Director/Senior Director, Program Management

Affinia Therapeutics is an innovative gene therapy company with a vision to create a paradigm shift by broadening the reach of gene therapy to prevalent diseases. Our proprietary Affinia Rationally-designed Therapies (ART) platform was created to address key efficacy, safety, and cost of goods limitations of conventional gene therapies. We are backed by a strong syndicate of life science investors. Our purpose is to have a dramatic impact on the lives of patients around the world.

You will play a key role in shaping our culture and embodying our values of integrity, passion, and teamwork. You will be working alongside the founding management team who have a track record of success in the industry. The pace of work is dynamic, fast, and fun.

We offer competitive salary and benefits with the ability to make a difference.

Position Summary

Affinia Therapeutics is seeking a highly motivated individual to join us as a Program Manager (job level will commensurate with experience) to drive efficient execution of our programs from preclinical development into clinical trials. The Program Manager will function as project lead for multiple programs, initially spanning genetic cardiomyopathies and CNS indications.  The function will lead project teams and will bring scientific input, regulatory and clinical information together. The Program Manager will provide project status updates and participate in strategic decisions together with the management team.

This position is based out of our facilities in Waltham, MA with 4 days per week (M-Th) in the office.

Primary Responsibilities

• Program Leadership: Lead cross-functional program teams to achieve program objectives, milestones, and deliverables in alignment with corporate goals.
• Strategic Planning: Develop and implement strategic plans for the successful execution of drug development programs, including timelines, budgets, and resource allocation.
• Cross-Functional Collaboration: Foster collaboration and communication among internal stakeholders, including research, development, regulatory affairs, clinical and manufacturing teams.
• Risk Management: Proactively identify potential risks and issues impacting program timelines or objectives and develop mitigation strategies to ensure successful execution.
• Regulatory Compliance: Ensure that all program activities adhere to regulatory requirements and guidelines, collaborating closely with Regulatory Affairs to support successful regulatory submissions.

Minimum Qualifications

• Bachelors degree in life sciences or related field; advanced degree (e.g., MBA, PhD) preferred.
• Minimum of 8-10 years of experience in pharmaceutical or biotechnology industry, with at least 5 years of experience in program management or related roles.
• Proven track record of successfully leading cross-functional drug development programs from early-stage research through Phase II.
• Strong understanding of drug development processes, including preclinical, clinical, regulatory, and manufacturing requirements.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across teams and at all levels of the organization.
• Demonstrated ability to thrive in a fast-paced, dynamic environment, managing multiple priorities and adapting to changing business needs.
• Experience working in a matrix organization and leading teams in a collaborative, cross-functional setting.

 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.