Director – Vice President, Clinical Development

Affinia Therapeutics•Waltham, MA

52d•$220,000 - $350,000•Onsite

About The Position

Affinia Therapeutics is a cutting-edge biotech company developing next generation gene therapies. We are backed by a strong syndicate of life science investors and strategic partner Eli Lilly and have ambitious plans to dramatically impact the lives of patients around the world. You will be working alongside the executive leadership team which has a successful track record of success of drug approvals and company build. We have a series of transformational next generation AAV capsids that we are leveraging to develop differentiated first in class and best in class gene therapies for cardiovascular and neurological diseases. Our initial focus is on helping patients with BAG3-associated dilated cardiomyopathy, a devastating genetic heart disease affecting tens of thousands of patients worldwide. Position Summary Affinia Therapeutics is seeking a Director – Vice President, Clinical Development, who is enthusiastic about bringing transformative treatments to patients. As a valued leader, you will partner closely with the Chief Medical Officer and bring a high degree of scientific acumen and robust clinical development experience to strategically advance innovative gene therapies from the laboratory into clinical trials and to patients. You will design and implement clinical development plans in a small company environment, collaborating with internal cross-functional teams, and external contract organizations. You will create, cultivate and maintain relationships with clinical investigators, medical experts, as well as other members of the medical, scientific, and patient communities. As a subject matter expert, you will fulfill a critical role that drives substantial clinical contributions to broadening the reach of gene therapy based on the Affinia Therapeutic platform. This position is located at the Affinia Therapeutics site in Waltham, MA with 4 days per week (M-Th) onsite.

Requirements

Academic degree that is clinically oriented such as a Bachelor’s or Master’s degree in Nursing or in Physician Assistant studies; D.O; or M.D.
Clinical experience in treating patients as an N.P.; P.A.; or Physician, preferably in Cardiology.
Minimum 8-10 years of related work experience, or equivalent combination of education and relevant clinical development work, preferably in a biotech environment and/or Cardiology.
Minimum 2 years experience with rare diseases.
Minimum 2 years experience with First-in-Human studies and early clinical development, with record of accomplishment in clinical study design, monitoring, execution, and results analysis and reporting.
In-depth knowledge of clinical development including FDA, EU, and International regulations, and industry best practices.
Experience with documentation systems, document review, and auditing responsibilities.
Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.
Superb interpersonal, written communication, and oral presentation skills.
Strong organizational skills.
Travel up to 30%, Domestic / International as business needs command in future

Responsibilities

Design and execute the First-in-Human Phase 1b/Phase 2 clinical trial for AFTX-201, Affinia’s lead program in BAG3 (BLC2-associated athanogene 3)-associated Dilated Cardiomyopathy, with planned IND submission in Q4 2025 and first patent dose Q1 2026.
Lead the preparation and rollout of clinical protocols and additional critical documents such as the investigator brochure, IND/CTA, integrated clinical and statistical summary reports, and journal articles.
Partner with Regulatory and with Clinical Operations to ensure all regulatory and clinical study activities are completed efficiently and on time in accordance with applicable regulations and guidance.
Review clinical data from all phases of development and lead the generation of study reports, publications, and regulatory documents.
Optimize trial readiness and execution for BAG3-associated Dilated Cardiomyopathy and future indications by proactively identifying and evaluating available tools and datasets, and by strategically fostering research to fill critical gaps including in natural history datasets, registries, clinical outcomes, biomarkers, pathways to rapid genetic diagnosis, observational study protocols and standard of care guidelines.
Engage early with patients, families, researchers and clinicians, to better understand disease burden, needs, meaningful endpoints, acceptable and feasible clinical development strategies and opportunities to partner toward the shared goal of finding better treatments.
Be the primary clinical interface to peers in other functions, and the clinical lead on the program team.
Maintain scientific awareness regarding advances in indications of interest, and in the field of gene therapy; regulatory awareness regarding new guidance and rules, and industry awareness regarding trends and competition through literature, conferences and stakeholder interactions.
Serve as representative for Affinia at scientific, medical, patient, health authority, and public meetings, ensuring that communications are grounded in the latest research and aligned with Affinia positions, and that external communications are consistent with this standard.
Coordinate and provide ongoing assessment, evaluation, and communication with other functions including but not limited to regulatory, clinical operations, translational science, and CMC/manufacturing to ensure study objectives/timelines are met.
Contribute to the development and implementation of SOPs for clinical studies and related activities, as required.
Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
Develop and maintain professional relationships with academic and community-based study sites.