Job Description

Clinical Scientist Consultant

ALX Oncology is a 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.

The individual will provide clinical expertise to support the overall development strategy for ALX148. 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.

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 function teams.
  • Plan, analyze, report and publish ALX Oncology sponsored clinical trials.
  • Work with clinical sub-team, and CRO to support execution of each assigned study.
  • Work with clinical sub-team, and CRO to provide integrated pharmacovigilance for the study.
  • Work with multidisciplinary team to support data cleaning and database lock activities.
  • Work with multidisciplinary teams to provide quality oversight of the study (quality, regulatory, and safety).
  • Lead the development of key clinical sections for regulatory submissions.
  • 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 the development of clinical sections of regulatory documents, e.g., Investigators’ Brochures, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
  • Contribute to trial-related advisory boards, lead investigator meetings, lead protocol training meetings.
  • Work with CRO data management and clinical sub-team on data integrity and analyses for the study and planned/actual filing activities as required.
  • Serve as the external clinical “face” of the program in interactions with investigators, development partners, and in leading advisory boards as needed.
  • Collaborate with research and preclinical development scientists to support regulatory submissions, e.g., Breakthrough/Fast Track Designation, pre-IND and IND submissions for new drug candidates.

Requirements

  • Minimum of an MD or PhD degree with at least 5 years clinical research experience in oncology clinical development within a biotechnology and/or pharmaceutical company.
  • Prior 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, Outlook, Power Point, Word, Excel, and with accessing and working with IVRS and electronic data capture systems.

This job will be a remote work-from-home position requiring up to 40 hours per week. Domestic and/or International travel may be required up to 20% of work time. Hourly rate will be based on candidate’s level of experience.

ALX Oncology is an equal opportunity employer. To apply for this position, please send your cover letter and resume to

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