Associate Director, Clinical Operations
San Francisco, CA
Job Number: 2022292
Scope of Responsibilities
The Associate Director (AD) with some supervision oversees a clinical program that includes multiple clinical trials and all operational activities. The position is responsible for timelines, quality delivery, and vendor oversight as well as oversight of clinical team staff. The Associate Director will have experience in managing staff, global operations and Phase III execution to the table.
• Ensure that Department Corporate goals and objectives are met
• Provide operational leadership to the direction, planning, execution and interpretation of clinical programs and data collection
• Develop, implement and manage teams on multiple clinical trials
• Develop and manage study and/or program timelines and resources
• Responsible for direct reports
• Responsible for ensuring SOPs and regulatory compliance of staff and clinical sites
• Responsible for CRO/vendor selection and management.
• Responsible for writing or reviewing protocols, study plans, study reports, and regulatory documents (e.g., IND, NDA, BLA, etc.)
• Responsible for reviewing or developing MOH/IRB/EC responses
• Responsible for the development of SOPs, systems and policies supporting clinical studies as well as providing ongoing program updates to include identifying risks and any mitigation strategies and solutions.
• Interact with investigators, vendors and CROs to ensure quality and timely delivery of program deliverables.
• Bachelor's degree in a relevant scientific discipline or equivalent
• At least 12 years of relevant clinical experience in the pharmaceutical industry or equivalent
• Knowledge of FDA regulations, GCP and ICH guidelines required
• Excellent communication and interpersonal skills and ability to lead teams and motivate team members
• Able to prioritize and handle multiple tasks and to use clear judgment to solve problems
• Proficiency with MS Word, Excel, Outlook, and PowerPoint
• Must be willing to travel as required
FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
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Notice to Recruiters and Search Firms
FibroGen makes every effort to source and hire its staff through direct recruitment methods. Employment opportunities at FibroGen are managed by our internal human resources team. Please do not contact hiring managers or other FibroGen employees.
FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves. FibroGen does not accept unsolicited communications from external recruiters. If there is a specific business need, a human resources team member will contact external recruiters directly.
An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources. Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.
To apply, please visit: https://fibrogen.wd5.myworkdayjobs.com/FibroGen/job/San-Francisco-CA/Associate-Director--Clinical-Operations_2022292
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Preferred Years Of Experience:12 Year(s)
Education Required:4 Year Degree - BS
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