Director, Clinical Operations

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Position Summary:

Is responsible for the implementation and oversight of clinical study operations by organizing and coordinating with other relevant parties the planning, implementation, management, execution and completion of clinical studies according to applicable regulations and guidance, ICH and GCP, and Bausch & Lomb SOPs within agreed-upon timeframes and budget.  Also responsible for effective communication within the corporation (and with external entities, where appropriate) of the issues and actions related to the successful completion of these studies.  May serve as the primary project team representative for Clinical Operations.

Major areas of Responsibility:

Clinical Operations:

• Manage and/or oversee the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs).  Will also work closely with members of other functional areas to provide input on study-related documents and issues (DMP, SAP, drug/device supplies, CSR, etc.).
• Provides clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS, etc.).
• Manage the identification, evaluation, and selection of investigators/sites.
• Ongoing assessment, evaluation and management of internal and external resources.
• Ensure study supply requirements are met.
• Responsible for the appropriate communication with and maintenance of clinical study sites including training of site personnel in the study protocol and other study-specific procedures.
• Supervise clinical operations team to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and B&L SOPs.
• Communicate with relevant global team members, other B&L departments (e.g., R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device Safety, and Clinical Supplies), and external consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes in scope, schedule, and resources.
• Organize investigator and expert meetings relevant to the indication and assist with the organization and management of DSMBs and Data Review Committees, as necessary.
• Prepare study timelines and budgets and ensuring study execution is aligned with these targets.
• Supervise clinical staff and vendors to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and B&L SOPs.
• Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.) during study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner.
• Oversee the preparation of procedures for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, procedures for reporting of adverse events, CRF completion guidelines, Study Manual, etc.
• Liaise with PVG/GPSS and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs and assure proper reporting of the events to the IRBs/REBs/ECs. 
• Liaise with Data Management to review data discrepancies and ensure that data clarification forms (queries) are appropriately handled by the CRAs and responded to by the site/investigator in a timely manner.  May assist in the review of queries to determine criticality of the DCF during data clean-up and lock process. 
• Liaise with vendors and study site personnel and clinical investigators to provide study related guidance and answers to operational issues.

Budgets and Forecasts:

• Provide input to Finance to  forecast study expenditures and resourcing needs.
• Review RFPs and proposals from external vendors.
• Ensure subordinates and vendors manage and monitor study related expenses to meet forecast.

Regulatory Reports:

• Provide Clinical Operations support in the timely coordination and execution of clinical study reports. 
• Assist in the review of regulatory reports to ensure that reports accurately reflect proper interpretation of the clinical study findings.
• Assist to ensure annual IND/IDE and IB/ROPI updates are completed in an accurate and timely manner.
• Provide Clinical Operations support to the Regulatory Affairs department.

Leadership:

• Manage in-house team of CRAs, CTAs and/or CTMs for one or more studies to ensure execution of all studies in a timely and efficient manner.
• Provide leadership, training, and development support to the study team.
• May lead meetings (face-to-face, teleconferences, etc.) with external vendors ensuring problems are identified and issues are resolved quickly and efficiently.
• May serve as a representative on internal committees/teams for Clinical Operations or cross-functional activities.
• Foster a dynamic, matrixed working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging study team members to meet and/or exceed expectations.
• Encourage professional growth of personnel through regular training sessions, and by acting as a resource to clinical staff.  May lead training sessions.
• Provide guidance and comments on SOPs revisions.  May act as a leader of a SOP sub-committee for SOP revisions.
• May visit sites with CRAs as needed to provide hands-on training as well as to discuss study related issues and problems with the Principal Investigator and/or site staff.
• Share/present knowledge and information with appropriate departmental, project, or study team members for training purposes. 

POSITION REQUIREMENTS:

• Strong knowledge of Good Clinical Practices (GCP), clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management.
• Minimum 10-12 years experience in the industry with a minimum of 6 years of managing clinical trials.
• Minimum of 5 – 6 years experience in managing and training clinical personnel (Executive CRAs, CRAs, project assistants).
• Experience leading device studies in Ophthalmology is a plus
• Strong planning and organizational skills with ability to multi-task and plan activities as it relates to management of clinical trials.
• Experience leading and working within cross-functional teams.
• Experience in managing CROs and external vendors.
• Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, outside vendors, consultants, team members and various audiences.
• Ability to problem solve, build teams, and to lead and motivate others.
• Effectively work independently as well as within a team matrix.
• Financial management skills as applicable to overseeing project expenditures and forecasts.
• Advanced computer skills (Microsoft applications, spreadsheets and data displays, etc.)
• Willing and able to travel.

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review

This position may be available in the following location(s): US - Remote

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $180,000.00 and  $250,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

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Our Benefit Programs: Employee Benefits: Bausch + Lomb

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