Senior Medical Director

Job Summary:              

Keros is searching for a Senior Medical Director to drive clinical development of the lead asset in its clinical pipeline. This Senior Medical Director will be a key medical and scientific leader for rinvatercept development in the neuromuscular therapeutic area, including Duchenne’s muscular dystrophy (DMD) and amyotrophic lateral sclerosis (ALS). The ideal candidate will be a physician with neuromuscular therapeutic area expertise and deep experience in clinical development, regulatory strategy, key opinion leader (KOL) engagement, and trial execution. The Senior Medical Director will primarily function to lead clinical development strategy for rinvatercept, including development of the clinical development plan (CDP), and working within the cross-functional Program Team to ensure effective risk identification and mitigation, and keep planned clinical development activities on track. The Senior Medical Director will also be a key advisor/author for regulatory submissions and will be leading advisory meetings with KOLs and interactions with various health authorities. The role requires medical and scientific oversight of ongoing clinical trials (hands-on participation in aspects of clinical trial execution may be required) to ensure the scientific integrity of the data collected.  This is a leadership position best-served by an articulate communicator with a teaching acumen and the gravitas necessary for high-stakes engagements. A genuine interest in learning and understanding the complex science supporting the pipeline is essential. An ability to work collaboratively in a highly matrixed multidisciplinary team setting, and a commitment to developing new treatments for patients in need, are critical for success. This Boston-based role has a flexible hybrid work arrangement requiring 3 days a week in the Lexington, MA office.                                                   

Primary Responsibilities

Development Strategy

• Lead clinical development strategy for rinvatercept, including development of the CDP and designing future clinical trials, via working within the cross-functional Program Team to ensure strategic alignment.
• Contribute to program-level risk identification and mitigation, contributing the clinical development perspective and offering creative solutions to identified problems.
• Provide necessary oversight and hands-on execution to ensure rinvatercept clinical development activities are delivered with up-front quality and within planned timelines.
• Serve as the key advisor/author for relevant sections of regulatory submissions and associated documents, including queries and requests for information.
• Represent Keros in face-to-face and written interactions with various health authorities.
• Participate in business development activities when requested by speaking as the rinvatercept clinical development expert an/or by conducting evaluations of in-licensing opportunities aligned with therapeutic area expertise.

Medical and Scientific Oversight for Clinical Trials

• Provide medical leadership and expertise to cross-functional study teams, guiding the aligned execution of rinvatercept clinical trials in accordance with strategic goals.
• Communicate trial progress, risks, and emerging data insights to internal teams and senior leadership, as appropriate.
• Lead or supervise trial-related committees such as a Safety Review Committee, Data Safety Monitoring Board, Steering Committee, etc. when appropriate for the trial design.
• Provide oversight for authoring of protocols, amendments, annual updates to the Investigator's Brochure, data publications, and final clinical study reports.

External and Internal Collaboration

• Lead advisory meetings with KOLs to guide clinical development strategy and ensure study designs and CDPs are aligned with the evolving therapeutic area landscape and are appropriately balancing patient centricity and research needs.
• Foster strong, collaborative relationships with internal cross-functional stakeholders and represent the Program Team in delivering clinical development recommendations to senior leadership, when appropriate. 

Qualifications

Education

• M.D., D.O., or equivalent medical degree is required.
• Board eligibility or certification in Neurology, Pediatric Neurology, or a related field is desired. 
• Strong working knowledge of good clinical practice (GCP), various clinical development pathways, and regulatory special designations, is expected.

Experience

• Minimum of 5 years of clinical drug development experience in the biopharmaceutical industry is required; experience with Phase 3 design and biologics license application (BLA) drafting will be a plus.
• At least 3 years of clinical practice experience is preferred; completion of a subspecialty fellowship fulfills this requirement.
• Direct experience with the roles and responsibilities of a trial medical lead is required; applicants should demonstrate a track record of successfully navigating complex clinical trials and global clinical development challenges.
• Direct experience with pediatric and/or rare indication clinical trials is desired; experience with neuromuscular clinical trials is preferred.

Skills and Attributes

• Exceptional medical and scientific knowledge of neuromuscular disorders is desired; however, a proven track record of learning new indications along with strong scientific acumen and curiosity will be considered.
• Strategic and analytical thinking skills are necessary; an ability to anticipate, prevent, and creatively solve complex drug development challenges is essential for success.
• Excellent verbal, written, and presentation communication skills are required; a demonstrated ability to convey complex scientific information to various audiences through presentations, publications, and teaching experience is desired.
• Leadership and the ability to influence without direct authority are necessary; candidates should be able to provide specific examples where their leadership influenced drug development decisions.
• A high level of emotional intelligence and the ability to build collaborative, cross-functional relationships are essential. 
• Ability to work on-site in the Lexington, MA office at least 3 days a week is required.