Senior Director, Clinical Operations

Your Purpose

Alpha-9 Oncology is seeking a highly motivated Senior Director, Clinical Operations to lead and drive clinical studies in collaboration with Clinical Development. In this role, you will work cross-functionally with Program Management and CMC Operations to define strategy, achieve corporate program targets, mitigate risks, and ensure budget and timeline compliance. As the Clinical Operations team grows, you may have the opportunity to directly supervise and mentor team members while making a meaningful impact in a dynamic and fast-paced environment.

Reporting to the Vice President of Clinical Operations, you will play a pivotal role in shaping clinical trial execution at Alpha-9 Oncology. Your leadership will help drive operational excellence, ensuring our trials are conducted efficiently and in compliance with regulatory standards.

What You’ll Do

• Provide leadership in the development and execution of clinical trial management, budget, and resourcing strategy at a program level.

• Lead the CRO/vendor selection strategy for assigned studies, oversee contracting documentation (SOWs, MSAs, etc.), and ensure robust sponsor oversight and sourcing strategies.

• Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents.

• Oversee the selection of monitoring resources and ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines.

• Provide input on governance documents, SOPs, work instructions, and operational resources to optimize clinical trial execution.

• Build collaborative relationships with internal stakeholders to facilitate trial planning, operational strategy, risk management, and mitigation.

• Provide Clinical Program updates, including trial status/metrics, budget, accomplishments, and risks to the CMO, Program Leaders, Senior Management, and other key stakeholders.

What You Bring

• Bachelor’s degree in Life Sciences; an advanced degree is preferred, with a minimum of 10 years of experience in the pharmaceutical and/or biotechnology industry with a proven track record in managing clinical trials.

• Strong working knowledge of ICH and GCP regulations.

• Experience with selection and oversight of CROs/vendors is required.

• Experience managing early-stage oncology trials; radiopharmaceutical experience preferred.

• Strong ability to prioritize tasks and maintain keen attention to detail.

• Excellent writing, communication, and presentation skills.

• Demonstrated leadership and project management abilities.

• Hands-on, proactive mindset with a willingness to roll up your sleeves and drive results.

• Strong interpersonal skills with the ability to interact effectively at all levels within and outside the organization.

What we Offer

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.