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Vice President, Clinical Operations

Redwood City, CA

Vice Title:                            Vice President, Clinical Operations
Reports To:                         Chief Medical Officer
Location:                              Redwood City, California
Classification:                    Exempt
 
Overview:

The Vice President, Clinical Operations is the most senior person responsible for the clinical operations function at Coherus across all programs. 

Responsibilities:

  • Oversee management, professional development, training and performance of all clinical operations staff.
  • 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, budgets, 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, drug supply chain, clinical quality and regulatory operations.
  • Program team leader for interdisciplinary project teams to ensure the successful execution of clinical programs and clinical operation.
  • Working closely with the Chief Medical Officer, SVP biostatistics, and SVP of Regulatory to develop the strategy necessary for successful data collection, assessment, analysis, and data management with the CRO.
  • 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, BLA, etc. 

Experience and Education:

  • BS/MS/PhD in related field is preferred.
  • 15+ years of increasing responsibility in a clinical operations group in a CRO and the biotech/pharmaceutical industry, and strong background in successful execution of large global clinical programs.
  • Experience hiring, leading clinical operations teams and overseeing their career growth skills.
  • 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 therapeutic areas, such as, immune-oncology, oncology-hematology, inflammation, and ophthalmology. Must have experience in managing the execution of complex phase 3 global clinical trials.
  • Proven history of strategic drug development, demonstrated through comprehensive clinical trial design and execution and prior regulatory accomplishments (NDAs/INDs).
  • Strong experience in CRO and vendor management to support global 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.
  • Experience managing regulatory inspections
  • 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.
  • English as primary language or excellent command of English. Secondary languages considered a plus, but not required.
  • 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, electronic trial master files.

The Base Salary Range for this position is $300,000 to $340,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.


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