at Terumo BCT
Posted on Aug. 2, 2017
Director - Global Clinical Affairs
Directs Clinical Affairs responsibilities for all Product Development (PD) projects. Develops objectives, plans, and protocols for clinical trials to achieve end results that support the organization's business strategies and goals. Overall responsibility to conduct, coordinate and manage clinical trials, clinical studies, national validation studies, post market surveillance, and hemovigilance studies. Manages the Clinical Advisory Board (CAB) for the organization. Reports to the VP of Scientific and Clinical Affairs.
DUTIES AND RESPONSIBILITIES
Director - Global Clinical Affairs
- Participates in development of clinical strategy. Responsible for execution and implementation of clinical strategy. This includes supervising clinical staff, building relationships with principal investigators, and managing relationships with vendors responsible for execution of all clinical activities.
- Accountable for all global clinical trials.
- Responsible for adherence of all clinical study programs to international standards including ICH, CFR and ISO guidelines and requirements.
- Responsible for establishing consistent processes to be used in the conduct of clinical studies by Terumo BCT in all geographic locations and in accordance with standardized set of operating procedures in all geographies.
- Responsible for oversight of staff activities in various geographic locations related to clinical trial activities and management.
- Advises executive team on clinical and limited regulatory matters.
- Ensures that proposals for clinical studies meet regulatory requirements, corporate objectives, and company SOPs. Develops recommendations to the Executive Management Team concerning whether proposal should be approved or not.
- Directs activities relating to negotiating clinical research organization agreements, investigator agreements and clinical site selection.
- Responsible for resolution of customer complaints related to Clinical performance; determines action needs of MDRs and report as necessary. Responsible for preparation of Clinical evaluation reports.
- Ensures preparation of pre-market submission of packages such as PMA's to regulatory authorities.
- Responsible for developing, monitoring, and reporting metrics designed to improve and assess trial performance, including speed and effectiveness of site start-up, training, speed and accuracy of screening, recruitment, protocol adherence, data collection and reporting.
- Leads all business area Clinical Advisory Boards and the company's Clinical Advisory Board. Responsible for bringing in subject matter experts as needed.
- Ensures that all clinical site and field teams are reporting serious adverse events and apply clinical knowledge to assist investigators in resolving adverse events.
- Selects, develops, manages, mentors, and evaluates clinical personnel (including consultants and independent contractors) to ensure the efficient operation of clinical research.
- Ensures a close alliance with the Regulatory Affairs department to implement protocols and support regulatory submissions.
- Ensures a close alliance with the Research and Development department to identify the desirability of and support for the development of technology advances.
- Ensures a close alliance with the Marketing department to develop initiatives and materials to improve clinical trial conduct and support commercial activities including development of educational materials designed to inform key constituencies at sites - investigators, coordinators, referring physicians, and other clinicians and patients.
- Responsible for ensuring clinical requests and feedback are understood by all other departments company-wide.
- Leads external groups participating in clinical trials, including clinical research organization, principal investigator groups, and data safety monitoring boards.
- Responsible for working with the scientific and marketing functions to develop design of pre-clinical and clinical studies of new products and protocols to support product claims and regulatory submissions.
- Accountable for planning, coordinating, monitoring and reporting on clinical studies conducted for the business. Responsible for identification of appropriate resource requirement and their qualifications.
- Ensures adherence to protocols and company general policies regarding clinical studies.
- Establishes study/trial priorities.
- Maintains state-of-the-art knowledge of the requirements for proper conduct of clinical studies/trials and the requirements of both regulatory and internal for international and domestic applications.
- Accountable for updated departmental procedures as they relate to clinical trials, etc. based on any changes in regulatory requirements or company policies.
- Prepares reports/documentation for regulatory submissions derived from studies managed.
- Reviews study reports to determine that study/trial objectives are met and that the results are valid from a clinical perspective.
- Advises Executive Management Team of results, as well as any observations that may be of a clinical or product performance importance.
- Ensures a broad base of knowledge and understanding of regulatory requirements.
- Identifies areas where the business can affect improvements and establishes operating policies with direction.
- Responsible for developing, preparing, gaining approval, and executing department budget.
MINIMUM QUALIFICATION REQUIREMENTS
- Advanced degree (PhD, MD) in medicine, nursing, biological sciences, or in related scientific or medical discipline is required.
- 10 years' experience required conducting clinical trials in the medical device field.
- Minimum of 5 years' prior experience at a Director level position in Clinical Affairs or related field in an organization of the size of Terumo BCT
- Extensive experience in managing all phases of multi-center clinical trials for medical devices, diagnostics, or pharmaceuticals.
- International clinical trial experience required.
- Extensive knowledge and understanding of clinical trial reporting requirements and regulatory requirements.
- Thorough knowledge of the physiology and clinical practice of the relevant therapies.
- Knowledge of medical statistics and experimental design.
- Broad knowledge of clinical methods, both laboratory and therapy delivery related.
- Extensive knowledge of clinical study (GCP) and good working knowledge of regulatory requirements.
- In-depth technical knowledge of international medical device regulations, standards, policies, and guidance documents.
- Demonstrated ability to effectively direct and lead clinical trial team activities on a global basis and achieve results through others.
- Working knowledge of and ability to prepare regulatory documentation.
- Demonstrated effective leadership, managerial, and strategic planning skills.
- Demonstrated ability to interpret regulations and apply sound business judgment.
- Demonstrated ability to solve practical problems and interpret and communicate complex clinical requirements.
- Demonstrated ability to interact productively and cross-functionally to effectively influence team, peers, colleagues, and senior management.
- Ability to establish effective working relationships with all levels of clinical/technical/marketing individuals in corporate, clinical, and academic settings.
- Industry experience in representing the business during early collaboration meetings with regulatory authorities and conferring with those regulatory authorities regarding pending and proposed submissions.
- Advanced understanding of support processes and metrics.
- Demonstrated self-direction, initiative, and ability to work independently.
- Demonstrated positive and proactive approach to identification and definition of problems and the development and implementation of solutions.
- Demonstrated interpersonal skills and ability to represent the business with both those who are internal and external to the organization.
- Demonstrated ability to select, manage, motivate, educate, and evaluate others.
- Exceptional expertise in planning, budgeting, personnel development, and project management directed at achievement of short and long-term business goals.
- Requires an in-depth knowledge of details, processes, and reporting to ensure team members are focused on tasks at hand and management is informed of opportunities, challenges, and obstacles.
- Exemplary interpersonal and conflict resolution skills.
- Advanced capability to effectively communicate and interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
- Advanced presentation and communication skills, especially the ability to frame complex clinical issues in an easy-to-understand manner.
- Proficient computer and organizational skills.
- U.S. and international travel will be required at 25% - 30% (periodically 50%).
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers .