Sr. Director, Clinical Science

ALX Oncology Inc.•South San Francisco, CA

1h•$305,000 - $325,000•Hybrid

About The Position

The Senior Director, Clinical Science will advance the clinical development of ALX2004 at ALX Oncology. The role combines scientific expertise and hands-on execution, including clinical trial monitoring, development of clinical and regulatory strategies, analysis and interpretation of trial data, and authorship of study protocols and key regulatory documents. The Senior Director works with the medical lead, cross-functional internal teams, CROs, and external investigators globally, taking ownership of key deliverables and contributing to day-to-day clinical development activities. The position is based at the company’s South San Francisco, California corporate office and follows a hybrid work model. The company prefers applicants who can regularly work onsite Mondays and Tuesdays. Domestic and international travel may be required up to 25% of the time. Applicants authorized to work in the U.S. without sponsorship are encouraged to apply.

Requirements

PhD or MD.
Minimum 10 years of clinical research experience in oncology clinical development within the biotechnology and/or pharmaceutical industry.
Extensive hands-on experience with day-to-day medical monitoring of clinical trials, including patient eligibility questions, review of clinical safety parameters, and receiving, evaluating, and processing serious adverse events (SAEs) and IND expedited safety reports.
Strong scientific understanding of oncology, internal medicine, and clinical pharmacology, applicable to trial design, monitoring, and interpretation of clinical data.
Demonstrated experience authoring clinical study protocols, interpreting clinical trial data, and preparing clinical sections of regulatory submissions.
Experience in clinical development of biologic and/or small-molecule therapies.
Strong working knowledge of FDA and EMA requirements and expectations, GCP, ICH guidelines, and clinical drug development processes.
Strong organizational skills and attention to detail, with the ability to manage multiple priorities, maintain accurate documentation, and meet deadlines.
Ability to work independently, exercise sound scientific judgment, adapt to changing priorities, and recognize when cross-functional input or escalation is needed.
Excellent written and verbal communication and interpersonal skills, with the ability to work effectively across internal functions, CROs, and external clinical investigators.
Proficiency with Microsoft Outlook, PowerPoint, Word, and Excel.
Ability to travel domestically and internationally up to 25% of the time, as required.

Nice To Haves

Experience with Spotfire, interactive voice response systems (IVRS), and electronic data capture (EDC) systems.
Ability to regularly work onsite Mondays and Tuesdays as part of the company’s hybrid work model.

Responsibilities

Provide trial monitoring for Phase 1, 2, and 3 trials with ALX and CRO medical monitors, including ongoing evaluation of clinical and safety data.
Author clinical study protocols, amendments, related documents, and electronic case report forms (eCRFs) with the program lead and/or medical lead.
Work with Clinical Operations, study management teams, CROs, and other functions to develop study timelines, resolve issues, and execute clinical trials.
Coordinate integrated safety monitoring activities with study management teams, CROs, and Pharmacovigilance.
Review, analyze, and interpret clinical trial data; work with data management teams on data integrity, cleaning, database lock, and analyses for study reporting and regulatory filings.
Plan and contribute to reporting and publication of company-sponsored clinical trials, including clinical study reports, scientific presentations, and publications.
Lead development and authorship of clinical sections of regulatory submissions, including Investigator’s Brochures, safety updates, IND/BLA submissions, and responses to Health Authority questions.
Collaborate with Research and Preclinical Development scientists on regulatory submissions and activities, including Breakthrough Therapy and Fast Track designation requests, pre-IND activities, and IND submissions for new drug candidates.
Provide clinical and scientific input into study quality, regulatory compliance, and safety oversight, ensuring trial activities follow Good Clinical Practice (GCP) and applicable regulatory requirements.
Develop and maintain relationships with oncology investigators to strengthen clinical study design, execution, reporting, and publication.
Participate in trial-related advisory boards and investigator meetings, and lead protocol training sessions.
Support other Clinical Development and organizational priorities as needed.
Contribute to a culture of integrity, accountability, transparency, and respect, and build collaborative relationships through active engagement, including regular onsite participation consistent with the hybrid work model.