Vice President 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 revolutionizing the clinical trial industry one patient at a time. To help us achieve our goal, we are seeking a razor-sharp Vice President of Clinical Operations eager to make an impact within a mission-driven organization. The Vice President of Clinical Operations is responsible for Clinical Operations with a focus on the oversight of resourcing, developing, training and managing a successful clinical operations team. This position will be considered a member of the Executive Team and play an integral role in driving cross-functional strategy and support. The Vice President of Clinical Operations will have executive contact with current and potential clients. Key client oversight and strategic project contribution combined with management of a group of Directors makes this role a critical contributor to the overall success and future growth of Science 37, not only through leadership of clinical operations, but through significant contributions to the wider company direction and management.
DUTIES AND RESPONSIBILITIES
- Create, execute, and proactively manage clinical trial processes to include all internal and external business units.
- Maintain strong, effective relationships across Science 37 to include all Department and Senior Management.
- Set performance standards and be responsible for performance management across the Clinical Operations team.
- Participate in the creation of annual budget.
- Create and maintain an independent, outcome-based clinical trials operations business unit.
- Ensure all clinical trials are successfully executed with measurable results to include Key Performance Indicators.
- Lead and mentor Clinical Directors and Managers, and support successful internal training and its implementation.
- Ensure Senior/Director(s) of Clinical Operations directs teams to work within the monitoring plans; ensure defined deliverables are met by proactively tracking and monitoring study-specific trial management activities and systems.
- Supervise and maintain day-to-day project interactions with clinical teams and team members from other departments. Provide strategic direction to meet project timelines and enrollment goals, data quality, sponsor objectives, and contractual obligations for Clinical Operations.
- Oversee creation, review, and updates of corporate Clinical Operations SOPs.
- Ensure that global and local SOPs, ICH - GCP Guidelines, and FDA Regulations are rigidly implemented in clinical trials, and assist QA department with developing new SOPs and reviewing current SOPs.
- Establish and update procedures and tools for training and development of all personnel in the Clinical Operations Department.
- Review and identify training needs for clinical personnel (CRCs/PMs) and meet the need for such training.
- Generate and submit monthly reports for Senior Management on the Clinical Operations department as requested.
- Participate in conferences / events / bid defense meetings and other initiatives to promote continuous growth.
- Plan and implement Quality Checks for clinical projects.
- Monitor Senior/Director of Clinical Operations and Clinical Project Managers responses and actions to Audit/Inspection Reports and quality issues.
- Maintain ongoing awareness of developments within the clinical research field.
- Work with and support the CEO, CMO, and COO on company operations.
- Manage area in a prudent fiscal manner; maintain productivity and targets as appropriate.
- Builds an internal culture of innovative thinking that leads to the development and implementation of the t mission and vision.
- Works collaboratively with other department heads as an advisor for communication related to clinical operations.
- Effectively communicates the clinical operation strategy to executive management, senior leadership and team members.
- Conducts performance reviews, calibration sessions and feedback discussions for direct reports.
- Performs competency assessments across his/her team, and implements and monitors development plans with direct reports.
- Oversees and mentors and/or assists in coaching and training departmental team members.
QUALIFICATIONS & SKILLS
- Bachelor’s degree required. Advanced degree or equivalent clinical research experience strongly preferred.
- 10+ years of pharmaceutical-sponsored clinical operations management experience (or equivalent) and/or clinical research background.
- Experience with global/international clinical operations, strongly preferred.
- Strong leadership, management 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. 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.
- Planning & Execution - Excellent planning, prioritization, management, and organizational skills. Strong conceptual thinking and ability to optimize work processes.
- Problem Solving & Innovation - Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses. Action oriented and innovative; able to translate broad goals into achievable steps.
- Management & Interpersonal Skills - Experience in building and guiding organizational teams. Leverages each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities. Understands interpersonal and group dynamics and reacts in an effective and tactful manner and has a range of interpersonal skills and approaches with ability to select a best-fit approach.
- Influence & Collaboration - Ability to motivate, influence and guide team members and direct reports; gains commitments from others. Ability to cultivate and manage business opportunities, partnerships, and vendor relationships. Commitment to collaboration, within and across departments.
- 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!