Vice President, Development Operations

Todd & Weld, LLP; Lexington (MA); On-site; USD 150,000 - 250,000; Full time

Job summary

TRIANA Biomedicines, a leading biotechnology company in Greater Boston, seeks a Vice President of Development Operations. This role involves building clinical development operations, managing timelines and budgets, and ensuring compliance with regulatory requirements. The ideal candidate will have extensive experience in clinical trials and a strong leadership background.

Qualifications

• 15+ years of experience managing clinical trials with CROs.
• Experience in planning and executing global clinical studies preferred.
• Fluency with quantitative methods and technology for clinical data analysis.

Responsibilities

• Define overall drug development strategy across disciplines.
• Accountable for clinical development operational activities.
• Oversee the operational aspects for study protocols and vendor management.

Skills

Leadership

Communication

Organizational Skills

Interpersonal Skills

Quantitative Methods

Education

Bachelor’s degree

Job description

About TRIANA Biomedicines

TRIANA Biomedicines is a Greater Boston biotechnology company building the leading molecular glue discovery platform to regulate disease targets that are difficult to address with any other modality. TRIANA’s drug discovery engine is powered by high-resolution structural insights, state-of-the-art AI and computational tools, and bespoke chemical libraries.TRIANA’s target-first and rational approach to molecular glue discovery is currently focused on inducing or enhancing the degradation of high-profile cancer targets.The therapeutic approach pioneered by TRIANA has the potential to fundamentally change the paradigmof small moleculedrug discovery and bring significant therapeutic benefits to patients. TRIANA is a private company with a top-tier investor syndicate.

Role Description

The Vice President, Development Operations is responsible for building our clinical development operations function. You will work closely with a cross-functional team in a fast-paced environment to ensure clinical trials are appropriately supported by internal and external stakeholders, conducted on time and budget, and in accordance with applicable guidelines and regulatory requirements.

Responsibilities

• Works across disciplines to help define the overall drug development strategy.
• Works with internal and external medical, scientific and operational experts to keep abreast of industry standards. Provides development operations perspective to decisions.
• Accountable for the overall clinical development operational activities including close collaboration with clinical research organizations (CROs) and other external partners.
• Provide functional expertise for Development Ops strategies and tactical implementation of the studies by managing timelines and deliverables.
• Lead preparation of vendor requirements and project scope and support selection of and contracting with CROs and clinical study vendors, and in turn, clinical study budget development, forecasting and tracking.
• Implement appropriate systems, standards, and processes to ensure quality in study execution with our investigator sites, CROs, and other clinical trial vendors.
• Responsible for establishing and updating clinical operations SOPs, Work Instructions, guidelines, standards, and best practices.
• Oversee the operational aspects for the development and delivery of study protocols, informed consents, vendor selection/management, site/country selection, etc.
• Author and/or provide oversight of study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path) in collaboration with applicable program teams and ensuring appropriate escalation as required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution.
• Facilitate and oversee ongoing and timely data analysis to ensure on-time availability of clinical study results and data integrity.
• Assist with interpretation and presentation of output (e.g., analysis, visualizations) to internal and external customers.
• Set-up and implement effective investigator and site monitor training; facilitate operational and disease area training for internal and external stakeholders as required to support high quality study execution.
• Develop site recruitment, enrollment and engagement strategies for clinical trials
• Accountable for clinical program/study timelines, budgets and management of actual spend to approved budget.
• Oversees clinical trial systems and workflows (e.g., design, specifications/requirements, UAT) including IRT/IXRS, central lab, eCOA, eTMF, etc.
• Oversees clinical supply forecasting requirements for clinical trials and collaborates in labeling/packaging, distribution and chain of custody of clinical supplies.
• Collaborate with cross functional team members to prepare strategy presentations, present and discuss data at relevant meetings, external consultants, KOLs and potentially regulatory meetings as well as author sections of regulatory documents (IB, Protocol, Annual Reports, IND sections, CSR).
• Partner with legal counsel on contracts and other clinical related legal agreements
• Ensure effective communications to internal and external stakeholders through meetings, presentations, and other methods.

Qualifications

• Bachelor’s degree required; scientific background / RN is a plus.
• 15+ years of experience working directly with CROs to manage clinical trials.
• Leadership experience managing a clinical operations team.
• Experience planning and executing on ex-US and global clinical studies preferred.
• Fluency with quantitative methods and technology used in the analysis and presentation of clinical data preferred.
• Excellent understanding of ICH and GCP guidelines, as well as applicable regulations and industry best practice.
• Excellent organizational skills and attention to detail; willing to operate deep in the details and in a fast-paced environment.
• Effective communication and interpersonal skills.
• Comfortable working closely with a team of external consultants and hiring to build out Clinical Operations team as our programs progress.
• Some travel required

We welcome applications from skilled individuals whose qualifications may not fit the criteria outlined above.

Our Culture

Our Team is our greatest asset at TRIANA. We are proud to work with an integrated group of individuals from an extensive range of backgrounds and experiences. Diversity, Equity, Inclusion and Belonging are important aspects of our culture. We embrace our differences and cultivate an environment that drives better collaboration and innovation by striving to ensure that all coworkers have an ongoing positive experience while being their authentic selves.

Our Values

At TRIANA we are empowered to act. We dare to create transformative medicines for patients. Our creativity and dedication are the glue that unites us in pursuit of our mission.

Thank you for your interest in TRIANA!