Associate Director, Clinical Affairs

JOB TITLE: Associate Director, Clinical Affairs

Reports To: Executive Director, Clinical Development

LOCATION: Remote - candidates must be based in one of the following states to be considered: IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, or WA.

SALARY RANGE: $174,000 to $200,000. The midpoint of the range is $185,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

Aurion Biotech is seeking an experienced and motivated Associate Director, Clinical Affairs to serve as a bridge between Clinical Operations, Clinical Development, and Medical Affairs. In this role, you will provide operational and support for clinical development initiatives. You will ensure cross-functional alignment by translating clinical development goals into actionable plans, supporting regulatory interactions, and contributing to investigator and site training efforts. 

KEY RESPONSIBILITIES

• Collaborate with cross-functional teams to assist in the design of clinical studies that generate meaningful evidence for stakeholders.
• Develop clinical study documents including protocols, ICFs, investigator brochures, and clinical reports and contribute to ongoing regulatory documents such as annual reports, DSURs, etc. 
• Work closely with clinical operations, to ensure studies are executed on time, within scope, and in compliance with GCP and regulatory standards.
• Review safety information and perform medical reviews of patients participating in clinical trials to ensure adherence to protocols and regulatory requirements
• Oversee data collection, ensuring integrity and accuracy, and applying statistical methods to interpret results. 
• Develop strong relationships with investigators, KOLs, and clinical sites to support patient enrollment and data quality.
• Collaborate with medical and regulatory teams to support submissions, including IDEs, PMAs, and global filings.
• Contribute to clinical publications, abstracts, and presentations at scientific conferences.
• Provide clinical guidance and support to cross-functional project teams throughout the development lifecycle.
• Support the development of clinical SOPs, processes, and infrastructure to scale the clinical affairs function.

QUALIFICATIONS AND EDUCATION

• Bachelor’s degree in life sciences required; advanced degree (e.g., MS, PhD, MD) preferred.
• 7+ years of experience in clinical development or clinical affairs in the pharmaceutical, or biotech industries. 
• Experience in designing and supporting clinical trials in ophthalmology is required.
• Strong knowledge of clinical research methodologies, FDA/ICH-GCP regulations, and regulatory requirements for clinical studies.
• Excellent writing skills and experience developing clinical study documents and regulatory submissions.
• Effective communicator with strong interpersonal skills and the ability to influence across departments.
• Organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
• Commitment to quality, compliance, and continuous improvement.
• A strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values.

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.

QUALIFICATIONS AND EDUCATION

• Bachelor’s degree in life sciences required; advanced degree (e.g., MS, PhD, MD) preferred.
• 7+ years of experience in clinical development or clinical affairs in the pharmaceutical, or biotech industries. 
• Experience in designing and supporting clinical trials in ophthalmology is required.
• Strong knowledge of clinical research methodologies, FDA/ICH-GCP regulations, and regulatory requirements for clinical studies.
• Excellent writing skills and experience developing clinical study documents and regulatory submissions.
• Effective communicator with strong interpersonal skills and the ability to influence across departments.
• Organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
• Commitment to quality, compliance, and continuous improvement.
• A strong alignment with, and commitment to, Aurion Biotech’s mission, vision, and core values.