Director, Clinical Development, Medical Monitoring Lead

Role Summary

Director, Clinical Development, Medical Monitoring Lead overseeing neuromuscular development programs and other pipeline programs from early stages through clinical trials, ensuring patient safety and building external partnerships. This role reports to the Sr. Vice President of Clinical Development and involves cross-functional collaboration, strategic oversight, and leadership in medical monitoring.

Responsibilities

• Lead medical monitoring/reporting and safety activities in partnership with clinical sites and CROs.
• Act as the medical contact at the company for clinical/medical issues for ongoing studies.
• Interpret and report on results of clinical studies, in partnership with other internal study stakeholders for all phases of development.
• Participate or lead in safety review meetings and provide clinical input into adverse event evaluation and reporting.
• Support or lead clinical program design activities, including planning, execution, and completion of clinical trials according to applicable regulations and guidance (ICH/GCP) and Entrada SOPs.
• Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH/GCP, and Entrada SOPs.
• Develop and maintain relationships with key opinion leaders and Principal Investigators.
• Provide management with timely updates on progress and changes in scope, schedule, and resources as required.
• Ensure compliance with regulatory standards related to global clinical trials and interactions with physicians.
• Develop and maintain relationships with academic and community-based study sites involved in clinical development programs.
• Support clinical content of all clinical and regulatory documents (protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSR, ISS, ISE, and clinical expert reports).
• Support clinical advisory boards, data monitoring committees and medical/scientific meetings, including collaboration in manuscripts, posters, and other scientific communications.
• Travel nationally and internationally, as needed.

Qualifications

• MD/DO or equivalent with board certification preferred.
• 2+ years of industry and/or clinical/clinical research experience.
• Direct experience serving as a medical monitor within rare disease clinical studies.
• Strong scientific background.
• Experience communicating/presenting key/complex information to department/functional leads/senior management.
• Strong knowledge of FDA and ICH regulations.
• Expert knowledge of Good Clinical Practice (CGP).
• Ability to multi-task and manage several projects in parallel with attention to detail.
• Ability to forge cross-functional relationships with internal teams and external partners, and work collaboratively.
• Proactive problem-solving to identify and resolve trial implementation hurdles.
• US-based remote position, with preference for local New England candidates; travel to Boston HQ required monthly/quarterly.

Skills

• Medical monitoring and safety reporting
• Clinical trial design and regulatory compliance (ICH/GCP, FDA)
• Stakeholder management and cross-functional collaboration
• Scientific communication and presentation
• Relationship building with KOLs, Investigators, and sites
• Strategic thinking and proactive issue resolution

Education

• MD/DO or equivalent; board certification preferred