Sr. Director of Clinical Operations
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are seeking a razor-sharp Sr. Director of Clinical Operations eager to make an impact within a mission-driven organization changing the world through clinical research. As part of the Science 37 team, you will be responsible for the oversight of activities and management of Clinical Operations in order to ensure high quality and reliable clinical trial execution. You will provide leadership for clinical operations related issues, identify clinical operations risks, and develop solutions to complex problems while simultaneously mentoring junior members of the department. Additionally, the Senior Director of Clinical Operations is responsible for any operational guidance for Investigators and will work internally across functions and departments with Science 37 study staff and management, as well as represent Science 37 externally with study sponsors and vendors, as necessary. Interested? Keep reading!
Duties and Responsibilities
- Create, execute, and proactively manage clinical trial timelines, budgets and processes
- Maintain strong, effective collaborative relationships across Science 37 to include all Departments and Senior Management.
- Provide direction and oversight to meet project timelines and enrollment goals, data quality, sponsor objectives, and contractual obligations for Clinical Operations studies within budget.
- Develops clear and measurable key performance indicators as part of the project management plan in conjunction with Science37 executive team members and as applicable, sponsor representative(s).
- Oversees adherence to project budget and contracts and assists in the identification and development of scope change documents.
- Ensure all clinical trials are successfully executed with measurable results in accordance with Key Performance Indicators; Identifies critical project success factors, develops tools for proactively tracking progress, analysis and reporting including probability and impact of potential project risks
- Generates and submits weekly status (dashboard) reports for Senior Management on the study progress and project metrics.
- Coordinate assignment of needed resources for project conduct and completion while collaborating with other functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
- Set performance standards and be responsible for performance management across the Clinical Operations team.
- Assist with the creation, review, and updates of corporate Clinical Operations SOPs.
- Ensure that global and local SOPs, ICH - GCP and other applicable Guidelines, as well as FDA and local country (as applicable) Regulations are implemented in clinical trials, and ensure development of new clinical operations SOPs and updating of current SOPs working collaboratively with Quality Assurance.
- Monitor responses and actions to Audit/Inspection Reports and quality issues. Ensure quality checks are developed and implemented. Keep Executive Team informed of key risks and solutions.
- Review and identify training needs for clinical personnel (CRCs/PMs) and ensure a plan is in place within the training program.
- Mentor and/or assist in coaching/training clinical operations personnel at all levels, including directors, project managers, clinical research coordinators and/or other study-associated personnel.
- Maintain ongoing awareness of developments within the clinical research field. Participate in conferences / events / bid defense meetings and other initiatives to promote continuous growth.
- Participate in the creation of annual department budget.
- Bachelor’s degree required. Advanced degree or equivalent clinical research experience strongly preferred.
- 15+ years of pharmaceutical-sponsored clinical operations management experience (or equivalent) and/or clinical research background.
- Strong leadership and professional skills, including ability to effectively communicate with and motivate large teams of employees; financial management; problem solving; and development of employees.
- Medical and scientific knowledge strongly preferred.
- Highly proficient in computing and technology skills.
- Expertise in clinical operations - Demonstrated ability to successfully manage people and projects. Proactive problem solving abilities and follow-through.
- Knowledge of field organizational strategies - Proven ability to adapt to rapidly changing work environment. Successful decentralized team management and situational responsive decision making.
- Extensive knowledge of clinical research- Understands the drug development process and the regulations relating to Investigator and Sponsor responsibilities. Knowledgeable about the critical elements for success in clinical trials; demonstrated participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a team.
- Strong communication and presentation skills - Demonstrates strong written and verbal communications skills. Ability to establish and maintain positive relationships with external clients, and internal management and executive team. Ability to conduct effective presentations and lead team meetings.
- Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software.
- Practices professionalism and integrity in all actions - Demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility.
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
- Ability to communicate in English (both verbal and written).
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks. Submit your resume to apply!