Fulcrum Therapeutics · 2 months ago
Senior Manager, Clinical Scientist
Cambridge, MA
Full-time
Onsite
Senior Level
$150K/yr - $180K/yr
5+ years expFulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases. The Senior Manager, Clinical Scientist will work closely with medical directors to design and implement Clinical Development Plans, ensuring effective oversight of clinical trials and communication of data.
BiotechnologyGeneticsHealth CareTherapeutics
Responsibilities
Support medical director on developing the clinical development strategy
Collaborating with patient advocacy groups, external investigators, and other stakeholders on Natural History and biomarker studies
Contributing to the design of clinical trials and writing/review of protocol concepts, full study protocols, and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
Support the organization of expert panels and advisory board meetings to provide input into the clinical plan, study design or data
Leading action-oriented, project team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes
Anticipating risks and managing/mitigating them with the Medical Director, Project Manager and other team functions as appropriate
Oversight for the conduct of clinical trials by making sure all clinical activities are carried under GCP compliance
Selection of appropriate CRO partners for diverse aspects of study execution
Delivering high quality presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
Providing guidance and/or training for external personnel/parties involved in clinical studies
Clinical study data review, data cleaning and performing analyses in conjunction with Biometrics
Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct
Monitoring for analyses of emerging safety/tolerability
Provide education support for internal company stakeholders
Provide input and support to the Fulcrum Product Engine/Research and Discovery as needed
Work collaboratively with the translational medicine group on the identification, selection, and validation of biomarkers to support the clinical development plans
Facilitate, assist and/or participate in the preparation of clinical study manuscripts with Investigators, internal personnel, and medical writers
Maintain expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and translational teams
Contribute to achieving Fulcrum’s clinical development objectives
Qualification
Required
PhD, or PharmD is highly desired
At least 5+ years of Clinical Scientist experience in the biotechnology/pharmaceutical industry
Proficient knowledge of GCP/ICH, study design, statistics and clinical operations is required
Proven experience with clinical data review databases
Excellent verbal, written, communication and interpersonal skills. Must be able to effectively communicate and collaborate across functions and job levels
Proven scientific writing skills, with strong inter-personal written/ verbal communication skills, including ability to evaluate, interpret and present complex data
Creativity and/ or ability to put innovative approaches into practice in clinical development
Strong sense of teamwork; ability to lead team activities
Exemplary critical thinking, problem solving and decision-making skills
Adaptable, flexible, willingness to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
Potential for travel (up to 20%)
Preferred
Experience in rare diseases is a plus
Comprehensive knowledge of the drug development process is preferred
Company
Fulcrum Therapeutics
Fulcrum Therapeutics is a biotechnology company that focuses on identifying and treating rare genetic diseases at their root cause.
51-200 employees
H1B Sponsorship
Fulcrum Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (5)
2022 (1)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$778.3MKey Investors
Foresite CapitalGoogle VenturesThird Rock Ventures
2025-12-10Post Ipo Equity· $175M
2023-01-17Post Ipo Equity· $125M
2022-08-15Post Ipo Equity· $75M
Leadership Team
Alan A. Musso
Chief Financial Officer
Jeff Jacobs
Chief Scientific Officer and Head of Technical Operations
Recent News
2025-12-11
Company data provided by crunchbase