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Senior Director, Clinical Operations

Details
Posted By:
Kate Higgins
Posting ID:
3714m2219
Location:
Mountain View, Ca
Telephone:
Tags:
 clinical 
Category:Biotech / Science
Listing Type:Job
Employment:Full Time
Company:VIVUS, Inc.

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VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. Analysts speculate that the potential market for obesity ranges from $5 billion to $10 billion annually, and the indications targeted by VIVUS' sexual health products each represent a projected market greater than $1 billion annually. We currently have an opening for a Senior Director of Clinical Operations in our corporate headquarters in Mountain View, CA.

The Senior Director of Clinical Operations will work with Program Leads and Program Operations Managers. This individual is head of clinical operational activities for VIVUS. You will supervise operations staff and all activities related to execution of clinical studies and programs in accordance with company SOPs, FDA, & ICH guidelines and regulations. You are also accountable for the successful execution of, and timelines for, all VIVUS clinical trials and programs. You must possess a high level of expertise with clinical and regulatory requirements both locally and internationally regarding clinical operational processes and requirements, and can effectively apply this knowledge to guide operational staff to achieve corporate objectives.

RESPONSIBILITIES:
. Oversee operational execution of clinical protocols.
. Supervise all internal and external staff associated within clinical
operations as well as CROs and vendors.
. Oversee strategy and successful data collection, assessment, analysis,
and associated discrepancy resolutions. This may include team
meetings/presentations with Sr. Management as needed.
. Define and present complex operational objectives as required for Sr.
Management.
. Manage processes linked to successful financial objectives for budgets,
contracts, and payments. This role will have dotted line
responsibilities to the VP, Chief Comptroller for VIVUS.
. Oversee data collection activities for all clinical programs: CRF, SAE
assessment, queries, and follow-up, annual reports, investigator
brochures, NDA etc.
. Oversee management, professional development, training, and performance
of all operations staff.

REQUIREMENTS:
. MS, PhD, or equivalent and 10+ years clinical operations experience in
a CRO and/or industry, and strong background in successful execution of
large clinical programs.
. Proven history in drug R&D success evidenced in clinical trial and
regulatory success milestones (NDA, EOP2, etc).
. Experience in several therapeutic areas is a plus.
. Experience in large-pharma or CRO operations management is a plus.
. Superior interpersonal skills required. Must be able to establish peer
relationships and communicate effectively with company disciplines,
cross-functional, and external teams.
. Proven ability to simultaneously manage activities and personnel
associated with multiple clinical trials and programs with short
timelines.
. Attention to detail and commitment to high quality and on-time
deliverables is required.
. Expert computer skills required.
. Exceptional ability to manage and mentor people
. Ability to travel up to 50 % required.

Please submit your resume, with salary history and salary requirements.

Only candidates meeting this criteria will be considered.


EOE.

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