Director of Clinical Operations or VP of Clinical Operations
About the Company:
Surface Ophthalmics is a pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular diseases. Our current drug pipeline, all of which use a patented delivery vehicle, consists of three proprietary drug candidates for the treatment of: i) mild to moderate dry eye disease (DED), ii) acute DED, and iii) pain and inflammation for patients recovering from ocular surgical procedures. Together our product candidates address a multibillion-dollar market in the U.S and around the world. We are a start-up company with a small, closely-knit team. As we grow our programs and operational complexity, we are adding key positions to support our business.
Surface is headquartered in Pleasanton, California and offers a hybrid office & home work environment for most positions. The people at Surface are a dedicated, fun, and caring group to work with. We value initiative, collaboration, transparency, integrity and a drive for achieving our common objectives.
About the Opportunity:
The Associate Director/Director of Clinical Operations contributes to Surface Ophthalmics, Inc. (SURFACE)’s clinical drug development program(s) at and leads the operational planning and execution of assigned clinical studies/assigned clinical program(s) at high quality, in a time- and cost-effective manner, aligned with the company goals, and in compliance with company procedures, FDA regulations, ICH GCP, and any other applicable regulations.
The Associate Director/Director of Clinical Operations manages Clinical Operations contractors and/or Clinical Operations staff.
The Associate Director/Director of Clinical Operations participates in the development and maintenance of SURFACE-internal functional processes and best practices to ensure quality standards for clinical study execution, project and site management, monitoring oversight, and Clinical Research Organization (CRO)/vendor management that are compliant with company requirements and applicable regulations and guidelines.
The Associate Director/Director of Clinical Operations works closely with the VP of Clinical Operations and other key functions both internally and externally to ensure the successful completion of all clinical activities/project deliverables with quality and within the required time frame and budget.
- Manage operation of clinical study/clinical program assignments including project planning, budget, resource, and CRO/vendor management in a time- and cost-effective manner that is aligned with company goals and expectations
- Train, manage, and develop Clinical Operations staff/contractors according to company requirements
- Provide strategic and tactical leadership and input into operational execution of clinical studies to ensure goals and objectives for clinical program(s) are met
- Oversee, manage, facilitate, and track study execution and study documentation to ensure quality and compliance with protocol, study plans and timeline, contractual and budgetary agreements, company procedures, ICH GCP, and applicable regulatory requirements and guidelines
- Provide leadership and guidance to the SURFACE/CRO study execution team(s)
- Liaise with CRO, Medical Monitor(s), VP of Clinical, and cross-functional stake holders as appropriate to address questions regarding protocol implementation, study drug management, safety, patient care, etc., with urgency
- Provide regular updates to the VP of Clinical Operations/SURFACE management, clinical team, and relevant contract staff/vendors regarding status, progress, and risk management of clinical studies
- Lead the evaluation and selection process for external vendors/CROs; this includes the development of clinical outsourcing specifications and contract/budget review
- Manage the implementation and maintenance of efficient company-internal functional processes, promote best working practices, and ensure adherence to company standards and applicable regulations and guidelines
- Author and/or review study documents, clinical operations sections of regulatory documents, and other documents as requested
- Support/coordinate recruitment of Clinical Operations resources
- Bachelor of Science/Bachelor of Arts degree in a relevant scientific discipline (or equivalent) and 10+ years of relevant clinical research experience the pharmaceutical, biotechnology, and/or CRO industries
- In-depth knowledge of and experience in clinical drug development (Phases 1 -3) in the pharmaceutical, biotechnology, and/or CRO industries, including clinical research study planning, execution, and reporting; project and site management; site monitoring/monitoring oversight, and quality control processes; vendor/CRO management as well as budget negotiations and management
- Excellent working knowledge of regulatory requirements (e.g., FDA regulations, ICH GCP, and other requirements applicable to clinical research studies)
- Experienced in managing contractors and direct reports
- Experienced author of study documents and clinical sections of regulatory and other documents
- Excellent computer skills (Microsoft Office Suite, IRT/EDC/eTMF applications)
- Flexible team player who demonstrates a high level of mastery of the following competencies:
Lead: Build a culture of high engagement, empowerment, and performance. Set clear expectations. Ensure that roles and responsibilities are clearly defined and understood. Share accountability and responsibility for the achievement of company and function goals. Demonstrate emotional intelligence and awareness and motivate others to do the same.
Collaborate: Participate and actively contribute to a joint effort of multiple individuals to accomplish a task or project. Understand and pursue mutually beneficial working relationships to move projects toward objectives. Build relationships with others and show consideration; treat others sensitively, fairly, and consistently.
Communicate: Understand the views of others and communicate in a realistic and practical manner using appropriate language. Listen attentively to views and issues of others. Share information in a timely manner that impacts others. Select appropriate methods of communication for each situation and communicate with respect, clarity, transparency, and honesty.
Deliver on commitments: Deliver on deadline and scope commitments with high quality outcomes. Be trustworthy in team situations and set appropriate expectations for work planning. Hold self and others accountable for delivering on goals and commitments. Actively seek clarity if expectations are not clear. Operate transparently and share accountability through active collaboration with others across functions.
Proactively plan and organize: Organize time effectively, create work schedules, prioritize, prepare in advance, and set realistic timescales. Visualize a sequence of actions needed to achieve a specific goal and how to estimate the resources required. Anticipate and adjust to change. Look for patterns and trends from diverse perspectives. Proactively adjust behaviors, plans to accommodate changes.
Solve problems: Analyze situations, diagnose problems, identify the key issues, establish and evaluate alternative courses of action and produce a logical, practical and acceptable solution. Take an overview and identify patterns, trends and long-term possibilities. Understand, link and analyze information to understand issues, identify options and support sound decision making. Seek ways to provide added value. Demonstrate recognition and development of new ideas and opportunities. Think critically about how to do things better and encourage new approaches and ideas.
Adapt: Welcome alternative thought processes, methods and approaches to problem.
Manage and improve process: Define efficient, effective and repeatable work processes and establish clear roles for team members. Benchmark best practices in the industry. Know how to identify process problems and opportunities for improvement and simplification. Measure results and use metrics to constantly improve processes and performance.
Keep composure: Exercise self-control under trying or tough circumstances or situations or under any kind of pressure. Deal with interpersonally and/or politically challenging situations calmly and diplomatically, diffuse tension. Remain focused, try to think clearly and take appropriate decisions even under ambiguous, doubtful, stressful, dilemma and crisis situations. Thoughtfully intervene in conflicts to facilitate communication and resolve problems, find common ground when possible. Motivate others to concentrate on finding solutions to problems rather than getting overwhelmed by stresses and strains involved. Exude calming effect on the people around.
What’s in it for you:
Our employees enjoy benefits that make them more productive and contribute directly to the development of their professional skills. We want to be able to attract the best of the best and make sure they keep getting better. On top of an exciting and intellectually challenging workplace, we are offering:
- Work in a highly dynamic industry with a company focused on innovative science
- A hybrid home/office work schedule
- Collegial and supportive colleagues in a fun environment where personal development and success are high priorities
- Competitive medical / dental / vision packages
- 401K with company match
Surface is an equal opportunity employer. We want applicants of diverse backgrounds and hire without regard to race, color, gender, religion, national origin, ancestry, disability, age, sexual orientation, or any other characteristic protected by law.
Please send your resume and brief cover letter to: firstname.lastname@example.org.