Director of Clinical Operations

About the position

As the Director of Clinical Operations, you will be responsible for providing strategic leadership and detailed operational management oversight of one or more programs. You should be comfortable being hands on, managing all aspects of a study or studies including building relationships with trial sites and fostering relationships with CROs and third-party vendors. You have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a small company environment. You thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient. There is an expectation for hybrid working, including 3 days/week in our Waltham office and the remaining days out of your home-based office.

Responsibilities

• Develop and implement high-level Clinical Operations and study-specific strategies aligned with the clinical development plan.
• Analyze complex issues to quickly develop relevant and realistic plans and recommendations to implement.
• Monitor vendors and track metrics ensuring operational success and delivery on time in support of the functional and corporate goals.
• Be the primary driver of all clinical study related activities, timelines, actions and plans.
• Ensure communication and understanding of risks and challenges are clear to functional and program leadership.
• Lead the development of the clinical study program, including critical path activities, enrollment projections, interdependencies, and milestones.
• Be a resource for junior staff, providing mentoring and leadership support.
• Manage cross-functional relationships with internal and external stakeholders utilizing excellent matrix management skills and written and verbal communication skills.
• Contribute to essential document development and regulatory filing preparation in collaboration with clinical development.

Requirements

• BS/BA - health/science related field preferred and a minimum 10-12 years relevant industry experience.
• Excellent organizational, communication, interpersonal, and decision-making skills.
• Demonstrated ability to work independently as well as in a team environment and seek resources as necessary.
• Ability to foster effective relationships with vendors, investigators and colleagues.
• Ability to contribute technical expertise to the various aspects of the clinical trial process.
• Proficiency in study monitoring activities.
• Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
• Demonstrated effective personnel management skills.
• Experience across Phase 1 through 3 clinical trial execution with a strong preference for first-in-human or early phase global experience.
• Dermatologic drug development experience is a plus.
• Must be willing to travel domestically and internationally up to 10-15%.

Benefits

• Competitive base salary and equity.
• Performance-related bonus opportunity.