Director, Clinical Study Management
Essential Job Functions:
- Participates in clinical study management including initiation of clinical trials to optimize tactical and clinical value through global site selection and data portability.
- Provides oversight and project management of clinical studies at Avanir, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Avanir SOPs.
- Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.
- Work with trial sites to ensure expedient patient recruitment in conjunction with CRO.
- Work with clinical operations team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs.
- Work with Clinical Development to draft/provide input on study protocols, conduct ongoing review of data and be able to interpret the data for final reports.
- Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Avanir departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
- Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
- Manage study budgets and be able to provide accurate forecasting.
- Develop and implement SOPs for clinical trials and related activities, as required.
- Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
- Develop and maintain professional relationships with academic and community-based study sites.
- Interface with departments within and outside of R&D including Finance, Regulatory Affairs, Legal Affairs and Medical Affairs
- Manage staff and outside partners/service providers.
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to forge cross-functional working relationships with internal teams and external project partners.
- Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion.
- Ability to travel up to 30% of time.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
- Bachelor’s Degree required.
- 14+ years related experience in the biotechnology / pharmaceutical industry, including 8+ yrs. management experience.
- Strong project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Experience with all aspects of management of clinical trials from inception to completion.
- Strong knowledge of FDA and ICH regulations.
- Previous clinical trial site management experience.
- Understanding of statistics and statistical methods.
- Knowledge of Good Clinical Practice (GCP).
- Strong proficiency in MS Office (e.g., Outlook, Word, Excel, PowerPoint, Visio, etc.)
This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.
As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.
Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.