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Sr. Director, Early Clinical Development - 000008

Company:
OUTSOURCE Consulting Services, Inc. (OCSI.co)
Location:
San Francisco, California, United States
Posted:
December 01, 2016

Posted By Premium Recruiter

Description:

Seeking a Senior Director, Early Clinical Development to join a leading pharmaceutical company in San Francisco, CA.

Requirements:

Provide leadership for one or more early Clinical Development Teams (eCDT) in the Infectious Disease Therapeutic Area from NME declaration through Phase 2a

Oversee and contribute to the development of a pre-clinical and subsequent clinical development plan and areas of responsibility in (but not limited to) planning and executing of:

Pre-clinical plans to support the initiation of clinical trials in humans

Clinical programs conducted within timelines and budgets while ensuring regulatory compliance;

CMC strategy to support CDP

Regulatory strategy to support CDP.

Additional Responsibilities:

Contribute to the development of budgets and resource forecasts for all relevant pre-clinical and clinical development activities

Matrix management of the eCDT in their area of responsibility to ensure high quality execution of CDP including adherence to timelines and budgets

Interact with other groups outside of the eCDT to ensure input into CDP where appropriate

Interact with other groups outside of the eCDT to ensure that appropriate resources are available to enable the CDP and that other departments are aligned with the CDP

Participate in strategic planning activities coordinated via the Disease Area Strategy (DAS) group

Ensure that project key project milestones/strategy are communicated to the wider teams and endorsed by senior management.

Ensure clinical development programs are tracked and communicated in a consistent and effective manner

Interact with the TA’s Senior Leadership Team to ensure that the eCDT’s plans are aligned with department goals and within anticipated budgets

Ensure smooth transition of compound(s) from early development into late development

Qualifications:

Must have at least 8 years’ experience in a relevant therapeutic area, with strong knowledge in Infectious Diseases is required.

Experience in early phase clinical drug development is required, regulatory interactions is preferred

Demonstrated ability to work effectively with highly functional teams is required.

Experience developing antiviral compounds in an early development setting is strongly preferred

Self-motivated and able to work independently with minimal supervision is required

Minimum of a Master’s Degree is required. An advanced degree (PhD or MD) strongly preferred.

Additional Information:

OCSI.co is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, arrest and conviction records, or any other characteristic protected by law. OCSI.co is a participant in the U.S. Federal E-Verify program. Women, minorities, disabled and veterans are encouraged to apply.

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