What are the responsibilities and job description for the Associate Director, Clinical Operations position at Triveni Bio?
ABOUT TRIVENI
Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders.
SUMMARY
The Associate Director, Clinical Operations is a key member within Clinical Operations leading the successful execution of clinical trials. This individual is responsible for the logistical planning, oversight and execution of clinical studies within a clinical program ensuring adherence to timelines, budgets, regulatory standards, and quality control. This position will report to the Head of Clinical Operations and will contribute directly to the development of a growing Clinical Operations function.
On a day-to-day basis and as the team grows you will lead and execute day-to-day clinical trial operations while working closely with the Head of Clinical Operations and Clinical Study Team to develop streamlined processes to grow and support the function and team.
The ideal candidate is an adaptable and resilient Clinical Operations leader who is interested in working in a fast-paced, dynamic, and collaborative biotech environment with a willingness and ability to contribute to the growth of the function and take on new challenges successfully. The candidate will work among a cross-functional Study Team from feasibility through study close-out. Experience in building and leading a team and processes such as Risk-Based Quality Management and Operational excellence is a plus.
You must have experience within a start-up environment and be comfortable with both leading and executing all operational aspects of clinical trials inclusive of clinical vendor management while our team grows. Strong problem solving and analytical skills are necessary.
At Triveni, we enjoy teaching new skills, fostering a culture of continued learning and growth. As this is a lean team, you may be exposed across multiple programs at various stages of development.
RESPONSIBILITIES
• Clinical Lead for global clinical trials, accountable for the successful implementation, execution, and delivery of clinical project deliverables on time and within budget.
• Develop and maintain strong working relationships with internal and external stakeholders (cross-functional team members, CROs, external experts, and investigators), ensuring high-quality services are executed in a timely and cost-effective manner.
• Develops and drives granular Clinical Study timelines and enrollment projections and contributes to the development of Key Performance Metrics and risk mitigation strategies.
• Monitor and manage vendor and site performance, trial progress and quality through evaluation of defined study performance metrics.
• Proactively identifies risks and issues, and works with the Study Team to assess impact, devise strategies to implement corrective actions or preventive measures to mitigate risk.
• Collaborates with CRO, study vendors and cross-functional team to define and operationalize study specifications (e.g., CRO performance metrics, Central/Specialty Labs, IRT/drug supply, Patient Services, EDC, TMF etc.)
• Oversee and participate in the development of study documents and tools, including study protocols, consent forms, and project plans.
• Obtains and maintains an in-depth understanding of the study protocol and related procedures to contribute strongly to Study Team knowledge by sharing best practices, making recommendations for continuous improvement, and training/mentoring as appropriate.
• Assists in creating a culture of compliance by contributing to the development of practices ensuring inspection readiness at all times.
• Leads the development of a robust TMF management plan and metrics to measure performance of TMF health.
• Leads and/or supports Risk-Based Quality Management and Operational Excellence initiatives.
• Provides study status updates, including presentations and reports to senior management ensuring appropriate communication of risks, impact and mitigation strategies.
• Contributes to the development of the ClinOps function; SOPs, best practices, and facilitates implementation.
• Collaborates/leads initiatives for continuous improvement projects and activities that support the development of the Clinical Team.
• Fosters an environment of continuous improvement and actively participates in the recruitment, training, and professional development of clinical operations team members.
EXPERIENCE & QUALIFICATIONS
• 8 years of experience managing global clinical trials and study teams across all stages (startup-closeout) of phase I-III studies and a strong working knowledge of GCP/ICH and other applicable regulations/guidelines, required.
• BA/BS preferably in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field. Project Management degree or PMP certification is a plus.
• Experience in a fast-paced biotechnology environment required.
• Domestic and international travel up to 25% required.
• Ability to work on-site and adhere to an “office-first” culture is required.
• Prior experience building and leading a team and processes such as Risk-Based Quality Management and Operational excellence is a plus.
