Clinical Science Liaison, Director-level

Affinia Therapeutics is a clinical-stage biotech company developing next-generation gene therapies. We have a transformational next-generation AAV capsid that we are leveraging to develop first-in-class and best-in-class gene therapies for cardiovascular diseases. We have ambitious plans to make a positive impact in the lives of patients around the world.

You will be working with a team that has a track record of drug approvals in the industry.

Position Summary

Affinia Therapeutics is seeking a Director-level Clinical Science Liaison 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 and operations experience to advance innovative gene therapies in clinical trials and to patients. You will design and operationalize clinical development plans in a biotech environment, collaborating with internal cross-functional teams, contract organizations, and trial sites. You will create, cultivate, and maintain relationships with clinical investigators, medical experts, and 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.

Primary Responsibilities

• Help operationalize the First-in-Human Phase 1b/Phase 2 clinical trial for AFTX-201, our lead program in BAG3-associated dilated cardiomyopathy (BAG3 DCM), by engaging with clinical trial sites and the contract organization to ensure site activation, patient recruitment, and other study activities are completed efficiently and on time in accordance with applicable regulations and guidance.
• Develop and maintain professional relationships with study sites, cultivating thought leaders who are advocates for our company and program.
• Develop and execute a medical communication plan for the program including identification of data gaps, data generation initiatives, and data dissemination plan via presence at scientific conferences and via publications.
• Engage 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 a shared goal of finding better treatments.
• Contribute to the development and implementation of SOPs for clinical studies and related activities, including process for review of grants and scientific content.
• Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with healthcare professionals and with patients.

Minimum Qualifications

• Scientific degree, such as Ph.D., Pharm.D., B.S.N., M.S.N., P.A., or N.P., preferably with clinical care experience.
• Demonstrated hands-on approach in successful clinical development and operations in a biotech environment.
• Minimum 5 years of related work experience, with some experience in First-in-Human studies and in rare diseases or cardiovascular diseases.
• Solid understanding of compliance standards for interactions with healthcare professionals, patients, and patient advocacy groups; clinical trial review processes at institutional IRBs and IBCs; and generally, for trial recruitment and conduct.
• Strong relationship-building skills to build customer rapport and trust, and drive results.
• Strong organizational skills.
• Superb interpersonal, written communication, and oral presentation skills.

This is a remote-based position in a major U.S. city, with up to 40%, domestic/international travel as business needs require.

Equal Opportunity Employer

Affinia is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.