Medical Director, Clinical Development
Clinical | Brisbane, CA | Full Time
At Arch Oncology, we are aiming high to discover and develop new antibody therapeutics to treat patients living with cancer. Our best-in-class anti-CD47 antibody, AO-176, is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class. AO-176 works by blocking the “don’t eat me” signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 also directly kill tumor cells. Importantly, it preferentially binds to tumor cells, instead of to normal cells, and binds more potently to tumors in their acidic microenvironment (low pH), offering a potential safety advantage. AO-176 is currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. Behind AO-176, our research team is developing a pipeline of antibodies with best-in-class profiles for the treatment of patients with cancer.
We aim high in the fight against cancer. As a team of highly experienced and driven professionals, we are committed to excellence in all that we do. If you share this commitment and want to work with a team focused on improving the lives of caner patients, aim high with us and apply.
At Arch Oncology, we have two locations. Our headquarters is in Brisbane, CA, a gateway of biotechnology innovation, and our scientific research laboratory is in St. Louis, MO, home of the Gateway Arch. This position is in Brisbane, CA.
Job Description and Responsibilities:
- Design protocols and clinical studies to meet the agreed strategic contexts
- Lead study teams in writing synopses and background sections of the protocols, review and approve study processes, ICFs, and deliverables
- Participate in development of regulatory and study documents, CRFs, statistical analysis plans (SAPs), SRC charters and other documents as required
- Finalize protocols and amendments
- Responsible for study conduct in conjunction with clinical operations
- Actively interact with investigative sites, Site Department Review, IRB, etc. by responding to protocol/medical/safety questions, reviewing the literature as needed
- Participate in Clinical Sub Team, Development Team and Project Team meetings, as required
- Assist with subject evaluation and protocol adherence
- Review and approve enrollment packets
- Review safety reports to support regulatory notifications and filings
- Participate in vendor selection for CRO and other outsourcing vendors
- Study Level Data Review
- Review all patients narratives and patient data generated by data listings or statistical analyses
- Review individual data with SAEs and potentially clinically important laboratory tests or vital sign abnormalities
- Review protocol deviation reports and participate in all reviews and procedures required for database lock
- Request additional tables or analyses where appropriate
- Provide Study team with medical expertise during key activities
- Oversee and conduct protocol training; produce relevant materials
- Develop and deliver protocol training during Investigator meetings and Site Initiation Visits (SIVs)
- Create medical training materials for SIVs, and the study team
- Participate in safety evaluation and support for the investigational products
- Answer medical/safety protocol questions and resolve issues from sited. CRAs and study team, ensuring answers are consistent across all sites and studies
- Review study and individual subject safety for assigned studies and present findings
- Interact with regulatory agencies and internal auditing groups on a study level, providing a response and updates to inspection observations
- Assists with regulatory activities to support study conduct and future marketing approval strategy and execution
- Produce Clinical Study Reports (CSR), approving patient narratives
- Contribute to IB updates for the project
- Assist in development of scientific meeting abstracts and presentations as well as manuscripts, including slides for Board of Director/Advisory Board Meetings
- Perform other duties as required
Position Requirements and Experience:
M.D. degree or equivalent with 2+ year's experience in Oncology clinical trials and drug development.
Prior clinical research experience in biotech or pharmaceutical company; preferably in a small company
Demonstrated experience conducting clinical studies supporting early stage cancer research
Experience interacting with Translational Medicine
Experience interacting with FDA, other regulatory agencies
Arch Oncology offers a generous benefits package including medical, dental, vision, and disability insurance, as well as paid time off and a 401k plan.
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.