Senior Medical Director, Clinical Development Operations

Join Entrada Therapeutics as a Senior Medical Director, Clinical Development Operations. We are a progressive clinical-stage biopharmaceutical company dedicated to transforming the lives of patients through innovative intracellular target engagement. Our unique Endosomal Escape Vehicle (EEV)-therapeutics ensure efficient delivery of various treatments across numerous organs and tissues, significantly enhancing therapeutic effectiveness. Currently, we are advancing our lead oligonucleotide programs for Duchenne muscular dystrophy and partnering on a clinical-stage program for myotonic dystrophy type 1. Our team is a collaborative mix of experts in therapeutic development and rare diseases, and we are excited to expand our team with individuals who share our commitment to making a positive impact on patients and their families. The Opportunity In this pivotal role, reporting to the Senior Vice President of Clinical Development, you will be responsible for spearheading our neuromuscular development programs from early stages through clinical trials. Your expertise will foster strategic alliances with external stakeholders, such as key opinion leaders, while offering valuable clinical insights to your Entrada colleagues. This position is remote, with a preference for candidates based in New England, and requires quarterly visits to our headquarters in Boston, MA. Responsibilities Lead the oversight and management of clinical programs including planning, execution, and completion of trials in adherence with industry regulations (ICH/GCP) and Entrada standard operating procedures. Collaborate with research teams to integrate translational research into clinical development strategies. Partner with Clinical Operations to ensure all activities comply with applicable regulations and standards. Evaluate clinical data from all phases of development, assisting in the creation of study reports and publications. Cultivate and maintain relationships with key opinion leaders and Principal Investigators as the main medical liaison. Act as a representative for Entrada in discussions with regulatory agencies. Provide regular updates to management regarding progress, changes in scope, schedule, and resource allocation. Ensure adherence to global regulatory standards for clinical trials and physician interactions. Build and sustain professional relationships with academic and community-based study sites involved in our clinical development programs. Direction and leadership for internal teams, vendors, and consultants in the preparation of regulatory submission packages and pre-clinical safety data evaluation. Take charge of the clinical content in all regulatory documents, including protocols, INDs, CTAs, investigator brochures, and annual reports. Organize and present at clinical advisory boards, monitoring committees, and scientific meetings, including manuscript and poster preparation. Occasional national and international travel as required. Qualifications Physician (MD/DO or equivalent). Minimum of 3 years of clinical research experience in the industry. Specialization in clinical development focused on Neurology/Neuromuscular disorders. Strong scientific and clinical background. Proven leadership, project management, negotiation, and presentation skills. Comprehensive experience managing clinical trials from inception to completion across various phases. Effective communicator, capable of presenting complex information to diverse teams and senior management. Thorough understanding of FDA and ICH regulations. Expertise in Good Clinical Practice (GCP). Ability to manage multiple projects with strong attention to detail. Skilled in fostering cross-functional relationships and working collaboratively. Proactive problem-solver, capable of addressing issues swiftly and effectively. This position allows remote work, but candidates located in New England are preferred. What We Offer At Entrada, you can expect meaningful work accompanied by competitive rewards and support. We believe in transparency and equity in compensation, and we strive to be open about salary ranges and our compensation philosophy in line with applicable state requirements. We offer comprehensive benefits, including health, dental, and vision coverage; life and disability insurance; a 401(k) match; paid parental leave; education reimbursement; discretionary time off; and commuting benefits. If you prefer to work at our Boston office, you will be situated near the city's vibrant offerings. Your contributions are significant to our mission, and at Entrada, we recognize that meaningful work deserves meaningful rewards. Our compensation strategy reflects our commitment to collaboration, curiosity, and dedication. Salary range: $328,000 - $387,000; final compensation will depend on your skills, experience, and other lawful factors. Equal Opportunity Employer Entrada Therapeutics is an equal opportunity employer. We ensure that qualified candidates receive consideration without discrimination based on race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, disability, marital status, citizenship status, military status, protected veteran status, or any other protected category. Third Party Staffing Agencies Entrada does not accept unsolicited resumes from recruitment agencies. Resumes will only be accepted under an agreement for a specified position. Privacy Statement Entrada respects your privacy. Please refer to our privacy statement to understand how and when your information is utilized.