Senior Director, Clinical Operations
- Employer
- Santen, Inc.
- Location
- Emeryville, CA, United States
- Start date
- Sep 5, 2020
View more
- Discipline
- Clinical, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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:
Reporting to the Head of Global Clinical Physicians and Operations and in conjunction with regional Clinical Operation Leaders, this person will direct the US Clinical Operations function to ensure that the operational imperatives of the clinical strategies and trial designs are aligned to ensure efficient and effective use of company resources and are optimized to support the development of innovative and differentiated products for the global ophthalmic market.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
- Accountable for the development of global operational strategy and tactics regarding the design and implementation of global clinical programs to facilitate strategic discussions within global Core Teams and sub-teams
- Accountable for providing Clinical Operations input to meetings and materials to facilitate strategic and tactical planning and development activities and regulatory filings
- Accountable for setting priorities and implementation of functional assignments, policies and procedures to ensure quality, meet milestones and align with company and department priorities
- Ensures that upper management receives regular, timely, consistent and accurate information regarding clinical operations activities and metrics
- Accountable for US budget and resource planning, allocation and management to ensure alignment with approved project targets and milestones of the portfolio under development
- Responsible for ensuring that clinical trial operations are coordinated with other functional groups to ensure subject safety, data quality/robustness/integrity and alignment with target product profiles, legal requirements and regulatory strategies
- Responsible for evaluation and implementation of infrastructure, policies / procedures and technologies to optimize clinical operations delivery models (e.g. full/partial outsourcing; in-house, single or multi-vendor resourcing, EDC implementation, risk based monitoring, etc.) appropriate for all stages of clinical development from Proof of Concept to pivotal trials
- Provide direction and is accountable for the management and oversight of external partners, consultants, vendors and budgets to ensure the timely and cost-effective implementation of clinical development plans
- Represents the company in relations with major customers, suppliers, government agencies, etc.
- Initiates and fosters collaboration between Clinical Operations team and scientific, medical, regulatory, legal and technical colleagues and opinion leaders to benefit and optimize development programs
- Direct personnel activities including instituting and managing organizational change, leading disciplinary actions and delivering performance reviews
- Responsible for ensuring that Clinical Operations staff are appropriately trained and are afforded opportunities to develop the technical skills to foster professional growth, serve company objectives and function in compliance with Santen SOPs and regulatory requirements
- Perform other duties as necessary as assigned by management
QUALIFICATIONS:
Core competencies, education, and experience.
- Fifteen or more (15+) years of clinical research experience preferably in ophthalmology with a BS/MS degree in a scientific discipline or RN, BSN degree or equivalent; Candidates with less than fifteen (15) years' experience with an advanced degree e.g. PharmD, PhD, MD, OD or DO or equivalent may be considered
- At least eight (8) years' experience directing a clinical operations group (e.g. CRAs, consultants, etc.), including vendor and contractor management. Experience directing clinical operations for multi-country trials a plus
- Detail and quality oriented with a 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
- Requires ability to make high level strategic and tactical decisions within global and distributed team environments
- Strong verbal communication and scientific writing skills, and good interpersonal/group skills
- Must demonstrate tact and the ability to positively influence others and provide feedback to subordinates in a multi-cultural environment and across all organizational levels
- Requires the ability to change the thinking of or gain acceptance of others in sensitive situations
- Significant knowledge of FDA and ICH regulatory requirements e.g. Guidances, guidelines, CFR, etc. and implementation guidelines.
- High level of understanding of scientific and statistical principals vis a vis clinical trial design, operations and analysis/presentation/reporting of data collected in clinical trials.
For more information about our company and the work experience, please visit www.santenusa.com.
Company
Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.
Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.
Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.
With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
- Website
- https://www.santenusa.com/
- Location
-
6401 Hollis Street
Emeryville, CA 94608
United States
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