JOB POSTING

Senior Vice President, 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.

We are seeking an exceptionally talented individual to provide clinical expertise to shape and inform the overall development strategy for the company’s growing oncology portfolio. This position reports to the Chief Medical Officer. The candidate will lead a multi-disciplined development team encompassing clinical development, regulatory, safety and pharmacovigilance efforts, providing strategic thinking and medical leadership for the execution of ALX Oncology’s clinical programs in oncology.  They will ensure that activities are prioritized that align with disease area clinical strategy. This position will be located in Burlingame, CA. Domestic and/or International travel may be required up to 20% of work time.

Responsibilities

These may include but are not limited to: 

  • Develop clinical trial strategies for oncology products in clinical development.
  • Design, plan, analyze, report and publish ALX Oncology sponsored clinical trials.
  • Work with cross functional teams to support execution of each assigned study.
  • Develop collaborative relationships with Research, CMC, and Business Development, stakeholders.
  • Work with multidisciplinary team to support data cleaning and database lock activities.
  • Work with multidisciplinary teams to ensure quality oversight of the study (quality, regulatory, and safety).
  • Lead the development of 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.
  • Oversee trial-related advisory boards, investigator meetings.
  • Work with CRO data management and clinical sub-team on data integrity and analyses for study and planned/actual filing activities as required.
  • Serve as the external clinical “face” of the program in interactions with investigators, development partners, and 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.
  • Hire and supervise employees, both directly and indirectly.
  • Oversee performance management and career development for direct reports.

Education, Experience, and Skills

  • MD or MD PhD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty.
  • Minimum of 10 years clinical research experience in oncology clinical development within a biotechnology and/or pharmaceutical company.
  • Demonstrated leadership overseeing development programs with multiple assets across solid and hematologic indications.
  • Expertise in the design, execution, and reporting of late stage clinical trials in oncology with small and/or large molecule drug candidates.
  • 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.
  • 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.

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