Senior Manager, Clinical Scientist (Hybrid)

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 proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum is also advancing FTX-6058 to phase1, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia.

Description

The Senior Manager, Clinical Scientist will work closely with the medical director(s) to provide support in one or more Clinical Project Teams at Fulcrum Therapeutics in order to ensure the successful design and implementation of Clinical Development Plans. This role serves to ensure the design of cost-efficient clinical trials to meet the needs of internal and external stakeholders.

S/he is responsible for effective scientific oversight of studies (in partnership with study / program medical director and clinical operation team members) and supports appropriate interpretation and communication of clinical trial data (including high quality regulatory submission). Major areas of responsibility include contributing to clinical trial design and execution of Company-sponsored clinical trials at all phases of development, clinical trial data analysis, internal and external communication of project plans and progress, safety monitoring and mitigation, and key contributions to regulatory submissions, publications, and clinical data communications.

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

Skills & Qualifications

• PhD, or PharmD is highly desired

• At least 5+ years of Clinical Scientist experience in the biotechnology/pharmaceutical industry

• Experience in rare diseases is a plus

• Comprehensive knowledge of the drug development process is preferred

• 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%)

Base Salary Pay Range
$150,000—$190,000 USD