Director, Clinical Science
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 are aiming high in our fight against cancer. We are a team of highly experiences and driven professionals who are committed to excellence in all that we do. Our leadership team has successfully developed new drugs before. We know that 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 located in Brisbane, CA.
Reports To: CMO
Job Description and Responsibilities:
Supports Medical Director and CMO with development of clinical strategy and the design, conduct and reporting of clinical trials,
Reviews and/or writes clinical science documents and/or provides clinical science input into documents such as protocols, safety monitoring plans, process documents, investigator brochures, etc.
Collaborates with Medical Director, clinical operations, data management and other groups to conduct clinical review of study data; identifies and evaluates study data trends, protocol violations, etc.
Analyses data and generates slides for management reporting, Board of Director and Advisory Board Meetings and responds to management requests and queries.
Represents Clinical Development [CD] on various sub-teams or other appropriate forums
As appropriate interacts with cooperative groups, key opinion leaders (KOLs), external vendors etc.
As appropriate and alongside the Medical Director/ CMO, may also participate in external interactions with health authorities (HAs).
Clinical Development Planning and Strategy
- Maintains scientific and clinical knowledge in the specific disease area.
- As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
- Participates, alongside Medical Director and CMO in the development of clinical strategic plans,
- Reviews and/or writes all clinical science documentation including but not limited to protocols, safety monitoring plans, process documents, investigator brochures, ICF, SAP, CRF etc.
- Helps coordinate the successful completion of documents with other groups
- As needed/ appropriate, collaborates with others in the review of safety narratives and other safety related guidelines and documentation.
- Collaborate with clinical operations to develop and implement the overall data quality plan.
- Develops and provides input for clinical presentations slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with Medical Director (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc).
- Collaborates with clinical operations to develop materials for investigator and other relevant meetings.
- As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings.
- Provides additional support with site training, as needed, or requested.
- Responds to questions from other internal and external parties regarding assigned studies and programs
- Works closely with Medical Director, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting.
- Collaborates with Medical Director, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc.
- Participates in safety meetings and tracks, analyzes and reports any potential safety events.
- Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments.
- Assists Medical Director/ CMO in responding to HA inquiries.
- Supports Medical Director/ CMO in preparing for internal and external meetings and presentations.
- Generates slides for management reporting, Board of Director and Advisory Board Meetings.
- Responds to management requests and queries.
Position Requirements and Experience:
PhD in relevant discipline or Pharm D
2 + years' experience in biotech or pharmaceutical as a Clinical Scientist for oncology clinical trials. At least 10 years' experience and evidence of mature leadership skills in a fast-paced Biotech environment is required for appointment at a senior level
Experience working with Translational Medicine
Experience interacting with FDA and other HA
Able to develop and maintain relationships with stakeholders from internal and external functions to ensure intended goals are accomplished in timely manner.
Self-motivated and able to work with limited supervision
Benefits: 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.