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Senior Director, Clinical Operations

Company: Coherus BioSciences
Location: Redwood City
Posted on: January 7, 2022

Job Description:

Title: Senior Director, Clinical Operations
Reports To: Head of Clinical Operations
Location: Redwood City, California
Classification: - Exempt Overview: This position will work with other Coherus clinical team members to manage clinical operations and execution of clinical studies in support of Coherus programs. This position will manage various clinical operations activities as a key contributor, and directly oversee CROs', and other vendors, including clinical sites; collaborate with clinical development partners, as well as other internal functional areas, for successful clinical trial execution. Primary Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:

  • Develop protocols which can be implemented by the CRO and clinical sites and ensure adherence to all documentation requirements and process.
  • Set and manage well-defined clinical project timelines and milestones with the CRO, Clinical Development and executive team, escalating issues that may jeopardize timelines and deliverables.
  • Act as primary CRO oversight and liaison to CROs and vendors for assigned clinical studies/programs, providing Coherus representation and adherence to project scope, deliverables and timetables.
  • Coordinate and manage activities with Coherus development partners, CRO and clinical sites from study initiation to close out Implement protocols with the CRO and ensure adherence to all documentation requirements and process.
  • Act as a as primary liaison and key collaborator with clinical teams of development partners on assigned studies/programs.
  • Manage study logistics and monitoring activities (or provide oversight) to ensure milestones and deliverables are well defined and achieved.
  • Collaborate with other Coherus functional areas and consultants, such as Clinical Development, Project Management, Supply Chain, Clinical Quality Assurance (CQA), and Regulatory Affairs in order to successfully coordinate assigned clinical studies/programs.
  • Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory (PK/PD) data, data cleaning status for assigned trials/programs, etc.
  • Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, study plans, investigator brochure, clinical study reports, regulatory documents (e.g., INDs, BLAs).
  • Oversee the development, forecasting, monitoring, and reporting of assigned clinical trial budgets.
  • Develop and contribute to finalization of clinical project timelines to meet critical company milestones; recognize and escalate issues that may jeopardize timelines and deliverables, or lead to out of scope expenses.
  • Coordinate RFP process, review vendor proposals, and negotiate clinical budgets for assigned trials/programs.
  • Conduct clinical site, CRO, and/or vendor co-monitoring visits with CRO staff, and/or with CQA personnel, including pre-study qualification visits, vendor qualification visits, routine study visits, trial master file review visits, etc.
  • Monitor the maintenance of the clinical trial master files per Coherus SOPs. Review clinical study files for completeness periodically throughout and at the completion of clinical trials and prior to archiving. -
  • Organize and run assigned clinical study team meetings and teleconferences.
  • Facilitate study start-up with CROs and clinical sites as necessary, including, work with CRO to complete template clinical documents, such as, ICF, source document worksheets, CRF specifications, and CRF documents, clinical site agreement, and other study documentation.
  • Develop or contribute to the writing and implementation of Standard Operating Procedures (SOPs) and standard forms to support clinical operations, and study-specific guidelines.
  • Oversee, as well as collaborate with other Coherus staff to ensure clinical trials are completed in compliance with FDA regulations, ICH guidelines for Good Clinical Practices (GCP) and the conduct of clinical trials.
  • Travel as required to domestic and international development partners, CRO's, vendors, and clinical sites, as needed, approximately 30% - 40%.
  • BA/BS and direct relevant experience in global drug development required, advanced degree (MS/PhD) in a life science major is preferred.
  • 10+ years of experience of biotech/pharmaceutical clinical operations experience, specific to a mix of sponsor trial management experience and clinical CRO experience, i.e., managing CRO activities, contracts and ongoing relationships.
  • Must have experience in managing the execution of complex phase 1-3 global clinical trials, preferably in oncology-related clinical therapeutic areas; P1 experience is a plus.
  • Strong experience in CRO and vendor management to support global clinical trials.
  • Strong knowledge of FDA/EMEA regulations and ICH/GCP guidelines regarding clinical trial management.
  • Demonstrated skills in writing/reviewing clinical study protocols, CRF, and study documentation development, CSR's, regulatory documents (including IND and BLA)
  • Understanding of data management, statistics and medical writing processes for clinical development.
  • Team-oriented with excellent communication and interpersonal skills demonstrated ability in managing indirectly.
  • Ability to "roll up your sleeves" and individually contribute results to clinical operations and company-wide goals.
  • Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects.
  • Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision.
  • Ability to travel domestically and internationally. Some travel will take place on/over weekends.
  • Demonstrated computer skills using MS Office Suite (MS Word, Excel, PowerPoint, and Project) software.
  • Perform other related tasks as requested. Language Skills Ability to write reports, presentations, and business correspondence. Must effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Analytical and Reading Skills Ability to define problems, collect data, establishes facts, and draw valid conclusions. Physical Requirements While performing the duties of this job, the employee may be required to perform lifting tasks of up to 10 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision and color vision. The noise level in the work environment is usually moderate. Safety Coherus is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others. If you had selected 'Other', please provide more details below
    If you had selected 'Referral', please provide more details below

Keywords: Coherus BioSciences, Redwood City , Senior Director, Clinical Operations, Healthcare , Redwood City, California

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