Associate Medical Director, Gene Therapy Clinical Development - Cardiology

Role Summary

Associate Medical Director, Gene Therapy Clinical Development - Cardiology. Lead, develop, and manage clinical studies in cardiovascular gene therapy, building and maintaining relationships with investigators and key opinion leaders. Ensure medical and scientific integrity of trials, oversee patient wellbeing, and maintain compliance with internal and external standards while proactively mitigating risk. Report to the Chief Medical Officer.

Responsibilities

• Performs medical monitoring on one or more clinical trials: provides study-related medical information and assistance, including medical questions from investigators and site personnel, safety findings and adverse event oversight, and audits or inspection medical responses.
• Lead medical data review on clinical trials with colleagues on an ongoing basis.
• Provide clinical/medical input to support protocol development; lead protocol amendments and related documents.
• Provide clinical/medical input to data collection tool development (e.g., EDC) and other related tools.
• Oversee, approve, and update Informed Consent Forms, including responses to external stakeholder questions.
• Provide clinical/medical input to the Integrated Quality Management Plan.
• Establish Data Monitoring Committees (DMCs) and endpoint adjudication committees; oversee charter development, committee presentations, and documentation of outcomes.
• Input, review, and approve Risk Management Plan and Safety Review Plan; collaborate with stakeholders to implement mitigations.
• Review and approve country/site selection criteria; contribute to authoring of site training materials.
• Serve as primary contact with external investigators and internal study team for clinical/medical protocol questions.
• Review and manage protocol deviations; ensure TMF compliance for clinical documents.
• Input and review Clinical Study Reports; support disclosure of safety and efficacy data and trial conclusions; contribute to primary publication of results.
• May contribute to regulatory filings (PIP, IB, IND/NDA annual reports, DSURs) if required; may support responses to regulatory queries and CTAs.
• Contribute to continuous process improvement and innovative approaches to maximize trial effectiveness.

Qualifications

• Required: MD/DO or equivalent from a recognized medical school/university; 3–5 years of relevant academic/industry experience.
• Required: Cardiology training.
• Required: Deep understanding of the science and genetics underlying cardiomyopathy and heart failure.
• Required: Familiarity with clinical research and innovative imaging technologies in cardiovascular disease research (e.g., echocardiography, MRI, PET) and related cell signaling systems.
• Required: Ability to work collaboratively as part of a multi-functional drug development team in a dynamic environment.
• Required: Self-motivated, highly organized, detail-oriented, able to multi-task and deliver high-quality work.
• Required: Excellent oral and written communication skills; strong interpersonal skills with ability to influence and work cross-culturally and cross-functionally.
• Preferred: Clinical Research experience in industry/CRO.
• Preferred: Scientific writing skills and a track record of publications, posters, abstracts, or presentations.
• Preferred: Knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

Skills

• Medical monitoring and safety management in clinical trials
• Protocol development and amendment leadership
• Data collection tools and EDC systems
• Informed consent and regulatory documentation
• Risk management and safety planning

Education

• MD/DO or equivalent medical degree