Medical Director, Sickle Cell Program
Company: Fulcrum Therapeutics, Inc.
Posted on: June 7, 2021
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). 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.
Fulcrum Therapeutics is seeking an experienced hematology
medical director to join the clinical development organization to
provide medical/scientific expertise to advance our innovative
product candidates in the sickle cell disease program.
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 Medical
Director 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
- 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 in preparation of clinical
protocols, regulatory documents, and regulatory agency
interactions, including an active presence in internal portfolio
- 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 and R&D, to support
clinical development strategies and help optimize program plans and
- Represent Fulcrum and present data at key national and
- Contribute actively to the Clinical Development leadership
team, relevant governance bodies, and process improvement
- MD or equivalent with 3+ years of
pharmaceutical/biotech-industry clinical development experience.
Therapeutic expertise in hematology is strongly desired
- 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
- Strong analytical, decision-making, project management and
Keywords: Fulcrum Therapeutics, Inc., Cambridge , Medical Director, Sickle Cell Program, Other , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!