Provide medical oversight and strategic leadership throughout the clinical trial lifecycle, including the design, planning, execution, and interpretation of trials for investigational compounds, ensuring patient safety and scientific integrity.
Contribute to the design and development of key clinical documents, including study protocols, investigator’s brochures, informed consent documents, and other essential materials.
Ensure the clinical development strategy adheres to industry best practices and regulatory guidelines while collaborating with study investigators and medical experts in the development and execution of study protocols.
Lead the review and interpretation of clinical trial data, including safety assessments, efficacy endpoints, and overall trial progress.
Serve as a key medical expert in cross-functional discussions, including regulatory submissions, investigator meetings, and advisory boards.
Work with the Clinical Operations team to identify and resolve trial-related issues, ensuring smooth execution and compliance.
Collaborate closely with the clinical operations, regulatory, and data management teams to ensure timely and high-quality execution of clinical trials.
Collaborate with the research team to develop and implement a translational biomarker strategy for the program integrating early-phase data to inform clinical strategy.
Contribute to regulatory submission efforts by providing clinical insight into IND submissions, clinical trial applications, and other regulatory documents support responses to health authorities and ethics committees.
Represent the company at scientific conferences, advisory boards, and meetings with regulatory authorities.
Develop and maintain relationships with external stakeholders, including key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).
Foster a collaborative and positive team environment that encourages innovation, scientific rigor, and high-performance standards.
Travel to clinical sites, conferences, and regulatory meetings as needed.
Other duties as assigned.

Requirements

Medical Doctor must be board eligible or certified in a medical specialty relevant to the role or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
U.S. trained physicians must have achieved board eligibility or certification.
Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).
Clinical or research experience in cardiology or endocrinology
At least 7 years of relevant experience.
At least 2 years of experience overseeing the execution of clinical trials, preferably within an industry setting; ideal candidate might have experience with gene therapy/editing programs or early phase clinical development
Strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices.
Proven ability to interpret clinical trial data, experience serving as medical monitor on a clinical trial, including safety assessments and efficacy endpoints, and apply it to inform decision-making.
Leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders.
Excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings.
Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).
Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus.
Ability to travel to clinical sites, conferences, and regulatory meetings as needed.
Collaborative mindset, fostering innovation, scientific rigor, and high performance in a team setting.
Strong problem-solving skills with the ability to resolve trial-related issues and ensure smooth execution.

Benefits

eligibility to participate in a company-sponsored 401(k)
pension
vacation benefits
eligibility for medical, dental, vision and prescription drug benefits
flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
life insurance and death benefits
certain time off and leave of absence benefits
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial designregulatory requirementsGCP guidelinesclinical trial data interpretationsafety assessmentsefficacy endpointsgene therapyclinical developmenttranslational biomarker strategyIND submissions

Soft Skills

leadershipcollaborationcommunicationpresentationrelationship developmentproblem-solvinginnovationscientific rigorteamworkcross-functional collaboration

Certifications

Medical Doctorboard eligibilityboard certification