Associate Director, Clinical Operations

Innoviva Specialty Therapeutics•Waltham, MA

About The Position

The Associate Director of Clinical Operations oversees the operational aspects of clinical trials, ensuring successful execution from initiation through completion. This role provides strategic input on study planning and management, monitors project timelines and budgets, and ensures compliance with regulatory requirements. The Associate Director collaborates closely with cross-functional teams to ensure that clinical trials are conducted efficiently, within budget, and in accordance with GxP (Good Clinical Practices) guidelines. The role also drives process improvements to enhance efficiency and quality, contributing to the successful delivery of clinical programs and the organization’s broader development goals

Requirements

Bachelor of Science in life sciences or related field required; advanced degree is preferred.
7 plus years of experience leading end to end global clinical trials, including a strong understanding of drug development in early phase trials; international clinical trial experience preferred
Proven experience in management and oversight of clinical vendors and CRO’s
Experience across all phases of clinical development.
Strong project management capabilities including budget, forecasting and time management skills.
Excellent interpersonal, negotiation and influencing skills.
Strong understanding of country-specific, FDA (and equivalent), ICH and GCP guidelines as well as cross functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and regulatory affairs.
Excellent decision-making, analytical and strong financial management skills
Ability to manage all aspects of clinical trial execution
Must possess excellent leadership skills with proven ability to foster team productivity and cohesiveness and the ability to operate and execute effectively with limited supervision
Effective Communication
Critical Thinking
Relationship Management & Influence
Quality Focus

Nice To Haves

experience in guiding or inspiring teams is a plus.

Responsibilities

Lead aspects of assigned clinical trials, including development of clinical operations plans and timelines based on the Clinical Development Plan.
Ensure consistency in processes and drive Clinical Operations performance.
Oversee and manage of Contract Research Organizations (CROs)/study vendors, including evaluation, selection, and proactively manage performance to ensure successful trial execution
Oversee development of and adherence to clinical trial project timelines.
Coordinate relevant and timely exchange of information and materials (e.g., subject enrollment, site selection/feasibility, and data collection).
Coordinate with CMC team on drug forecasting, supply of drug products to sites and contribute to the design and packaging of supplies for clinical programs and trials.
Ensure monitoring plans are in place and actively participates in data review.
Adhere to clinical trial budgeting process.
Collaborate with internal and external team members to ensure the successful conduct of clinical trials in accordance with state and federal regulations, GCP, ICH and internal SOPs.
Represent Clinical Operations on cross-functional program teams for all assigned programs.
Develop and implement processes across operations functions to ensure proactive inspection readiness.
Contribute to authoring and coordination of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND submission documents, responses to Health Authorities.
Provide timely and high quality oversight of clinical activities, and escalate issues to the Director, Quality and functional leadership, as appropriate.