JOB POSTING

Director / Senior Director, Oncology Clinical Development

ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents.

The individual will provide clinical expertise and leadership to shape and inform the overall development strategy for the company’s growing oncology portfolio. The candidate will work within a multi-disciplined development team and will be responsible for the development of ALX Oncology’s clinical trials in one or more tumor histologies. This position reports in to the VP of Clinical Development and will be located in Burlingame, CA, although consideration will be given to exceptional candidates based elsewhere on the West Coast. Domestic and/or International travel may be required up to 20% of work time.

Responsibilities

These may include but are not limited to: 

  • Provide medical monitoring for Phase 1, 2 or 3 studies in collaboration with CRO medical monitors.
  • Author clinical protocols, amendments, eCRF development and related documents.
  • Collaboratively assist clinical operations in developing project timelines in coordination with other functional teams.
  • Plan, analyze, report and publish ALX Oncology sponsored clinical trials.
  • Work with clinical sub-team and CRO to support execution, data cleaning, and database lock activities of each assigned study.
  • Work with clinical sub-team and CRO to provide integrated pharmacovigilance and quality oversight of the study (quality, regulatory, and safety) for the study.
  • Work with CRO data management and clinical sub-team on data integrity and analyses for the study and planned/actual filing activities as required.
  • Lead the development of key clinical sections for regulatory submissions, and contribute to the development of clinical sections of regulatory documents, e.g., Investigators’ Brochures, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
  • Represent ALX Oncology in regulatory interactions (live or virtual).
  • Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trial(s).
  • Develop working relationships with key investigators in oncology area to maximize scientific quality in clinical study design, execution, reporting, and publication.
  • Contribute to trial-related advisory boards and interactions with development partners; lead investigator meetings and protocol training meetings.
  • Collaborate with research and preclinical development scientists to support regulatory submissions, e.g., Orphan Drug/Breakthrough/Fast Track Designation.

Requirements

  • Minimum of an MD degree with at least 5 years clinical research experience in oncology clinical development within a biotechnology and/or pharmaceutical company.
  • Board certification or board-eligibility in hematology or medical oncology preferred.
  • Prior clinical development experience with biological or small molecule therapies.
  • Broad understanding of oncology, internal medicine and clinical pharmacology.
  • Excellent working knowledge of FDA and EMA regulations and expectations, GCPs, ICH guidelines, and clinical drug development.
  • Intimate knowledge of day-to-day medical monitoring of clinical trials required, e.g., responding to questions about patient eligibility, review of safety parameters, receiving and processing SAEs and IND expedited safety reports.
  • Strong communication and collaboration skills.
  • Comfortable with Windows, Gmail/Outlook, Power Point, Word, Excel, and with accessing and working with IVRS and electronic data capture systems.

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.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com