ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.


The Clinical Scientist will be a critical member of a multi-disciplinary team supporting the overall clinical development of evorpacept. In this role, the candidate will participate in the creation of clinical development and regulatory strategy; analyze, summarize and present clinical study data; draft relevant sections of study protocols and key regulatory documents; effectively engage internal and external study teams. This is an exceptional and unique opportunity to gain experience in clinical development in close collaboration with the clinical lead at a successful and fast-paced clinical-stage biopharmaceutical company.


Responsibilities include, but are not limited to:

· Clinical Trial Oversight: review and provide content for ICFs, protocol amendments, and regulatory documents; assist with data cleaning to support outputs for regulatory documents, external data presentations, and database lock activities; author and review CRFs; provide CRO oversight, in conjunction with clinical operations, for assigned clinical studies; support site protocol training; ensure trial conduct in accordance with GCP and applicable regulatory requirements.


· Clinical Strategy: provide input on major clinical trial milestones and timelines; assist with authoring of clinical sections for regulatory documents (e.g., Investigators’ Brochures, IND/BLA submissions, responses to Health Authority queries); provide strategic direction for data listings, SAP, and DM plan; assist with clinical indication and protocol planning; participate in Health Authority meetings as requested; partner with clinical lead to maintain study alignment with company objectives; participate in drafting of scientific publications.


· Data Analysis: collaborate with study clinician, pharmacology, biostatistics, translational, and operations to ensure appropriate and accurate study data collection; analyze, review and summarize clinical safety and efficacy data from ongoing clinical studies; collaborate with research, preclinical development and translational scientists to support and analyze pharmacodynamic study data.


 · External Collaboration: partner with clinical lead to develop working relationships with study investigators and key opinion leaders; conduct external calls, meetings, and study related advisory boards to advise on clinical development strategy and protocol design.



Requirements

· Minimum of Doctorate degree, PharmD, or equivalent with postgraduate training in oncology or related specialty with 5 years of relevant experience in clinical trial conduct, clinical data collection, analysis, and interpretation.

· Proven track record of scientific publications.

· Experience with FDA regulations and expectations, GCP, ICH guidelines, and clinical drug development. 

· Strong verbal and written communication skills and collaborative attitude.

· Highly motivated and able to work both independently and collaboratively in a fast-paced environment with a desire to learn and tackle new challenges.

· Domestic and/or international travel may be required.

· Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home). 


 

Salary: 

Clinical Scientist: $160,000-$190,000 DOE

Senior Clinical Scientist: $200,000-$240,000 DOE



ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.


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