Director of Clinical Operations

Company Overview

Accent Therapeutics is a biopharmaceutical company based in Lexington, MA that is focused on developing first in class and best in class small molecule Inhibitors of RNA modifying enzymes (RMEs) and adjacent pathways to primarily treat cancer. Founded in 2017, named as one of Fortune’s Top Ten Workplaces in Healthcare and Biopharma in 2020, and one of Fierce Biotech’s Fierce15 in 2020, Accent is building a highly collaborative team of experienced high-caliber drug developers to develop life-changing therapies for patients.

Position Summary

Join us at Accent Therapeutics as a Director of Clinical Operations! This key individual will report to the Chief Medical Officer (CMO) with accountability for the clinical operations strategy, design, and implementation to deliver our programs through clinical trials to proof of concept and beyond. As a key team member, you will engage with and influence a diverse range of stakeholders both within and outside of Accent Therapeutics.

Responsibilities

You will be responsible for planning, directing and implementing the operational components of our clinical programs from design concept to final CSR, including budget negotiations. You will also be accountable for operationalizing our trials from CRO management to site start-up and site trial conduct, the acquisition of clinical trial data from internal and external sources, data cleaning (in collaboration with statistics), and publication. In collaboration with the Medical Director, Translational Medicine Team, and CMO, you will be accountable for the clinical operations strategy, including approaches to accelerate deliverables, e.g., patient engagement, recruitment and retention. You will work with our internal team including program leadership, clinical pharmacology, CMC, and corporate operations, in addition to engaging with external entities including consultants (e.g. regulatory), partners/suppliers (e.g. CROs), and external clinicians (e.g. advisors, investigators).

Required Skills & Experience

• Bachelor’s degree in related discipline, preferably in medical or biological science
• At least 8 years or equivalent experience in drug development with progressive levels of responsibility
• Extensive knowledge of the clinical and pharmaceutical drug development process
• Experience in early phase oncology clinical development
• Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand business requirements
• Significant experience of program management and use of project management techniques in sophisticated projects, including resourcing and financial management
• Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery
• Proven ability in problem solving and issues management that is solution focused
• Proven experience in driving operational delivery to timelines, cost and quality
• Proven experience of delivery through collaboration with internal and external providers
• Experienced oversight of external providers

Desirable Skills & Experience

• Higher degree (e.g. PhD, MSc, MPhil.) is desirable
• Program management qualification (e.g. MBA, PRINCE2, PMP), is also desirable
• Experience in variety of Biotech/CRO/Sponsor organizations and/or operational experience in various countries
• Experience across the product life cycle in oncology