Senior Global Clinical Operations Manager
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:
A Senior Global Clinical Operations Manager plays an essential role in the development and implementation of global clinical studies by providing significant tactical management for assigned projects and contributes to development and implementation of operational strategies and clinical trial designs.
Responsibilities include the planning, execution, and interpretation of global clinical trials and 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 substantially to strategic discussions regarding the design of global clinical programs and in reporting the progress of clinical programs by working collaboratively with the global Core Team and sub-teams.
- Negotiates and is responsible for clinical operations study timelines during project development and manages clinical operation activities to meet enrollment targets according to the projected timeline.
- Utilizes budget software to develop study budgets for near and longer-term forecasting and ensures studies are managed within approved budget guidelines.
- Recommends and administers budgets, schedules and resource requirements for assigned projects.
- Directs the timely development and implementation of study protocol(s) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures (SOP(s)).
- Oversees global clinical operations activities for assigned projects, including but not limited to, the following:
- Preparation/procurement of all manner of documents and supplies related to the clinical trial process (e.g. Investigator’s Brochure, Protocols, Case Report Forms, Informed Consent Documents, etc.)
- Assist with the development of the clinical sections for submissions to regulatory bodies (e.g. FDA, EMA, etc.) and IRBs/ECs (e.g. INDs, NDAs, Annual Reports, Pre-meeting Packages, Clinical Study Reports, etc.) for assigned project(s).
- Clinical Operations activities to evaluate and select sites, vendors (e.g. IXRS, lab, reading centers), consultants, CROs, etc. for assigned studies.
- Oversees monitoring and management of clinical studies to assure they are conducted in compliance with the protocol, Santen Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements.
- Oversees and/or manages Global Clinical Operations activities collaborating with Clinical Science, Biometrics, Drug Safety and other departments to coordinate the review, evaluation, quality, validation and reporting of moderate to complex clinical data.
- Represents Global Clinical Operations on project teams for assigned projects as requested.
- Prepares and/or presents written and oral presentations regarding clinical trial progress/results.
- Suggests courses and seminars to attend to develop professional expertise in all facets of clinical operations.
- Writes clinical standard operating procedures and provides training to clinical study managers and more junior level clinical operations colleagues.
- Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
- Develops and maintains close working contacts with other functional areas outside of GCO e.g. Regulatory, Pharmaceutical Development, Business Development and Strategic Marketing, Finance, etc. at Santen to facilitate clinical trials research.
- Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Santen development activities on a global basis.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Ten or more (10+) years of clinical research experience preferably in ophthalmology with a BS degree in a scientific discipline, RN, BSN degree or equivalent; MS, PharmD and/or PhD preferred.
- Prior supervisory experience of operations personnel (e.g. CRAs, consultants, etc.) and vendor management strongly preferred
- Significant experience in the oversight of day-to-day clinical operational aspects of drug development.
- Must have the ability to make high level decisions and work effectively within a team
- Strong verbal communication and scientific writing skills, and good interpersonal/group skills.
- Must be able to communicate information between regions and with senior level management both inside and outside of Santen.
- Must demonstrate tact and the ability to positively influence others across all organizational functions and 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. Guidance, guidelines, CFR, etc. and implementation guidelines.
- High level of understanding of scientific and statistical principals vis a vis clinical trial design and analysis/presentation/reporting of data collected in clinical trials.
- High degree of computer proficiency, preferably in MS Office environment.
- Highly detail oriented.
- Adaptable to changing regulatory environments.
- Flexible team player with the ability to work in a changing environment.
- Demonstrated track record of driving projects/deliverables to completion within established deadlines.
- Must exercise good judgment regarding routine and non-routine assignments.
- With minimal input from management, must be able to set and prioritize goals and objectives for self and GCO team members; excellent time management and organizational skills.
- Proven ability to manage teams.
- Ability to work collaboratively and effectively with people from different cultures (e.g., Europeans, Japanese); previous work experience with Japanese companies a plus.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to:
- Spend considerable time at the computer
- Stand, kneel and stoop for filing
- Use the telephone and communicate clearly with individuals who are both internal and external to Santen Inc.
- Travel nationally and internationally, when required, up to 25%
Authorization to work in the United States and travel with legally required documentation.