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Affinia Therapeutics · 2 months ago

Director – Vice President, Clinical Development

Waltham, MA

Full-time

Onsite

Director/Executive

$220K/yr - $350K/yr

8+ years exp

Affinia Therapeutics is a cutting-edge biotech company developing next generation gene therapies. They are seeking a Director – Vice President, Clinical Development to lead clinical development plans and advance innovative gene therapies from the laboratory into clinical trials. The role involves collaborating with internal teams and external partners, as well as engaging with the medical community and patients.

BiotechnologyHealth CareLife ScienceTherapeutics

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

Qualification

Clinical Development ExperienceFirst-in-Human StudiesRegulatory KnowledgeCardiology ExperienceRare Diseases ExperienceInterpersonal SkillsWritten CommunicationOral Presentation SkillsOrganizational Skills

Required

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