Director/Sr. Director, Translational Medicine
Director/Sr. Director, Translational Medicine
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 are aiming high in our fight against cancer. We are a team of highly experienced and driven professionals who are committed to excellence in all that we do. Our leadership team has successfully developed new drugs before. We know what we need to do to collaborate and execute to get the job done.
If you share this commitment and want to work with a team that is focused on helping patients come aim high with us and apply.
Position Location: At Arch Oncology, we have two bases. 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.
Reports To: VP, Translational Medicine
Job Description and Responsibilities:
· Serve as member of cross-functional team, responsible for executing on translational strategy of AO-176 and potential follow-on programs (e.g. drug mechanism of action, mechanisms of resistance, rational combinations, new indications, patient segmentations, and product differentiation)
· Responsible for the development and delivery of biomarker components of clinical trials, including protocol development, implementation and execution of translational plans and analysis of biomarkers
· Responsible for interfacing with the research team to ensure alignment with clinical path and to assist with communication and translation between research and development organizations
· Responsible for evaluating CROs for assay/technology platforms and data analysis capabilities, creating SOWs and interfacing with CROs for execution of services
· Maintain routine and close partnership with translational operations to ensure integration of scientific and clinical strategy with sample collection, processing, storage and data transfer.
· Build effective cross-functional relationships across organization to achieve goals of the function and the business
· Help map development workplans and coordinate cross-functional activities through direct interaction with clinical research physicians, clinical operations, contract research organizations and internal scientists
· Co-author reports, scientific communication materials, and manuscripts
· Communicate internally and externally including preparing and delivering presentations to senior leadership, colleagues and external audiences
Position Requirements and Experience:
· Ph.D. in life or medical sciences with a minimum of 10 years of experience working in the biotechnology or pharmaceutical industry
· Prior experience (5+ years) focusing on biologics, oncology and immune oncology programs from a translational medicine perspective
· Broad understanding of the drug discovery pipeline, from research through clinical development, having successfully transitioned programs from IND to the clinic
· Candidate must be a rigorous scientist with a track record of facilitating non-clinical research, effective collaboration, influential communication and clear impact on drug development. Must be a motivated, results-oriented self-starter, who enjoys working in a fast-paced, dynamic team environment who is accountable for timelines and deliverables
· Prior experience with clinical trial/informed consent documents and designing PK and biomarker strategies that align with pre-clinical research as well as clinical development aims
· Experience working with clinical and translational operations to design kits, clinical lab manuals and data transfer specifications in order to guarantee integrity of sample collection, handling and analysis
· Prior experience acquiring and analyzing PK and exploratory data from clinical trials and integrating with clinical endpoints to ensure impact on development program
· Familiarity with establishing and analyzing data from immunohistochemical (simple and multiplex), flow-based, multiplex ELISA and gene expression assays (i.e. Nanostring) is desired; experience with data analysis tools and ways to optimize data visualization are required
· Non-clinical pharmacology and toxicology experience a plus
· Proven scientific/leadership expertise (working in teams, managing projects, mentoring junior scientists)
· Strong verbal and written communication skills
· Can multi-task and embraces fast-paced culture, flexible/adaptable and resilient
· Thinks strategically and is motivated by science behind drug development as well drug development challenges
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.