The Director of Clinical Operations will, in partnership with senior management, implement and manage early and late phase human clinical studies to achieve the project and corporate objectives. This position will workwith other development team members, clinical research organizations, and consultants to ensure the successful, cost-effective, and timely execution of clinical studies (including proof-of-concept study). Responsibilities will also include managing across clinical sites in coordination with CROs, tracking and ensuring projected enrollment, and coordinating sample analyses and data management activities. It is expected that he/she will manage the conduct of clinical trials that meet the business and product development goals of the Company.
To perform this job successfully an individual must be able to perform each essential functions satisfactorily.
• Oversees and manages clinical team in U.S. and Europe (other worldwide, as necessary) to ensure alignment of activities with study/project timelines and to provide overall oversight of activities requiring GCP compliance.
• Identify project objectives, identify potential obstacles and propose innovative solutions, and ensure adequate resources are implemented to ensure successful completion of the project.
• Manages external resources such as consultants, contractors, CRO’s.
• Coordinates vendor meetings and review vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy.
• Develops Project Plans to include timelines and milestones.
• Prepares Clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures, guidelines, and departmental policies.
• May identify and assist in departmental training requirements including internal and external operations.
• Will provide clinical content input to:
o Regulatory interactions and documents
o Safety interactions and documents
• Will communicate directly with senior management regarding progress of the project.
• Supervise direct reports and matrixed study team.
• Other duties and responsibilities as assigned
• Knowledge of GCP, ICH guidelines and FDA regulations. Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus.
• Understanding of the principles of project management and proven ability to lead a project team.
• Prior experience with managing large multi-center studies with a keen understanding of all aspects of Clinical Operations, including: clinical trial design, study implementation/start-up activities, CRA and site management, data management (to database lock and data analyses).
• Must possess a professional demeanor and effective communication capabilities for collaboration with others in a multi-disciplinary group.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables.
• Adaptable and able to work in a work environment where priorities are constantly changing.
• Ability to effectively present ideas and document concepts in writing and orally.
• Excellent computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
• Ability to travel, in some cases, internationally (Average travel expectations: <20%/year).
• Should have both interest and experience in medical writing (e.g. protocols, study reports) and in analyzing data during and after the conclusion of studies.
BS, RN, MS or PharmD degree plus at 12 years of experience in biotechnology or pharmaceutical industry
• 10 years experience in Clinical Operations roles with minimum 2 years as a
senior manager or above in a biotechnology or pharmaceutical company with direct involvement in early phase human clinical trials
• In-depth experience soliciting CRO and key vendor proposals, critically evaluating
competing proposals, negotiating key terms, and selecting/initiating these relationships
• In-depth experience with drug development issues is required
• Experience interacting directly with clinical sites is required
• Experience in review or writing of clinical protocols, study manuals, case report forms,
and informed consent forms is required
• Ability to present technical and business aspects of projects
• Forward-thinking and creative with high ethical standards
• Team player with leadership skills
• Able to work in a fast paced environment with drug development professionals
• Well organized and self-directed
• Strong interpersonal skills with an ability to communicate to people at all levels of an