This job board retrieves part of its jobs from: Pennsylvania Jobs | Montreal QC Jobs | California Jobs

  Jobs in California  

Bringing the best, highest paying job offers near you

previous arrow
next arrow
Slider

VP Global Clinical Physicians & Operations

ExecuNet

This is a Contract position in Emeryville, CA posted November 16, 2020.

ABOUT THE POSITION:

The Vice President, Global Clinical Physicians and Operation will supervise global clinical operation for innovative and established products and supervise innovative and established products from a clinical/medical perspective.

This position will pursue operational excellence for clinical operation unit work. They will also serve as a Clinical trials officer for all the clinical trials conducted at Company.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

  • Contribute expertise in all operational activities pertaining to the execution of clinical trials
  • Inspire the team of professionals in the Clinical Operations organization to design and deliver high quality clinical trials and study reports while expertly navigating global requirements and managing vendors
  • Ensure clinical programs are managed and executed with the highest quality and integrity in site execution
  • CRO oversight, compliance to SOPs, protocols, management plans and budget
  • Grow, develop and mentor the team to improve processes, display leadership, and collaborate to execute the functions of the department as a best-in-class organization
  • Partner with Clinical Development and other stakeholders on creating Clinical Development Plans
  • Develop strategy and drive implementation of Phase 1 to 3 clinical operation plans and timelines, working cooperatively across the company
  • Ensure high quality data collection and data management, with appropriate oversight of vendors providing data management services
  • In collaboration with Clinical Development, Project Management, Finance and other stakeholders, oversee clinical project schedules, timelines, budgets and key performance milestones to meet corporate objectives
  • Direct the selection of clinical CROs and other vendors and lead management of the vendor relationship to maintain cooperative and productive study support
  • Review US, EU and other applicable regulatory guidance on clinical trial operations to ensure compliance to necessary regulations and inspection preparedness in all regions
  • Direct the implementation of clinical standard operating procedures (SOPs) that meet ICH, EMA and FDA requirements
  • Provide oversight to ensure SOPs are followed across all programs, including with CROs, central laboratories, data management and other third-party vendors
  • Oversee and maintain clinical trial master files and other clinical documents to ensure inspection readiness at all times
  • Support the company’s Business Development efforts in the assessment of new product candidates if needed or requested.
  • Effectively and articulately present updates, strategies, plans, and data to company leadership. Other duties as assigned

QUALIFICATIONS:

Core competencies, education, and experience.

  • MD, MD/MBA, MD/PhD required
  • Position will be filled at level commensurate with experience, with a minimum of 10+ years of pharmaceutical industry experience in clinical development functions across Phase I through IV required.
  • Ophthalmology experience is strongly preferred
  • Experience in the successful development of rare disease therapeutics is preferred, but not required. Regenerative Medicine (Gene & Cell therapy) knowledge/familiarity would also be additive. More important than specific therapeutic expertise is the ability to be creative and strategic around developing processes that may be without precedent
  • Sound scientific and clinical judgment
  • A strong business sense; able to link the scientific and business needs
  • Ability to travel
  • Excellent communication skills, self-motivated, innovative, with highest level of professional ethics, accountability and integrity
  • Experience leading and collaborating cross-functionally with R&D and non-R&D key partner groups, thereby helping to shape the future of the entire Company organization
  • Experience with clinical study design, health economics or medical statistics
  • Team oriented with the confidence, maturity and integrity to work effectively with Company senior leaders, key opinion leaders and health care professionals
  • Able to demonstrate a high level of strategic thinking and business acumen within a strong and well educated group in order to effectively manage internal and external relationships and gain credibility in the role

Please add your adsense or publicity code here (inc/structure/adsfooter.php)