Vice President, Head of Hematology Clinical Development
Company: American Society of Hematology
Location: Cambridge
Posted on: November 17, 2023
Job Description:
ASH Job Center: Vice President, Head of Hematology Clinical
Development
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- FAQs Home / Vice President, Head of Hematology Clinical
Development Company/Institution: Fulcrum Therapeutics Location:
Cambridge, MA, USA Degree Requirements: MD, DO Salary: Not
available Job Type: Employers at #ASH23, Research, Other Posted:
November 15, 2023 Job Setting: Corporate (Biotech or
Pharmaceutical) Application Period: November 15-December 15, 2023
Fulcrum Therapeutics is seeking an experienced VP, Head of
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, Head of
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
- MD or equivalent with 10+ years of
pharmaceutical/biotech-industry clinical development experience.
Therapeutic expertise in hematology while not essential 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
independently.
- Strong analytical, decision-making, project management and
problem-solving skills. About the Employer 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 two lead programs in clinical
development are losmapimod, a small molecule for the treatment of
facioscapulohumeral muscular dystrophy (FSHD) and FTX-6058, a small
molecule designed to increase expression of fetal hemoglobin for
the treatment of sickle cell disease and other hemoglobinopathies,
including beta-thalassemia. The company's proprietary product
engine, FulcrumSeekTM, identifies drug targets that can modulate
gene expression to treat the known root cause of gene
mis-expression. Contact InformationTodd Cogdell
26 Landsdowne Street
Cambridge, MA 02139 USA
www.fulcrumtx.com
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Keywords: American Society of Hematology, Cambridge , Vice President, Head of Hematology Clinical Development, Healthcare , Cambridge, Massachusetts
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