Regulatory Affairs/Clinical Affairs • Allegan, Michigan | Bronx, New York | Charlottesville, Virgina
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
The Associate Director, Clinical Affairs is:
- Responsible for the leadership and oversight of clinical study or program operations by organizing and coordinating the planning, implementation, management, execution and completion of clinical programs according to applicable regulations and guidance, ICH and GCP, and Perrigo Research & Development operating procedures.
- Also responsible for the development of clinical systems/processes and effective communication within and outside the corporation related to the implementation of processes and successful completion of studies.
- Manage the development process for clinical systems and critical study documents (e.g., protocol, amendments, IB, ICF, CRFs, DMP, SAP, drug supplies, etc.).
- Coordinates the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS, etc.).
- Manage the identification, evaluation, and selection of investigators/sites and internal and/or external resources.
- Ensure study supply requirements are met.
- Ensure appropriate communication with and maintenance of clinical study sites including training of site personnel in the study protocol and other study-specific procedures.
- Communicate with relevant global R&D team members and external consultants to ensure study objectives are met and provide timely updates on progress, changes in scope, schedule, and resources.
- Organize investigator and expert meetings relevant to the indication and assist with the organization and management of Data Review Committees and KOLs.
- Prepare study timelines, budgets, and budget forecasting materials for leadership and ensure study execution is aligned.
- Oversee the monitoring, reporting of adverse events, and development of study reports
- Attend related courses, seminars and necessary training in accordance with individual development plan and needs of the organization.
- Read professional journals and publications to stay abreast of current scientific knowledge in particular therapeutic area as well as in applicable guidelines and regulations.
- Obtain information from the field on relevant new scientific developments and share learnings with appropriate departmental, project, or study team members.
- Strong knowledge of Good Clinical Practices (GCP), clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management.
- Minimum 8 - 10 years' experience in the industry with approximately 6 - 8 years managing clinical trials.
- 3 - 4 years' experience in managing and training clinical personnel (Managers, Sr. CRAs, CRAs, project assistants).
- Strong planning and organizational skills with ability to multi-task and plan activities as it relates to management of clinical trials.
- Experience leading and working within cross-functional teams and managing external service providers.
- Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, outside vendors, consultants, team members and various audiences.
- Ability to problem solve, build teams, and to lead and motivate others.
- Effectively work independently as well as within a team matrix.
- Financial management skills as applicable to overseeing project expenditures and budget forecasts.
- Advanced computer skills (Microsoft applications, etc.)
- Willing and able to travel.
We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.
Due to the highly regulated pharmaceutical industry and legal requirements, you may be subject to post employment background checks.
Equal Employment Opportunity/M/F/disability/protected veteran status.