Associate Director, Global Clinical Operations

Location
Emeryville, CA, United States
Posted
Aug 31, 2018
Ref
oQid8fwd
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

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

PRIMARY PURPOSE OF POSITION

As an Associate Director of Global Clinical Operations, the primary responsibility is the is oversight and execution of all Phase 1-4 clinical trials. In partnership with 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.

MAJOR DUTIES OF POSITION:
  • Contributes to the development of global operational strategy and tactics and facilitates strategic and tactical discussions within Global Core Teams and sub-teams for assigned projects.
  • Provides Clinical Operations input to facilitate strategic and tactical planning, as well as, development activities and regulatory filings for assigned projects.
  • Develops and implements policies and procedures to meet milestones, align with regulatory, company and departmental priorities and ensure clinical trial quality.
  • Tactical implementation and accountable for budget, timelines and quality of assigned clinical programs.
  • Directs the overall execution of all clinical operations activities while complying with developed protocols, regulations, GCPs and/or Santen's SOPs.
  • Proposing resources for the execution of assigned clinical programs within the study's overall approved operational plan and budget.
  • Establishing overall budget including investigator's grants.
  • Providing management with regular, timely, consistent, concise and accurate information regarding clinical operations activities and metrics for assigned projects.
  • Supporting the negotiation with outside vendors to secure services and provide efficient management and oversight of external partners, consultants, vendors and budgets to ensure the timely and cost-effective implementation of assigned projects.
  • Ensuring availability of clinical trial material and clinical supplies.
  • Efficient implementation of departmental policies, procedures and technology to optimize clinical operations delivery models (e.g. full/partial outsourcing; in-house, single or multi-vendor resourcing, etc.) appropriate for all stages of clinical development from Proof of Concept to pivotal trials.
  • Development and utilization of tools and processes to ensure appropriate study monitoring and conduct, data collection, and data validation for assigned projects.
  • Responsible for the completion of clinical sections of regulatory documents
  • Oversee and provide significant input into the authorship of quality study protocols in alignment with global strategy, target product profiles and Santen's goals and objectives
  • Accountable for study timelines and quality metrics related to subject safety, data quality and study integrity
  • Collaboratively make key decisions relating to vendors, sites and overall study strategy
  • Support upper management with 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
  • Appropriately escalate critical issues in a study that may impact the strategic business or financial goals of the studies and/or program
  • Utilize strong influencing skills with key stakeholders
  • Support organizational change to achieve the objectives of assigned programs
  • Drive strong team performance, looking for someone who can inspire others and motivate teams
  • Responsible for mentoring and developing team and delivering performance reviews
  • Provide upper management with regular, timely, consistent, concise and accurate information regarding clinical operations activities and metrics for assigned programs
  • Support the company in relations with major customers, suppliers, etc
  • Perform other duties as necessary as assigned by management

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum BS/MS degree in a scientific discipline or RN, BSN degree or equivalent; Candidates with less than 10 years' experience with an advanced degree (e.g. PharmD, PhD, MD, OD or DO) or equivalent may be considered.
  • Ten or more (10+) years of clinical research experience, preferably in ophthalmology.
  • At least 5 years' experience managing Clinical Operations personnel (e.g. CRAs, consultants, etc.) including vendor management.
  • Experience managing clinical operations for multi-country trials a plus.
  • Thorough knowledge of GCPs and working knowledge of Food and Drug Administration and other regulatory requirements.
  • Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team and an international environment.
  • Ability to function, communicate, and collaborate cross-functionally and ability to work with culturally diverse global groups.
  • Demonstrated track record of driving projects/deliverables to completion within established deadlines, budget and allocated resources.
  • Demonstrated ability to set and prioritize goals and objectives; excellent time management, negotiation, problem-solving and organizational skills and the ability to work independently.
  • Demonstrated ability to make appropriate tactical decisions within global and distributed team environments.
  • Strong verbal communication and scientific writing skills, as well as, strong interpersonal/group skills.
  • Proven ability to demonstrate tact and positively influence others in a multi-cultural environment and across all organizational levels.
  • Moderate to high level of understanding of scientific and statistical principles vis-a-vis clinical trial design, operations and analysis/presentation/reporting of data collected in clinical trials.