Vice President – Clinical Operations
OncoCyte is focused on developing liquid biopsy molecular diagnostics to address unmet needs in the diagnosis and treatment of cancer. The VP, Clinical Operations is the most senior person responsible for the clinical operations function at OncoCyte across all programs.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
- Oversee the Clinical Operations functions and all activities related to execution of clinical studies and programs in accordance with company SOPs, FDA, & ICH guidelines and regulations.
- Direct the successful execution of all clinical trials, programs, timelines and clinical milestones.
- Demonstrate a high level of expertise with clinical and regulatory requirements regarding clinical operational processes and requirements, and effectively apply this knowledge to lead the clinical operations department to achieve corporate objectives
- Provide direction for all clinical operations and external department staff and resources associated within clinical operations, CRO’s and vendors, supply chain, clinical quality and regulatory operations.
- Oversee management, professional development, training and performance of all clinical operations staff.
- Program team leader for interdisciplinary project teams to ensure the successful execution of clinical programs and clinical operation.
- Working closely with the OncoCyte staff to develop strategy necessary for successful data collection, assessment, analysis, and data management
- Resolve clinical operations issues, such as data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, and timely review of trial master files, etc.
- Manage all budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in an effective manner.
- Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, PMA, etc.
- MS in a related discipline is required; Ph.D is strongly preferred
EXPERIENCE & SKILLS:
- 10+ years of increasing responsibility in a clinical operations group or CRO in the biotech/diagnostics/pharmaceutical industry, and strong background in successful execution of global clinical programs.
- Ability to direct the implementation of all the Clinical Operations function to ensure compliance, including but not limited to, maintenance of clinical SOPs, documentation of clinical trial and inter-department/vendor communication, oversight of vendors and CROs, auditing of vendors and clinical sites and TMFs.
- Experience in several clinical areas, such as, inflammation, endocrinology, and oncology. Must have experience in managing the execution of complex clinical trials.
- Proven history of product development, demonstrated through comprehensive clinical trial design and execution and prior regulatory accomplishments (LDT’s/NDAs/INDs).
- Strong experience in CRO and vendor management to support clinical trials, including excellent senior leadership, project management, budgeting, and negotiation skills, required.
- Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
- Outstanding verbal, written, presentation and interpersonal communication skills, including a positive and professional attitude, ability to establish peer relationships across company departments and cross-functional and external teams. Experience hiring and leading clinical operations teams to include career development of team members.
- Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment in an executive leadership role. Ability to “roll up your sleeves” and individually contribute to accomplish specific timelines and goals.
- Acceptable computer program skills, such as MS Office Suite and Project management software
The work required for this position is to be performed on-site in a formal office or in a home based office. Position will require travel
Please send your resume to email@example.com if you would like to be part of this growing and dynamic team.