Vice President, Clinical Operations

California
4415
Our client is a research-based biopharmaceutical company. They have asked us to assist them in their search for a Vice President, Clinical Operations.

Major tasks and responsibilities will include:
  • Provides leadership, therapeutic knowledge and supervision for the successful management of international clinical trials across various indications through clinical study teams and through the use of CROs or internal resources.
  • Manages, such as employee new hire; retention activities; performance/rewards management; and succession planning.
  • Delivers strategic guidance to and functional management of Clinical Operations.
  • Manages subordinate directors and/or people managers.
  • Leads and partners in the development and presentation of clinical operational strategy to executive leadership.
  • Financially oversees department, managing spend as planned and ensuring appropriate communication with clinical and corporate finance departments.
  • Supports development of SOPs within department and participates in the development of collaborative SOP development.
  • Oversees and contributes to project team governance documents.
  • Oversees and contributes to Clinical Study Reports.
  • Functions as executive sponsor for preferred vendor relationships.
  • Collaborates cross‐functionally on due‐diligence efforts and assessments for mergers and acquisitions.
  • Collaborates with regulatory, medical affairs and commercial to assist with life cycle management of approved drug products.
  • Oversees and contributes to the development of abstracts, presentations and manuscripts.
  • Initiates and oversees continuous endeavors in assessing and identifying best practices among study teams and implementing standardization among teams.
  • Supports company Public Relations and external corporate giving.

We seek candidates with the following qualifications:
  • Requires the ability to able solve complex problems and use highly developed independent judgement relating to national and international regulations, guidelines, investigator interactions, and timelines.
  • Must have a Bachelor's degree in a relevant scientific area, or a Master's Degree in a non-scientific area, or a BSRN or BS + RN with increasingly responsible clinical operations leadership.
  • Demonstrated excellence in complex project management and the effective management of multiple projects/priorities is required.
  • Must have proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external.
  • Ability to initiate and lead departmental or interdepartmental strategic initiatives is required.
  • Must have proven ability to think critically and creatively, and to be able to work independently to determine appropriate resources for resolution of complex.
  • Requires the ability to effectively communicate with reasonable accommodation.
  • Ability to effectively use interpersonal skills, a capacity to lead multifunctional teams, and to manage staff and mentor and develop junior staff is required.
  • Requires demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
  • Must have the ability to influence across a matrix and create a clear sense of direction.
  • Previous involvement in the oversight and management of regulatory inspections in partnership with Regulatory Compliance is required.
  • Requires inflammation therapeutic area experience.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.
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