Sr. Director, Clinical Operations - United States
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- The Sr. Director of Clinical Operations will be responsible to oversee the implementation and management of early and late phase clinical studies.
- This position will partner with clinical development scientists and other development team members, contract research organizations, and consultants to ensure the successful, cost-effective, and timely execution of early 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.
- In addition, the Senior Director may act as the Operational Team Leader for co-ordination and management of a program of clinical trials, and participate in the Clinical Development Team meetings to provide expertise in clinical operations.
- The Senior Director may also be required to be the Study Team Leader for large complex studies, and mentor more junior members of the clinical operations team.
To perform this job successfully an individual must be able to perform each essential function 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.
- Works with the project management to identify project objectives, identify potential obstacles and propose innovative solutions, and ensure adequate resources are implemented to ensure successful completion of the project.
- Works with Regulatory Affairs to manage communication with pharmacovigilance
- contract organization
- Manages external resources such as consultants or paid advisors
- Coordinates vendor meetings and review vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy.
- Will develop Project Plans to include timelines and milestones.
- Prepares Clinical documents (e.g., 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:
- Regulatory interactions and documents
- Safety interactions and documents
- Will communicate directly with senior management regarding progress of the project.
- May have supervision of direct subordinates
- Understanding of working in a Matrix
- Has strong global clinical operations experience
- May manage staff work and resource allocation
- Other duties and responsibilities as assigned
- BS, BA, RN, and 20 years in Clinical Research, or MS, PharmD degree and 15 years of Clinical Research experience, or PhD, MD and 10 years in the Clinical Research preferably in the biotechnology / pharmaceutical industry
- Minimum of 10 yrs experience in Clinical Operations roles with more than 4 years as Director or above
- 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 processes 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 organization
- Knowledge of GCPs, 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.
- Must be prepared to act in Clinical ‘research’ as well as ‘operational’ roles.