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Senior Director, Program Management

Aurion Biotech
Cambridge, MA Full Time
POSTED ON 4/18/2025
AVAILABLE BEFORE 5/17/2025

JOB TITLE: Senior Director, Program Management

LOCATION: Cambridge, MA

SALARY RANGE: $261,000 to $293,000. The midpoint of the range is $275,000. The ideal candidate would be hired at or around the midpoint.


ABOUT THE POSITION

Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and it is advancing into Phase 3 clinical trials in 2025. Aurion operates as a separate entity with full support from Alcon.


We are seeking a strategic, experienced, and execution-oriented Senior Director, Program Management to lead cross-functional program planning and execution for our late-stage cell therapy development programs. This individual will play a pivotal role in driving Aurion’s lead asset through registrational studies, regulatory submissions, and preparation for FDA approval and commercialization.


The ideal candidate has a strong background in advanced therapies, including cell and gene therapy, and a proven track record of managing complex programs through the IND, pivotal trials, and BLA submission phases. You will collaborate closely with R&D, Regulatory Affairs, Clinical Development, Manufacturing, Quality, and Commercial teams to ensure strategic alignment and executional excellence.


KEY RESPONSIBILITIES


  • Serve as the program lead for Aurion’s late-stage cell therapy asset, ensuring alignment across all functions and external partners to meet program milestones and regulatory requirements.
  • Build and maintain integrated program plans, timelines, and budgets; proactively identify and manage risks and dependencies.
  • Drive cross-functional team execution, serving as a central point of coordination and communication for program progress, issues, and decisions.
  • Lead planning and delivery of key development milestones, including registrational clinical trials, CMC readiness, and BLA/MAA submissions.
  • Partner closely with Aurion’s Regulatory function to prepare FDA and ex-US regulatory interactions, including pre-BLA meetings and advisory committees, as needed.
  • Ensure effective governance by preparing for and facilitating internal stage gates.
  • Manage relationships with external collaborators, CDMOs, and consultants critical to program execution.
  • Support the transition to commercialization, working with the Commercial, Medical Affairs, and Supply Chain teams to ensure launch readiness.


QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:


  • Advanced degree in a life science, engineering, or related discipline (PhD, MS, MBA, or equivalent experience).
  • Minimum of 10 years of biotech/pharma industry experience, with at least 5 years in program management for advanced therapies (cell, gene, or regenerative medicine).
  • Proven experience leading a therapy from late-stage development through regulatory submission and FDA approval.


REQUIRED SKILLS AND ABILITIES


  • Strong understanding of FDA regulatory pathways, CMC requirements, and clinical operations for cell-based therapies.
  • Exceptional leadership, organizational, and interpersonal skills with the ability to influence without authority.
  • Highly collaborative with a hands-on, problem-solving approach and ability to thrive in a fast-paced, mission-driven environment.
  • Proven experience in establishing a PMO for a life sciences start-up highly preferred.


ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:


  • Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
  • Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
  • Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.


Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com


LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:


  • Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
  • Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
  • Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.


Salary : $261,000 - $293,000

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