Vice President Clinical Development
Arch Oncology is an immuno-oncology company developing anti-CD47 antibodies for the treatment of cancer. Anti-CD47 therapies represent a new class of checkpoint inhibitors that bridge the innate and adaptive immune systems to attack cancer. Arch Oncology has developed a functionally diverse antibody platform and is advancing a novel anti-CD47 antibody to the clinic that not only acts as an immune checkpoint inhibitor, but also selectively kills tumor cells (non ADCC). The team is a highly motivated group of experienced scientists and emphasizes a collaborative approach. Arch Oncology is funded by top-quality venture capital investors and is advancing its lead mAb to the clinic currently.
Arch Oncology has offices in the San Francisco Bay Area, CA. Our research labs are in the Cortex Innovation Community in St. Louis, MO, near the Washington University School of Medicine and St. Louis University. This position is located in Brisbane, CA.
President and CEO
Job Description and Responsibilities:
Lead the development of clinical programs and provide oversight for clinical trial planning and execution:
- Work closely with key stakeholders to plan and implement clinical development strategies
- Responsible for developing and driving clinical development plans, clinical trial protocols, clinical pharmacology, data analyses, clinical study reports, and other related clinical documents
- Design clinical trials in line with strategic objectives; ability to anticipate and address future commercial and clinical development needs
- Partner with internal and external experts and consultants to refine the clinical development plan and to optimize the scientific integrity of the methodology and ensure that the overall scientific and medical content of all clinical programs is sound
- Work with opinion leaders and expert consultants to keep development plans attuned to recent advances in clinical, scientific, regulatory and competitive environments
- Lead and motivate the clinical science and operations team to effectively and efficiently operationalize the clinical development strategy (i.e. clinical trials management)
- Work closely with Program Management team to integrate resources, to align operational efforts
- Work closely with translational development lead to support exploratory biomarker strategy
- Serve as Medical Oversight for the program
- Provide oversight on quality and compliance for all clinical trial(s) programs
- Manage and contribute to the development of Clinical Study Reports, reporting of clinical trial results and internal/external publications
Position Requirements and Experience:
- MD, MD/PhD or equivalent with extensive clinical experience
- At least 10 years of oncology clinical development experience within the Biotech or Pharmaceutical industry, with focus in Oncology; mAb experience required
- Preferred clinical development background in Immuno-Oncology
- Possess good Oncology early clinical trial development experience
- Understanding of related disciplines (e.g. biostatistics, regulatory, translational development, preclinical pharmacology, pharmaceutical sciences)
- Experience in functioning effectively as a member of a matrix/multidisciplinary team.
- Demonstrated effectiveness in people management, communication and colleague development
- Exceptional verbal and written communication and presentation skills
Arch Oncology is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.