Sr. Director, Clinical Science

ALX Oncology; South San Francisco (CA); Hybrid; USD 305,000 - 325,000; Full time

Benefits offered by this job

Stock options

Performance bonus

401(k) plan

Comprehensive benefits

Job summary

ALX Oncology seeks a Senior Director of Clinical Science to advance ALX2004 and drive clinical development strategy. You will monitor trials, author protocols, and manage regulatory documents, closely collaborating with medical leads and CROs.

In this hybrid role, you will own key deliverables, interpret complex data, plan regulatory submissions, and contribute to publications while supporting the broader clinical program in a fast-paced biotech setting.

Qualifications

• PhD or MD with 10+ years oncology clinical development experience.
• Hands-on medical monitoring of trials, SAEs and expedited safety reports.
• Strong oncology knowledge and clinical pharmacology understanding.
• Experience authoring protocols and regulatory submissions.
• Experience with biologic and/or small-molecule therapies.
• Knowledge of FDA/EMA, GCP, ICH guidelines and regulatory processes.
• Excellent written and verbal communication with cross-functional teams.

Responsibilities

• Provide trial monitoring for Phase 1–3 trials with CRO medical monitors.
• Author clinical study protocols, amendments and eCRFs.
• Develop study timelines with operations and CROs for trials.
• Coordinate safety monitoring with Pharmacovigilance teams.
• Interpret trial data and support regulatory filings.
• Contribute to reporting and publications of ALX Oncology trials.
• Lead regulatory submission sections with the program/medical leads.
• Collaborate on Breakthrough/Fast Track designations and IND activities.
• Ensure compliance with GCP and regulatory requirements.
• Engage oncology investigators to strengthen study design and reporting.
• Participate in advisory boards and protocol training sessions.

Skills

Trial monitoring

Regulatory submissions

Clinical study design

Data interpretation

Cross-functional collaboration

GCP/ICH knowledge

Leadership experience

Education

PhD/MD with 10+ years oncology clinical development

Tools

eCRF development

Spotfire

IVRS

EDC systems

Job description

The Senior Director, Clinical Science, will play a key role in advancing the clinical development of ALX2004. This position combines scientific expertise with hands‑on execution, including trial monitoring, development of clinical and regulatory strategies, analysis and interpretation of clinical trial data, and authoring of study protocols and key regulatory documents. Working closely with the medical lead, internal cross‑functional teams, CROs, and external investigators globally, the Senior Director will take ownership of key deliverables and contribute directly to the day‑to‑day execution of clinical development activities. This is an opportunity to have a meaningful impact on ALX Oncology's clinical programs in a dynamic, fast‑paced biotechnology environment.

Preference will be given to applicants who can regularly work onsite Mondays and Tuesdays as part of the company's hybrid work model. Applicants who are authorized to work in the U.S. without sponsorship are encouraged to apply.

Key Responsibilities include:

• Provide trial monitoring for Phase 1, 2, and 3 clinical trials in collaboration with ALX and CRO medical monitors, including ongoing evaluation of clinical and safety data.
• In collaboration with the program lead and/or medical lead, author clinical study protocols, amendments, and related documents, including the development of electronic case report forms (eCRFs).
• Work directly with Clinical Operations, study management teams, CROs, and other functions to develop study timelines, resolve issues, and execute assigned clinical trials.
• Partner with study management teams, CROs, and Pharmacovigilance to coordinate integrated safety monitoring activities throughout the study.
• Review, analyze, and interpret clinical trial data, working closely with ALX and CRO Data Management teams on data integrity, data cleaning, database lock, and analyses required for study reporting and regulatory filings.
• Plan and contribute to the reporting and publication of ALX Oncology‑sponsored clinical trials, including clinical study reports, scientific presentations, and publications.
• Lead the development and authoring of key clinical sections of regulatory submissions, including Investigator's Brochures, safety updates, IND/BLA submissions, and responses to Health Authority questions in collaboration with the program lead and/or medical lead.
• Collaborate with Research and Preclinical Development scientists on regulatory submissions, 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 assigned clinical trial activities are conducted in accordance with Good Clinical Practice (GCP) and applicable regulatory requirements.
• Develop and maintain relationships with key oncology investigators to strengthen the scientific quality of clinical study design, execution, reporting, and publication.
• Participate in trial‑related advisory boards, investigator meetings, and lead protocol training sessions.
• Support other Clinical Development and organizational priorities as needed.
• Contribute to a culture that reflects ALX Oncology's values by acting with integrity, accountability, transparency, and respect. Build strong, collaborative relationships through active engagement with colleagues, including regular onsite participation consistent with the company's hybrid work model.

Preferred Qualifications include:

• PhD or MD with a minimum of 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 responding to patient eligibility questions, reviewing 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, with the ability to apply this knowledge to clinical trial design, clinical trial 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 the clinical development of biologic and/or small‑molecule therapies.
• Strong working knowledge of FDA and EMA regulatory requirements and expectations, Good Clinical Practice (GCP), International Council for Harmonisation (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; experience with Spotfire, interactive voice response systems (IVRS), and electronic data capture (EDC) systems.
• Ability to travel domestically and internationally up to 25% of the time, as required.

Compensation

The salary range for this position at our South San Francisco, CA corporate office is $305,000-$325,000. Actual salary will be determined based on relevant experience, academic credentials, and specialized clinical and medical expertise. In addition to a competitive market‑based salary, ALX Oncology offers the opportunity to participate in stock programs, a performance‑based bonus, and a comprehensive benefits package including 401K. Additional information can be found here: https://alxoncology.com/careers/

About ALX Oncology

ALX Oncology (Nasdaq: ALXO) is a clinical‑stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno‑oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR‑targeted antibody‑drug conjugate with a differentiated mechanism of action. A Phase 1, dose‑escalation trial of ALX2004 is ongoing in patients with EGFR‑expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ ALX Oncology.

ALX Oncology is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, sex, national origin, citizenship, immigration status, sexual orientation, age, marital status, veteran status, or disability status or any other protected status.