StrideBio is a product-driven, fully integrated gene therapy company focused on creating and developing innovative genetic medicines with life-changing or curative potential for patients with devastating conditions, including monogenic rare disease and beyond.
We leverage our proprietary structure-inspired adeno-associated virus (AAV) vector engineering platform (STRIVE) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes.
Our team is comprised of accomplished leaders and talented, passionate colleagues with a desire to translate innovative science into treatments. Together with our collaborators we are making rapid progress on our mission to bring novel medicines to patients who desperately need them. StrideBio’s offices, labs and manufacturing facility are located in the heart of Research Triangle Park, NC.
The Vice President of Clinical Operations will be responsible for the leadership, oversight and execution of the company’s clinical trials ensuring they are completed according to timelines, budgets, and regulatory/corporate quality standards. The Vice President will report to the Chief Medical Officer, and will serve as a functional leader, line manager and subject matter expert for the internal and field-based Clinical Operations team. The incumbent will work collaboratively with other senior/functional leaders in the achievement of departmental and corporate objectives and initiatives. With extensive industry knowledge and experience, the Vice President will proactively seek to develop strategies necessary for successful data collection, assessment, analysis, and reporting to gain regulatory approval of current and future Company programs, as well as to improve the efficiency, effectiveness, and quality of the Company’s clinical trial activities. The incumbent will ensure all clinical studies are conducted in accordance with company SOPs, GCPs and ICH guidelines.
- Accountable for the successful execution of the Company’s clinical trials ensuring they are conducted within timelines, budget, and regulatory/corporate quality standards, establishing and managing against a set of metrics for quality, timeliness and efficiency.
- Responsible for Clinical Operations Dept, budget, forecasting and management of functional/trial budgets, as well as departmental contract negotiations.
- Ensures that clinical programs are executed and delivered in accordance with the overall clinical development strategy.
- Provides leadership and strategic vision to clinical operations personnel.
- Leads Clinical Development Operations, Clinical Training, Process Improvement and Medical Writing internal functions.
- Accountable for design and implementation of strategic and operational resourcing plans for the Clinical Operations organization including ensuring open headcount positions are identified and filled expeditiously with qualified individuals, and long-range planning to meet scalability, productivity goals and succession planning.
- Develops and executes staffing plans to ensure adequate and appropriate monitoring of all monitored trials.
- Recruits, motivates, and manages all clinical operations staff to ensure professional development and training of a high-performing team with an aim towards operational excellence, and fostering a collaborative, highly integrated and collaborative culture.
- Fosters and contributes to a culture of collaboration and learning across the organization that aligns with the Company’s values.
- Identifies outsourcing needs and oversees the selection, management, and performance of CROs, vendors and external consultants; sets standards for selection and evaluation of, and regularly reviews effectiveness of, CROs and vendors.
- Partners with other department heads to maintain strong, positive collaborations and ensure effective priority setting, budgeting, and resource deployment.
- Implements a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices.
- Develops and implements clinical monitoring training program to include GCP, monitoring and site management skills, as well as protocol-specific training (in collaboration with Medical Monitor).
- Establishes quality processes within Clinical Operations that focus on data integrity and patient safety.
- Accountable for and contributes to the design of operational excellence activities including program and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials.
- Leads responses to audits (site, internal file and process, and regulatory agencies).
- Serves as the functional representative during inspection readiness activities and during on-site regulatory audits/inspections.
- Oversees Quality Incident reporting activities and resolution of CAPAs related to the conduct of clinical trials.
- Leads the development and optimization of processes for Clinical Operations (SOPs). Proactively assesses the need for new/updated processes and implements process improvement initiatives.
- Develops and/or actively contributes to clinical protocol design and development of critical study documents, such as protocols and related documents, clinical QA plans, Investigator Brochures, data management plans, Clinical Study Reports, regulatory submissions, etc.
- Provides accurate, comprehensive, and current reports to senior leadership related to the status of clinical trials (monthly, quarterly as needed).
- Interacts with the FDA and other global regulatory agencies as needed.
- A Bachelor’s Degree in a relevant field preferably Biological / Life Sciences or equivalent experience. Advanced degree preferred.
- Strong working knowledge of GCP/ICH guidelines.
- Experience managing and mentoring internal and external resources.
- Experience in developing and managing departmental/study budgets and timelines.
- Strong interpersonal skills with demonstrated ability to effectively work with internal cross-functional as well as external groups.
- Extensive knowledge of other related drug development functions.
- Twenty years of Clinical Operations experience.
- Fifteen years in a clinical operations people management role.
- Global experience in both early and late phase clinical trials.
- Experience and strong track record of managing multiple projects and priorities.
- Experience working within a team model.
- Demonstrated ability to effectively lead, influence, and manage within a matrixed organization.
- Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
- Proven ability to perform successfully under stringent timelines and with changing and competing priorities.
- Demonstrated ability to influence and lead external and internal partners to ideate strategically and execute quickly, effectively, and consistently.
- Ability to move 50 lbs. required.
- While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands; reach with hands and arms; climb or balance; stoop, kneel, crouch or crawl.
- Must be able to perform repetitive motion activities for long periods of time.
- Must be able to stand for long periods of time.
What We Offer:
- A competitive salary and meaningful equity compensation
- A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology.
- Exceptional opportunities for learning and growth
- Stock Options
- Company-paid holidays
- Paid time off
- Health, dental and vision care
- Life insurance
- 401(k) plan + match
- Paid parental leave
- Concierge services
- Employee Assistance Program
- On-site gym membership, fully stocked kitchen, retail discount programs
Please visit www.stridebio.com to learn more.
Job Type: Full-time
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