Executive Director, Clinical Sciences
Company: Keros Therapeutics
Posted on: November 18, 2023
Executive Director, Clinical Sciences
at Keros Therapeutics
(View all jobs)
Lexington, MA (Hybrid)
Keros Therapeutics is a public, clinical-stage biopharmaceutical
company focused on the discovery, development, and
commercialization of novel treatments for patients suffering from
hematological and musculoskeletal disorders with high unmet medical
need. We are a leader in understanding the role of the transforming
growth factor-beta, or TGF-, family of proteins, which are master
regulators of red blood cell and platelet production as well as of
the growth, repair and maintenance of muscle and bone. We have
leveraged this understanding and developed a discovery approach to
generate large and small molecules to address diseases of these
tissues. Targeting TGF- signaling pathways has been clinically
proven to elicit robust changes in blood cells, muscle, and bone,
which we believe provides a precedent and strong rationale for our
Reporting to the SVP of Clinical Development, the Executive
Director, Clinical Sciences will serve as the leader of the
Clinical Sciences group and will directly supervise the company's
Clinical Scientists. In addition, she/he will serve as the lead
Clinical Scientist for the KER-050 program in myelodysplastic
syndromes (MDS) and myelofibrosis (MF), including strategic
planning and implementation. She/he will represent the KER-050
development team with key internal and external stakeholders to
support clinical studies from protocol development through study
execution and completion of study reports. The Executive Director
will collaborate with cross-functional team members, including
Clinical Development, Clinical Operations, Program Management,
Biostatistics and Data Management, Safety and Pharmacovigilance,
DMPK/Clinical Pharmacology and CRO partners. This position is based
in the company's Lexington office and requires some domestic and
- Lead the Clinical Sciences group and directly supervise Keros'
- Function as the lead Clinical Scientist for the KER-050 program
and serve on Program and Product Strategy Teams.
- Contribute to the creation and revision of the Clinical
Development Plan (CDP) for successful global regulatory approval
and market access for one or more indications for KER-050.
- Partner with the Project Team Leader(s) and other team members
to develop and execute on the clinical strategy.
- Contribute to the design of scientifically rigorous clinical
protocols that are aligned with the clinical development
- Provide clinical sciences leadership on the timely delivery of
the clinical program with attention to quality and scientific
- Lead and support creation of key documents (e.g., Clinical
Trial Protocols, Investigator's Brochures, Clinical Study Reports
(CSRs), regulatory documents including INDs/CTAs, NDAs/MAAs and
regulatory responses) with high quality and consistency with the
- Collaborate with biostatistics, clinical development, and other
applicable team members to participate in relevant and timely data
analyses and presentations for safety monitoring committee
meetings, regulatory documents and internal reviews to support
timely program decisions regarding study objectives.
- Participate in interactions with internal decision committees
and external stakeholders including regulatory authorities, key
opinion leaders (KOLs), data monitoring committees, advisory
boards, patient advocacy groups.
- Work with the internal team to develop and update key messages
on disease states, MOA, target product profile, and scientific
- Collaborate with Medical Affairs and other team members on
scientific communication of clinical data, including external
messaging, publication planning, and congress management.
- Author and review abstracts, posters, and manuscripts for
To succeed in this role, the candidate must have a genuine interest
and understanding of the science supporting the pipeline, an
ability to work collaboratively in a highly matrixed,
multidisciplinary team setting, and an innovative drive to help the
organization to succeed and develop new therapies for patients with
unmet medical needs. In addition, strong leadership and
communication skills and proven proficiency in understanding,
analyzing, and presenting scientific and clinical data are
- Doctorate (MD, PhD, PharmD or equivalent) required; experience
developing therapies for MDS, MF or other hematologic disorders is
preferred, but not required. Late-phase (Phase 2 and 3)
hematology/oncology clinical trial experience is
- Minimum of 7 years of clinical development experience in the
pharmaceutical or biotechnology industry is required.
- Detailed understanding of all aspects of clinical trial design,
methodology, statistical concepts, protocol development and
implementation, global regulatory submissions, and overall drug
development is required.
- Working knowledge of the IND/NDA process is required. Direct
experience with NDA/BLA filings is preferred.
- Strong managerial experience with an ability to attract,
develop, motivate, and retain key talent is required.
- Proven ability to influence diverse stakeholder groups
internally and externally, including executive leadership, study
investigators, KOLs, and the external medical and scientific
- In-depth, strategic understanding of how scientific, clinical,
commercial, business, and other considerations come together to
create successful products.
- Outstanding analytical, problem-solving, organizational,
communication and negotiation skills.
- Ability to be in the office at least 2-3 times per week for
those that are local. For those working remotely, travel to the
company office for 3 days is expected at least once
- Ability to travel up to 20% required.
Our Diversity, Equity & Inclusion Mission Statement:Keros is an
inclusive company. We believe that diversity drives innovation. We
continue to build an inclusive culture that encourages, supports,
and celebrates the diverse voices of our employees. As such, Keros
takes a holistic approach in mentoring, coaching, and developing
all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex including sexual orientation and
gender identity, national origin, disability, protected veteran
status, or any other characteristic protected by applicable
federal, state, or local law.
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Keywords: Keros Therapeutics, Boston , Executive Director, Clinical Sciences, Executive , Lexington, Massachusetts
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