VP, Global Clinical Physicians and Operations

Location
Emeryville, CA, United States
Posted
Sep 05, 2020
Ref
ojQqdfww
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
COMPANY DESCRIPTION

At Santen, we are innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field-through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

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 Santen.

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 Santen organization
  • Experience with clinical study design, health economics or medical statistics
  • Team oriented with the confidence, maturity and integrity to work effectively with Santen 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

For more information about our company and the work experience, please visit www.santenusa.com.