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 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 this Lexington, MA-based biopharma.

Responsibilities :

You will be responsible for planning, directing and implementing the operational components of clinical programs from design concept to final CSR, including budget negotiations.

You will also be accountable for operationalizing 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 the 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