This Job listing For Year 2022 is about Meet in South San Francisco, CA
About the job
We have partnered with an exciting, growing, clinical-stage biotech developing novel immunology therapeutics that is seeking a Director, Clinical Operations to join the team. This candidate will report in to the SVP, Clinical Operations and will be responsible for leading their pivotal Global Phase III program.
The Director will be responsible for directing the planning, execution and oversight of the company’s assets in all phases of clinical development programs. The Director provides leadership and oversight of clinical operations staff and clinical trial vendors to deliver clinical development programs within timelines, budget, and with the highest quality.
- Defines the clinical operational strategy of development programs and directs the planning and execution of clinical trials from early development to market filings.
- Accountable for clinical program/study timelines, budgets and manage actual spends to approved budget.
- Contributes to the product life cycle management team (Project Team) which may include review of regulatory or company development documents, regulatory strategy, clinical program design, publication planning, etc.
- Contributes to the strategy and development of documents for interactions with regulatory authorities.
- Oversees qualityisk management of clinical development programs.
- Oversees full service CRO and vendor management activities including request for proposal, vendor selection, development of scope of work, performance management and vendor governance.
- Develops company SOP, work instructions and training for clinical operation activities.
- Ensures clinical programs are implemented in adherence to SOP, GCP, ICH guidelines and FDA regulations.
- BS or advanced degree in life sciences or health-related field.
- 10+ years progressive clinical operations experience within pharmaceutical or biotechnology industry.
- 5+ years of people management and leadership experience.
- Flexible self-starter to operate in a fast-pace start-up environment. Ability to develop out of the box solutions with limited infrastructure.
- Ability to work independently as well as collaboratively in a cross-functional team environment.
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, Project).
- Strong interpersonal skills with excellent oral and written communication.
- Innovative, analytical, and extremely organized to drive projects to completion.
Please contact Marina Menchero on 415-530-2507 or email [email protected] if you would like to know more about this opportunity.
This will be 100% confidential.
Find out more about Meet at www.peoplewithchemistry.com
Vacancy Type: Full-time · Mid-Senior level
Job Location: South San Francisco, CA
Application Deadline: N/A
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