate
• Together with team, work closely with external manufacturing partners to ensure reliable, compliant execution against production schedules; monitor, and report performance indicators to highlight progress, risks, and mitigation strategies.
• Together with your team and colleagues, ensure performance of manufacturing sites in process validation and inspection readiness activities.
• Communicate operational status regularly to senior management and program teams

Qualifications

• M.S. or PhD in pharmaceutics preferred, or in engineering, chemistry, or analytical chemistry; MBA desirable
• Proven track record of developing phase-appropriate and timely control strategies for DS and DP, including the establishment of commercial supply chains with serialization and 3PL (or at minimum highly conversant in packaging and distribution strategies through commercial launch)
• Prior experience leading small molecule CMC activities within an emerging pharma environment
• Skilled in strategy, planning, and execution, and in the clear communication of CMC strategy and tactics to diverse audiences, including project teams and senior management
• Can serve as a thought partner/resource with colleagues in Quality and Reg CMC
• Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment; responds to stress with humor and professionalism
• Some travel required