Senior Director, Clinical Operations
Company: Coherus BioSciences
Location: Redwood City
Posted on: January 7, 2022
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
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
- 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
- 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
- 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
- Track and report clinical trial information and progress
regarding patient recruitment, screening, monitoring, clinical and
laboratory (PK/PD) data, data cleaning status for assigned
- 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
- 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
- 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
- Demonstrated ability to meet short-term deadlines and
multi-task in a very fast-paced work environment with little direct
- 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
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Keywords: Coherus BioSciences, Redwood City , Senior Director, Clinical Operations, Healthcare , Redwood City, California
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