Reporting to the Vice President of Clinical Development, the Senior Director Clinical Development is responsible for the design, planning, and medical oversight of clinical studies for all phases of development. The Senior Director, Clinical Development will collaborate with Clinical Operations for study implementation and serve as medical monitor. The Senior Director, Clinical Development will also oversee interpretation and dissemination of study results, including clinical study reports and related publications. The Senior Director of serve as a core member of the clinical development team, will contribute to devising of the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations.
Essential Duties and Responsibilities:
· Support the Vice President, Clinical Development in providing medical input into the design of the clinical development program, strategic and tactical plans for investigational products in all phases of development.
· Provides oversight and project management of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Avanir SOPs.
· Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs.
· Review clinical data from all phases of development and assist in generating study reports and publications.
· 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.
· Serve as study medical monitor, as needed.
· Support the Vice President Clinical Development with oversight and management of the department budget and financial planning.
· Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
· 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.
· MD degree with previous/current medical license required. Clinical experience in Neurology or Psychiatry required. Board certification preferred.
· 10 years of experience in the biotechnology / pharmaceutical industry with at least five years of hands-on clinical trials management and/or clinical development teams. Experience in CNS drug development required.
· 10+ years of experience leading, developing, mentoring and manage others required
· 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 across all phases of development including study design
· Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management
· Strong knowledge of FDA and ICH regulations
· Thorough knowledge of clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
· Expert knowledge of Good Clinical Practice (GCP)
· 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 25% of time
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.
Employer will assist with relocation costs.
Internal Number: R2022
About Avanir Pharmaceuticals
#AvanirPharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com#Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en