Associate Director Clinical Operations

Oak Hill Bio Ltd; Massachusetts; Remote; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Annual bonus and equity

Flexible work options

Zusammenfassung

Oak Hill Bio Ltd is seeking an Associate Director of Clinical Operations to lead the planning, execution, and oversight of pivotal registrational trials. The role partners with development, regulatory, biostatistics, data management, and external CROs to ensure high-quality delivery on time and in compliance.

It offers a hands-on leadership path in a small, collaborative biotech setting. The role emphasizes operating with investigators and sites, driving enrollment, quality, and site engagement,

Qualifikationen

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• Typically requires extensive experience in clinical operations and project leadership.
• Experience leading global Phase 2/3 trials and outsourcing models.
• Strong knowledge of ICH-GCP, regulations, and study management.
• Ability to manage multiple priorities in a fast-paced biotech environment.

Aufgaben

• Lead and oversee planning, execution, and close-out of clinical trials.
• Provide operational input into study documents and protocols.
• Identify risks and mitigation strategies; ensure compliance with protocols and regulations.
• Oversee CROs/vendors, budgets, contracts, and change orders.
• Develop site activation strategies and manage investigator relationships.
• Maintain study-level metrics, dashboards, and performance reviews.
• Lead cross-functional study teams and escalate issues as needed.

Kenntnisse

Leadership

Vendor management

Clinical operations

Study management

Global trials

Regulatory compliance

Ausbildung

Bachelor's degree in Life Sciences or related field

Master's degree preferred

Jobbeschreibung

Job Title: Associate Director Clinical Operations

Location: East Coast US or EU/UK (remote)

Position Summary

Oak Hill Bio is a clinical-stage biotechnology company focused on acquiring and developing outstanding rare disease drugs that have been deprioritized by big pharma.

The person in this role will be responsible for the planning, execution, and oversight of clinical trials, and be the study lead for the Company’s first registrational clinical trial. This role will work closely with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance, and external partners (CRO and vendor oversight and management). This individual will play a critical role in ensuring clinical studies are delivered with high quality, on time, and in accordance with protocols, applicable regulations, and company standards.

This is a hands-on leadership role within a small, collaborative biotech environment. The person in this role is comfortable balancing strategic thinking with detailed execution, taking ownership of critical study activities, and working effectively with CROs, investigators, sites, and other external partners.

The person in this role has an opportunity to make a direct impact on the development of therapies for pediatric patients with rare diseases, where clinical trial execution can present unique challenges related to limited patient populations, specialized sites, enrollment, caregiver burden, and geographically dispersed patients.

Responsibilities

Clinical Trial Planning and Execution

• Lead and support the operational planning and execution of clinical trials from study start-up through database lock and study close-out.
• Develop and maintain detailed study timelines, operational plans, and key milestones.
• Partner with Clinical Development and cross-functional teams to translate clinical strategy into executable study plans.
• Provide operational input into study protocols, informed consent forms, investigator materials, and other study documents.
• Identify operational risks and develop mitigation strategies proactively.
• Ensure study activities are conducted in accordance with the protocol, ICH-GCP, applicable regulations, and company SOPs.
• Partner with Quality Assurance and other functions to support inspection readiness.
• Support audit and inspection activities as appropriate.

CRO and Vendor Management

• Lead the selection, onboarding, and ongoing oversight of CROs and other clinical vendors including finances and governance.
• Establish clear expectations, deliverables, timelines, and metrics with external partners.
• Monitor CRO and vendor performance and ensure timely resolution of issues.
• Review and manage vendor budgets, contracts, and change orders in collaboration with appropriate internal functions.
• Establish effective governance structures and regular communication with CRO partners.
• Hold external partners accountable for quality, timelines, and study deliverables.

Site and Investigator Management

• Support identification, feasibility assessment, selection, and activation of clinical trial sites.
• Develop productive relationships with investigators and site personnel.
• Monitor site performance, enrollment, data quality, and compliance.
• Support innovative approaches to patient identification, recruitment, retention, and site engagement.
• Partner with CROs and sites to identify and address enrollment barriers.
• Support investigator meetings and other site engagement activities.
• Work with patient advocacy organizations and other external stakeholders, as appropriate, to support patient-centric trial execution.

Study Oversight and Performance Management

• Establish and maintain appropriate study-level metrics and dashboards.
• Monitor enrollment, site activation, data entry, query resolution, protocol deviations, monitoring activities, and other key operational indicators.
• Identify risks and communicate them effectively to study teams and senior management.
• Lead or contribute to regular study team meetings and operational reviews.
• Serve as a key Clinical Operations representative on cross-functional study teams.
• Escalate operational issues and develop corrective and preventive action plans as needed.

Leadership and Development

• Provide leadership and mentorship to Clinical Operations team members and contribute to building the company's clinical operations capabilities.
• Facilitate effective communication and decision-making across all stakeholders.
• Foster a culture of accountability, collaboration, quality, and continuous improvement.

Building the OHB Team

• Keeps patients at the center of every decision
• Does high-quality work and owns the results
• Works well with others to deliver team goals
• Seeks feedback, keeps learning, and helps others grow

Qualifications & Experience

• Bachelor's degree in Life Sciences, Biostatistics, Nursing, Public Health, or a related discipline; advanced degree preferred.
• Typically requires a degree/masters and a minimum of 10 - 12 years of related work experience, or equivalent, working within a pharmaceutical/biotech company, CRO, or similar organization, with increasing responsibility for clinical trial execution.
• Demonstrated experience leading global Phase 2/3 clinical trials.
• Strong understanding of ICH-GCP, clinical trial regulations, and clinical research processes.
• Experience with study start-up, site management, enrollment, monitoring oversight, and study close-out.
• Demonstrated ability to manage multiple priorities and deliver against timelines in a fast-paced environment.
• Demonstrated ability to work independently and effectively in a small-company
• Significant sponsor-side experience operating within a fully outsourced clinical development model and in a matrix environment.
• Inspection Readiness experience.
• Prior experience with rare disease and pediatric clinical studies preferred.
• Highly collaborative and strategic mindset with strong attention to detail.
• Strong leadership and vendor-management skills within a matrixed, outsourced environment.
• Excellent project management and organizational abilities.
• Exceptional written and verbal communication skills.
• Ability to thrive in a fast-paced, resource-constrained biotech environment

The base salary range provided is for US-based employees only, and is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. Oak Hill Bio will use local market rates for roles outside the US.This role is eligible for an annual bonus and equity. Actual base salary pay will be based on several factors, including geography. skills, competencies, experience, and other job-related factors permitted by law.

The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria necessary to successfully perform this position.