Director/Senior Director, Clinical Operations

Triveni Bio is breaking new ground on 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) and directly impacts skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. Our pipeline includes a bispecific antibody (TRIV-573) that targets kallikreins 5 and 7 and interleukin-13 (IL-13), combining a novel mechanism with a highly validated approach across I&I disorders; and a monoclonal antibody (TRIV-920) that targets trypsin 1 and 2, with strong potential to treat patients with hereditary pancreatitis, a disorder with significant unmet need.

As Head of Clinical Operations (Director/Senior Director), you will be leading the clinical operations strategy and will be accountable for managing and overseeing clinical studies that will lead the industry in speed and quality of execution. As a key functional leader and subject matter expert, you will be an integral member of the program teams and will collaborate with other functional leads to achieve department and corporate goals.

This Individual Will:

• Lead and oversee the strategic planning and day-to-day operations of study execution, with a focus on site oversight from study startup to study closeout, patient enrollment, monitoring, compliance, and data flow and metrics from the clinical sites, CROs and vendors.
• Devise the overall global operations strategy (site number, regions, key protocol elements) in collaboration with Clinical Development, that optimizes timelines while maintaining high quality and integrity
• Collaborate with the cross functional program team to deliver clinical studies that are on time and within budget guidelines, while ensuring quality in accordance with the protocol, ICH GCP and regulatory guidelines, and patient safety requirements
• Proactively manage clinical CROs as the primary point of contact by identifying potential risks and resolving issues while ensuring adherence to contractual agreements, timelines, and quality standards
• Develop and maintain strong relationships with investigators, clinical site staff, and vendors globally
• Manage reports for communicating study progress and key metrics to Leadership Team and program teams
• Partner with Finance Team and external vendors to ensure accurate budgeting and accrual of costs throughout duration of each clinical study
• Actively contribute to the preparation and review of key study documents including, but not limited to, protocols, informed consent forms, case report forms, study governance committee charters (e.g., data monitoring committee), study plans and clinical study reports
• Oversee the timely collection and analysis of clinical trial data to ensure data accuracy and integrity
• Participate in the creation, authoring, review, and updating of clinical operations related SOPs, including evaluating the need for new SOPs.
• Works with Quality Assurance to schedule audits of sites and vendors, monitor deviations, and support response and implementation of corrective actions.
• Hire, train, and develop the Clinical Operations team, fostering a culture of collaboration, respect, accountability, and continuous improvement.

The Qualifications We’re Seeking:

• BA/BS in a scientific discipline is required with at 10 to 12 years of experience in clinical operations in pharma or biotech (some experience with small to medium-sized companies is preferred)
• Broad understanding of biopharmaceutical drug development, including working knowledge of relevant ICH and GCP guidance and regulations
• Experience in immunology/inflammation clinical development preferred
• Must be highly experienced in managing collaborations with CROs, vendors, and other external organizations, with prior experience in the implementation of global clinical trials
• Excellent interpersonal skills required, along with an ability to develop important relationships with key stakeholders and work collaboratively, skilled in conflict management/negotiation
• Must have a proactive mindset with strong leadership, facilitation, teamwork, influence management, organizational skills, and ability to work independently
• Highly proficient in utilizing project management best practices, project planning, and facilitative decision-making. Skilled in goal setting, prioritization, and time management
• Desire and capacity to thrive in a dynamic and fast-paced biotech setting
• Willing to travel as required