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Executive Director, Clinical Sciences

Company: Keros Therapeutics
Location: Lexington
Posted on: November 18, 2023

Job Description:

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 strategy.

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 international travel.
Essential Functions/Responsibilities

  • Lead the Clinical Sciences group and directly supervise Keros' Clinical Scientists
  • 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 plan.
  • Provide clinical sciences leadership on the timely delivery of the clinical program with attention to quality and scientific rigor.
  • 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 CDP.
  • 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 platform.
  • 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 publication.

    Key Qualifications
    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 critical.

    • 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 preferred.
    • 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 community.
    • 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 monthly.
    • 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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