ROLE: Clinical Operations
COMPANY

Octant is a well-backed team of experienced scientists and entrepreneurs at the frontiers of biology, chemistry, and computation. We are a small molecule therapeutics company combining high-throughput synthetic biology, generative chemistry, and AI/ML to repeatedly develop precision medicines for genetically defined diseases.

JOB DESCRIPTION

Octant is looking for an experienced clinical operations leader who is excited to lead and manage our clinical trials. You will be pivotal in driving the execution of our clinical development programs and bringing a first-in-class drug to improve patients' lives. As the first Clinical Operations hire, you will play a critical role in shaping our clinical infrastructure and optimizing processes. You bring strong technical skills in complex program management, excellent communication, and an ability to thrive in a dynamic and fast-paced environment.

AS A PART OF OCTANT'S OPERATIONS TEAM, YOU'LL:

Build and lead a high-performing clinical operations function, fostering a culture of collaboration, accountability and operational excellence across clinical, regulatory, biomarker and CMC teams
Lead global clinical operations for trials spanning multiple regulatory jurisdictions, ensuring regional compliance and site engagement across diverse geographies
Oversee CROs and vendors and all aspects of Phase I through pivotal trials in rare disease indications, trial strategy, site selection, and vendor management, ensuring adherence to the organizational objectives of our drug programs and relevant regulatory requirements, e.g., FDA, EMA, ICH/GCP guidelines
Develop and implement risk assessment and mitigation strategies to proactively address potential challenges in trial execution, ensuring contingency plans are in place for critical study milestones
Establish and track key performance indicators (KPIs) to assess trial efficiency, data integrity, and operational performance, ensuring continuous process improvements
Collaborate with regulatory teams to support agency interactions, including FDA, MHRA and EMA meetings, ensuring trial designs align with regulatory expectations, optimizing for accelerated approval pathways
Develop and drive SOPs and best practices as it relates to the drug development process and facilitate their implementation
Drive patient advocacy and engagement by collaborating with patient groups to enhance trial design, recruitment, and retention
Lead KOL engagement strategy to refine protocols, optimize endpoints, and support regulatory discussions

THIS JOB MIGHT BE GREAT FOR YOU IF YOU:

Have a Bachelor's degree in life sciences, health sciences, nursing, pharmacy, clinical research or a related field, or equivalent experience
Have 10+ years of experience as a clinical operations manager, project manager or related role with hands-on experience managing clinical trials in the biotech-pharmaceutical industry or a clinical research organization
Use your strong project management, organizational and communication skills to strategically manage CROs and vendors to deliver outcomes aligned with the company's overall development goals
Understand the specific challenges associated with ophthalmology research clinical trials and proactively identify and mitigate risks associated with clinical trials
Enjoy working seamlessly across functions
Are detail-oriented and thrive in a fast-paced, collaborative, team-oriented startup environment

Along with your application, please share a summary of a clinical trial you've managed that best highlights your strengths so we can better understand the work you've led. We'd love to also hear about things you've been proud to build or lead outside of clinical trials.

The expected annual base salary for this role is in the range of $165,000 to $235,000, depending on experience level. We offer competitive medical, dental, and vision coverage, equity, and 401(k) matching.

Octant is located in Emeryville, California and we work onsite. Expect to travel up to 25% of the time, 1-2 times per year internationally, to attend investigator meetings and conduct on-site monitoring of clinical trials.

Octant is an equal opportunity company that values applicants of all backgrounds. We're committed to fostering an inclusive and supportive work environment. We value less traditional backgrounds, and may consider an equivalent combination of knowledge, skills, education, and experience to meet minimum qualifications.

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