Director Clinical Operations

Director or Associate Director, Clinical Operations (DOE)

The Director (or The Associate Director- DOE) of Clinical Operations is responsible for managing clinical operations activities at the project level including coordination of clinical trial activities, directing and supporting the clinical operations staff, working with study specific vendors, and collaborating with cross-functional product development team members. Additionally, the AD/Director will ensure project activities are completed on-time and within budget while adhering to all quality and regulatory standards. We are located in Waltham, MA but only come into the office 2x a week- we are looking for other strong, responsible leaders to join us. (We will also relocate anyone thinking of moving here)!

Responsibilities

• Provide leadership and expert oversight of clinical studies including project planning, budget, resource management and contract research organization negotiation and management


• Contributes to clinical development plans and ensures alignment to business and regulatory strategies


• Act as a cross-functional liaison between clinical operations and product development teams and ensures effective alignment regarding plans, requirements, and deliverables


• Manages all aspects of study progress from start-up to close-out activities adhering to intended timelines to achieve study goals while ensuring compliance with ICH/GCP, MDR and ISO-14155 guidelines, regulatory requirements, and SOPs


• Oversees and manages CROs, vendors, and internal staff to ensure successful conduct of the clinical trial including being the point of contact for issue escalation and resolution


• Contributes to individual and team development through training initiatives, team building activities and mentoring and training of junior staff members


• Writes and/or reviews Standard Operating Procedures (SOPs) for the Clinical Operations Department including study or site related documentation


• Promotes and develops corporate initiatives for the Clinical Operations Department

Requirements

• Minimum RN or Bachelors degree in a scientific discipline


• Proven track record in managing clinical operations activities and staff


• 8+ years of experience leading multiple global cross-functional clinical studies (Phases 1 -2, Phase 3 preferred) and vendors. Therapeutic medical device early development experience highly desired.


• Respiratory and/or cardiovascular experience preferred


• An understanding of and experience in the drug and medical device development process is required including: clinical program management, drug safety surveillance and reporting requirements, global regulatory reporting requirements, clinical study report requirements.


• Working knowledge of ICH/GCP, ISO-14155, FDA, MDR, and EU Regulations, as applicable


• Excellent team player with a proven track record in establishing working relationships with individuals from a broad range of backgrounds on cross-functional teams


• Proven track record in managing, motivating and engaging with clinical staff


• Advanced knowledge of the principles of project management, statistical data analysis and interpretation


• Able to distill complex information from multiple sources and draw meaningful conclusions and insights


• Represent the company with a high level of integrity and professionalism


• High level of initiative and ability to work independently; self-motivated and achievement driven.


• Ability to handle and prioritize multiple assignments in a fast-paced environment with changing priorities and meet deadlines and milestones


• Strong verbal and written communication skills and adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with cross-functional teams, stake holders and external vendors.


• Extensive computer skills and use of Microsoft Office applications, including proficiency in MS Project. Requires strong word processing skills.


• Ability to travel (domestically and internationally) up to 25%