VP / Executive Medical Director - Keros Therapeutics
Lexington, MA
About the Job
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-ß, 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-ß 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.
Keros seeks a Vice President / Executive Medical Director to lead the development of elritercept. Reporting to the SVP of Clinical Development, the VP/Executive Medical Director will serve as the clinical development leader for elritercept (KER-050) in one or more indications. 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 elritercept 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 hematology 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.