Director, Global Clinical Operations

Location
Emeryville, CA, United States
Posted
Apr 01, 2021
Ref
1066
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

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

ABOUT THE POSITION:

As a Director the primary responsibility is oversight and execution of all Phase 1-4 clinical trials. In partnership with other Global Clinical Leaders, Clinical Development operations functions, and relevant other functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registrations and commercialization of Santen’s products.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Develop and oversee clinical studies and/or program(s), planning collaboratively with cross functional team members to ensure alignment with target product profile and regulatory strategies
  • Oversee and provide significant input into the authorship of quality study protocols and other study documents in alignment with global strategy, target product profiles and Santen’s goals and objectives
  • Accountable for study timelines, budgets, key performance indicators and quality metrics related to subject safety, data quality and study integrity
  • Collaboratively make key decisions relating to vendors, sites and overall study strategy
  • Drive the negotiation with vendors to secure services not available internally
  • Oversee external partners, consultants, vendors and budgets to ensure timely and cost-effective implementation of services for assigned studies or programs
  • Serves as decision and escalation point for resolving critical issues in a study that may impact the strategic business or financial goals of the studies and/or programs
  • Utilize strong influencing skills with key stakeholders Support organizational change to achieve the objectives of assigned programs
  • Responsible for mentoring and developing direct reports and delivering performance reviews
  • Inspire and motivate team and drive strong team performance
  • Provide senior management with regular, timely, consistent, concise and accurate information regarding clinical operations activities and metrics for assigned studies or programs
  • Represents the company in relations with major customers, suppliers, etc.
  • Support senior management in the evaluation and implementation of infrastructure, policies/procedures and technologies to optimize clinical operations delivery models appropriate for all stages of clinical development from proof of concept to pivotal studies Perform other duties as necessary as assigned by management

QUALIFICATIONS:
  • 15 or more (15+) years’ experience in of clinical research experience preferably in ophthalmology
  • BS/MS degree or equivalent experience in a scientific discipline
  • Eight or more years managing clinical trials in a pharmaceutical setting with 2-3 of those years in ophthalmic research and development highly preferred
  • Demonstrated ability to manage international clinical studies with designated program budgets and timelines as required
  • Demonstrated excellence in complex project management and effectively manage multiple projects/priorities as required
  • Ability to use influencing skills to change the thinking of or gain acceptance of others in sensitive situations
  • Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems
  • Contributed to clinical study reports, INDs, NDAs and other clinical/regulatory/safety documents
  • Exceptional written, communication, interpersonal, writing and editing skills
  • Solid understanding of clinical development processes and familiar with different strategies and tactics to accelerate projects globally
  • Proven direct management experience
  • Proven ability to manage through teamwork and collaboration
  • Proven ability to positively influence and motivate others and provide direct feedback to direct reports and mentor junior staff is required
  • Ability to initiate and lead departmental or interdepartmental initiatives
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials as required
  • Basic working knowledge of statistics as it applies to clinical analyses of trials