Director, Clinical Science Liaison (U.S. & Canada)

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

• Drive and ensure professional and upbeat partner relationships with on- site Clinical Study Team for Affinia Therapeutics First-in-Human Phase 1b/Phase 2 clinical trial for AFTX-201, our lead program in BAG3-associated dilated cardiomyopathy (BAG3 DCM).

• Lead engagement with eleven clinical trial sites (domestic/international) to ensure site activation, patient recruitment, and other clinical study activities are completed efficiently and on time in accordance with applicable regulations and guidance.

• Maintain a high-level of scientific knowledge, communication and understanding about the disease state, underlying science, treatment guidelines, and lead program guidance. Drive the timely dissemination of accurate and compliant clinical information as it emerges to external partners.

• Oversee and deliver clinical education supporting internal/external clinical development engagement strategy and ensure scientific priorities are met with clear and articulate communication with site Study Team partners.

• 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.

• Contribute to patient recruiting and enrollment activities to assist over-arching patient recruitment and retention goals

• Cultivate KOL’s who are advocates and congresses for Affinia Therapeutic’s program/s.

• 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 7-10 years of related field-based work experience, with some experience in First-in-Human studies and in rare diseases or cardiovascular diseases preferred.
• 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 (U.S. & Canada) 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.