Director, Clinical Operations

MESO SCALE DIAGNOSTICS, LLC.•Rockville, MD

7h•Onsite

About The Position

This director level position oversees and is responsible for all aspects of clinical development, including clinical research, operations, safety, and portfolio planning. The Director oversees vendor relationships, site selection and management, and contract and budget negotiations. This position will serve as a member of the Clinical Therapeutics leadership team and will provide input in developing the department’s overall strategies, budgets and plans.

Requirements

Bachelor’s degree or higher in Science or Business
Minimum of 12 years of experience in clinical operations, vendor selection and management, budget and contract management
Minimum 6 years of direct or indirect supervisory experience (e.g., managing cross-functional teams)
Experience in life sciences, GXP, government contracting or other regulated industry desired
Experience with submissions of Investigational New Drug (IND) applications and New Drug Applications (NDA)
Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem-solving.
Ability to work effectively in a fast-paced, high-energy, demanding and deadline driven environment.
Strong leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
Ability to provide day to day guidance/mentoring to others in a consistently supportive and collaborative approach.
Ability to build/foster relationships by reinforcing trust and respect, and demonstrating high standards of tact, diplomacy and discretion.
Excellent oral and written communication and interpersonal skills and ability to work well with personnel at all levels.
Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data.
Effectively communicate performance goals and expectations to staff.
Proficiency in MSD Office Suite; MS Project experience.

Nice To Haves

At least 4 years of experience in a services organization and preferably at a Pharmaceutical or Biotechnology Company or contract research organization

Responsibilities

Supervise and manage the internal clinical team
Participate in designing and writing clinical trial protocols
Manage clinical site selection, trial agreements, and budget negotiations
Selection and management of vendors required for the conduct of clinical trials (e.g., Clinical Research Organizations, central labs, central Institutional Review Boards, analytical labs, etc.)
Negotiate vendor contracts and budgets throughout the lifecycle of clinical trials
Conduct investigational product forecasting and management
Design, review and approve ancillary forms
Review and approve clinical study documents including SAP, EDC design, validation specs, edit specs, annotated CRFs, shell and final tables, figures and listings, clinical study reports, etc.
Collaborate with Executive Director, Clinical Therapeutics regarding IP formulation, manufacturing schedule, stability programs, etc.
Provide Investigational Brochure input
Manage relevant aspects of compassionate use program
Performs other duties as assigned