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Director, Clinical Research

Avanir Pharmaceuticals

This is a Contract position in Aliso Viejo, CA posted June 12, 2019.

Director, Clinical ResearchThe Director of Clinical Research will participate in the oversight and management of Avanir clinical studies, including coordination with other relevant parties and developing the strategic approach to successfully conduct clinical studies being sponsored by Avanir Pharmaceuticals.The Director will ensure efficient execution of trials within established timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA, and ICH regulations, guidelines etc.

S/he will coordinate the efforts of internal and external resources to ensure timely patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality .

The Director of Clinical Research must possess excellent management and mentoring skills.Essential Job Functions:Participates in clinical research operations including initiation of clinical trials to optimize tactical and clinical value through global site selection and data portabilityProvides oversight and project management of clinical studies at Avanir, including planning, execution, and completion of clinical trials according 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 documentsWork with trial sites to ensure expedient patient recruitment in conjunction with CROWork with clinical operations team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPsWork with Clinical Development to draft/provide input on study protocols, conduct ongoing review of data and be able to interpret the data for final reportsManage, 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 accomplishedProvide management personnel with timely updates on progress and changes in scope, schedule, and resources as requiredManage study budgets and be able to provide accurate forecastingDevelop and implement SOPs for clinical trials and related activities, as requiredEnsure compliance with all applicable regulatory standards related to global clinical trials and interactions with physiciansDevelop and maintain professional relationships with academic and community-based study sitesInterface with departments within and outside of R&D including Finance, Regulatory Affairs, Legal Affairs and Medical AffairsManage staff and outside partners/service providersAbility to multi-task and manage several projects in parallel, paying attention to detailAbility to forge cross-functional working relationships with internal teams and external project partnersAbility to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashionAbility to travel up to 30% of timeOther duties, responsibilities and activities may change or be assigned at any time with or without noticeEducation/Qualifications:Bachelor’s Degree required15 years related experience in the biotechnology / pharmaceutical industry, including 8 yrs.

management expStrong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problemsExperience with all aspects of management of clinical trials from inception to completionStrong knowledge of FDA and ICH regulationsPrevious clinical trial site management experienceStrong MS Office skillsUnderstanding of statistics and statistical methodsKnowledge of Good Clinical Practice (CGP)Physical Requirements: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.Work Environment: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.EEO Statement: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.Avanir Pharmaceuticals, 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.comAvanir 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® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc.

in the United States and other countries