VP/Executive Medical Director

Keros Therapeutics; Lexington (MA); On-site; USD 200,000 - 350,000; Full time

Job summary

Keros Therapeutics is seeking a Vice President/Executive Medical Director to spearhead the clinical development of their neuromuscular asset. This leadership role involves guiding cross-functional teams, overseeing regulatory submission processes, and representing clinical development in high-level interactions. Candidates should possess an MD or DO, with significant experience in clinical trial management and an understanding of drug development.

Qualifications

• Minimum of 7 years Pharmaceutical/Biotech industry experience.
• Experience leading late-stage clinical trials.
• Understanding of global regulatory processes.

Responsibilities

• Lead the development of KER-065 in neuromuscular indications.
• Collaborate with cross-functional teams on clinical protocols.
• Engage with regulatory authorities and stakeholders.

Skills

Leadership

Problem-Solving

Communication

Education

MD or DO

Job description

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At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

JOB SUMMARY:

Keros seeks a Vice President / Executive Medical Director to lead the development of our neuromuscular asset. Reporting to the CMO, the VP/Executive Medical Director will serve as the clinical development leader for KER-065. She/he will serve as the lead physician in internal and external interactions with key stakeholders and will be the lead clinical development representative on internal project teams to support clinical studies from protocol development through study execution and completion of study reports. The VP/Executive Medical Director will collaborate with cross-functional team members, including Clinical Sciences, Clinical Operations, Program Management, Biostatistics and Data Management, Safety and Pharmacovigilance, DMPK/Clinical Pharmacology and CRO partners. The VP/Executive Medical Director will also lead and participate in meetings with academic study investigators and thought leaders, as well as in interactions with global health authorities. A genuine interest and understanding of the science supporting the pipeline, excellent leadership skills, an ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and a commitment to developing new treatments for patients are critical for success.

Responsibilities:

• Serve as the lead physician and Development Leader and represent Clinical Development on Program and Project Strategy Teams for KER-065 in one or more indications.
• Collaborate with the Project Team Leader(s) and other team members to create and revise the Clinical Development Plan (CDP) for successful global regulatory approval and market access for one or more indications.
• Lead the design of scientifically rigorous clinical protocols that are aligned with the clinical development plan.
• Provide clinical development leadership on the timely delivery of the clinical program with attention to quality and scientific rigor.
• Lead and support the clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including INDs/CTAs, BLAs/MAAs and regulatory responses) with high quality and consistency with the CDP.
• Oversee the Medical Monitor and work in concert with the Head of Safety to ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection.
• Collaborate with biostatistics, clinical sciences, and other cross-functional team members to participate in relevant data analyses and presentations for safety monitoring committee meetings, regulatory documents, and internal reviews to support timely program decisions to achieve study objectives.
• Lead and/or participate in interactions with internal decision committees and external stakeholders including regulatory authorities, key thoughts leaders, data monitoring committees, advisory boards, and patient advocacy groups.
• Lead and participate in the periodic convocation of Steering Committee meetings.
• Work with the internal team and external stakeholders 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 the scientific communication of clinical data, including external messaging, publication planning, and congress management.
• Work with investigators, thought leaders, patient advocacy groups, and other external stakeholders, as appropriate, to foster scientific exchange, identify collaboration opportunities, recruit patients for clinical trials, and support commercial planning, including understanding of medical and health care practices.
• Represent the company as an organization and present data at advisory boards, investigator meetings, congresses, and other external venues.
• Author and review abstracts, posters, and manuscripts for publication.
  
  
  

Qualifications:

• MD or DO required, board certification/eligibility in neuromuscular and/or rare disease is highly desired.
• Minimum of 7 years Pharmaceutical/Biotech industry experience, including experience leading late-stage clinical trials and clinical development programs.
• Global clinical research experience and experience interacting with global health authorities is required; successful End-of-Phase 2 and/or NDA/BLA experience is highly desired.
• Deep understanding of clinical trial design, methodology, statistical concepts, protocol development and implementation, global regulatory submissions, and overall drug development.
• Knowledge of IND, End-of-Phase 2, and BLA/NDA processes.
• Track record of success in serving as a clinical development leader on cross-functional product teams.
• Experience with partnerships or responsibilities for interfacing with development and commercial partners.
• Outstanding leadership, problem-solving, organizational and communication skills.
• Ability to be in the company office at least 3 days per week (local candidates) or at least every 6 weeks (remote candidates) required.
• 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.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

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