Vice President, Hematology Clinical Development

2 weeks ago

Cambridge, United States Fulcrum Therapeutics, Inc. Full time

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 unique insights that we've gained from our approach have resulted in several new discovery programs that have emerged from FulcrumSeek, our proprietary connectivity map database and target identification platform, which are currently being prioritized and advanced. The company has advanced losmapimod to Phase 3 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD).Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development.

Job Description

Fulcrum Therapeutics is seeking an experienced VP, Hematology Clinical Development to join the clinical development organization to provide medical/scientific expertise to advance our innovative product candidates in our non-malignant hematology pipeline, including the continued clinical development of FTX-6058.

In this role, you will lead the clinical design and conduct for assigned studies or programs, direct KOL engagement and be the medical lead on multi-disciplinary clinical teams. The VP, Hematology Clinical Development will manage, develop, and oversee early-stage clinical development programs by working closely with the Chief Medical Officer, VP of Clinical Development, other internal stake holders (such as Pre-clinical, Clinical Operations, Biostats, Regulatory) and other external networks (vendors, KOLs, etc.), to drive the design, planning, and implementation of clinical program/s and study protocols in all phases of development.

This clinical development expert may also support regulatory and pharmacovigilance activities, and corporate goals, by contributing clinical, scientific and development expertise to all business development initiatives. The leaders at Fulcrum Therapeutics model our culture and our patient-focused core values. This leader will be expected to work collaboratively with others across multiple disciplines to deliver key biological insights that drive our discovery efforts Fulcrum's culture and patient-focused core values.

Responsibilities

* Lead and oversee early and late-stage clinical development plans, including design, author, and execute clinical trials for Fulcrum's clinical programs across development phases to ensure execution of high-quality clinical trials that meet key milestones, maintain timelines, and stay within budget.
* Provide clinical leadership to support development and advancement of preclinical assets.
* Provide clinical leadership in preparation of clinical protocols, regulatory documents, and regulatory agency interactions, including an active presence in internal governance and review committees.
* Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data, safety and efficacy trials.
* Establish strong external networks of thought leaders in collaboration with members in clinical, medical affairs and R&D, to support clinical development strategies and help optimize program plans and protocols.
* Participate in Fulcrum's outreach to patients and their families, and in interactions with patient advocacy groups and their representatives.
* Represent Fulcrum and present data at key national and international conferences.
* Contribute actively to the Clinical Development leadership team, relevant governance bodies, and process improvement initiatives.

Qualifications

* M.D. or D.O. with 10+ years of pharmaceutical/biotech-industry clinical development experience.
* Therapeutic expertise in non-malignant hematology a must.
* Prior experience with clinical protocol development and study conduct in biotech or pharmaceutical companies
* Excellent interpersonal and collaborative skills
* Superior communication and facilitation ability
* Proven ability to influence, persuade, and lead others.
* Self-motivated critical thinker with the ability to work independently.
* Strong analytical, decision-making, project management and problem-solving skills.
* This position is hybrid (50% in office) and will be primarily located in Cambridge, MA

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