Medical Director at Keros Therapeutics

Job Summary:              

The Medical Director will be a key medical and scientific leader for one or more clinical programs in the neuromuscular therapeutic area. The ideal candidate will be a physician with therapeutic area expertise, medical monitoring experience, and a general understanding of clinical drug development within the biopharmaceutical industry. The role requires medical and scientific oversight along with hands-on participation in all aspects of clinical trial execution, ensuring the safety of trial participants and the scientific integrity of the data collected.  The Medical Director will also lead and participate in teleconferences with study Investigators, advisory meetings with key opinion leaders (KOLs), and interactions with Health Authorities, as indicated. A genuine interest in learning and understanding the science supporting the pipeline, 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 in this role.                                                 

Primary Responsibilities

Medical and Scientific Oversight for Clinical Trials

• Provide medical leadership and expertise to cross-functional study teams, guiding the clinical development of one or more neuromuscular programs.
• Guide development of therapeutic area, protocol, and investigational product training as required for efficient and effective trial execution.
• Serve as the main point of content for medical and scientific questions about the protocol and/or investigational product arising from Investigators, clinical research associates, vendor partners, and other clinical trial stakeholders.
• Communicate trial progress, risks, and emerging data insights to internal project teams and senior leadership, as appropriate.
• Lead trial-related committees such as a Safety Review Committee, Data Safety Monitoring Board, Steering Committee, etc. when appropriate for the trial design.
• Lead authoring clinical trial protocols and amendments, annual updates to the Investigator's Brochure, and Clinical Study Reports. Additionally, guide and/or review required documents and study plans for clinical trial start-up and execution.
• Serve as the clinical and scientific expert for clinical trial applications and other regulatory submissions.

Medical Monitoring and Participant Safety

• Ensure the safety of trial participants and the scientific integrity of studies by serving as the primary Medical Monitor (MM) or overseeing outsourced MM responsibilities.
• Perform real-time review of clinical trial data in conjunction with the cross-functional team including clinical science, safety, clinical operations, and data management.
• Provide prompt medical advice to Investigators and site staff regarding management of adverse events and unforeseen circumstances for clinical trial participants.
• Collaborate with the Drug Safety and Pharmacovigilance team to ensure timely and accurate safety reporting to regulatory authorities. 

External and Internal Collaboration

• Engage with KOLs, clinical experts, and Investigators to ensure the clinical development plan reflects the latest scientific and medical guidelines.
• Engage with the neuromuscular scientific community and relevant advocacy groups to ensure trial designs are appropriate and patient centric. 
• Represent the company at scientific conferences, advisory board meetings, and regulatory interactions.
• Foster strong, collaborative relationships with internal stakeholders, including clinical operations, regulatory affairs, biostatistics, and commercial teams. 

Development Strategy

• Contribute to creating and executing the overall clinical development plan for assigned assets, providing therapeutic area expertise and engaging in strategic discussions.
• Participate in business development activities by conducting evaluations of in- and out-licensing opportunities, when relevant to therapeutic area expertise. 

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. 

Experience

• Minimum of 3 years of clinical practice experience; completion of a subspecialty fellowship fulfills this requirement.
• Minimum of 3 years of clinical drug development experience in the biopharmaceutical industry.
• Direct experience with the roles and responsibilities of a MM as detailed above, with a proven track record of navigating complex clinical trials or equivalent complex and multifaceted clinical management situations.
• Direct experience with pediatric and rare indication clinical trials is preferred.
• Experience in the neuromuscular or rare disease therapeutic area 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 desire to learn will be considered.
• Strong strategic and analytical thinking skills with ability to anticipate, prevent, and solve complex drug development challenges.
• Excellent verbal, written, and presentation communication skills, with the ability to convey complex scientific information to various audiences.
• Proven leadership skills, with the ability to influence without direct authority and thrive in a fast-paced, small biotech environment.
• A high level of emotional intelligence and the ability to build collaborative, cross-functional relationships.