|Description: Shionogi Inc. is the U.S subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financial backing and the research capabilities of a well-established leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.
Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas of cardiovascular disease, diabetes, pediatric conditions, and womens health. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines essential to people's health for over 130 years.
We are seeking dynamic, focused and creative individuals to join our growing team. We are currently expanding our workforce in our New Jersey headquarters location and looking for experienced pharmaceutical professionals to help us build for the future.
SCOPE OF POSITION:
In general -- oversee and manage all operational aspects of phase I IV global clinical trials in order to achieve a high quality product for the marketplace and business success for Shionogi Inc. Specifically Responsible for phase II B trial currently enrolling patients via CRO. Study focus is opioid-induced GI effects. Additional studies planned.
May manage indirect reports and limited number of direct reports, external partners, consultants, vendors and external budget to ensure the timely and cost-effective implementation of clinical trials.
Supervise and mentor direct and indirect reports to assure performance and progress on assigned projects as appropriate.
Manage assessment of CROs and preferred vendors for implementation of clinical development plan. Review and approve contracts, work orders and invoices prior to submission to senior management for approval.
Establish and maintain effective communication and collaboration with functional area peers including Drug Safety, Quality Assurance and Regulatory Affairs, as well as thought leaders in order to meet program objectives and support achievement of goals.
Responsible for resource requirements (time, financial, manpower) within Clinical Research and management within agreed upon parameters.
Participate in preparing CDP (clinical development plan).
Responsible for completeness and accuracy of the study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure.
Responsible for leading protocol and study specific clinical and operational meetings.
Contribute to and support selection of all study-related vendors.
MINIMUM JOB REQUIREMENTS
BA/BS in life sciences or equivalent; or RN/BSN. Advanced Degree or certification preferred.
Minimum of 10 years of clinical research experience including at least 5 years with significant experience effectively leading projects from inception to completion coupled with demonstrated ability to hold team members accountable to tight timelines and budgets.
Experience with pain management compounds and side effects.
Demonstrated expertise in daily oversight of CRO relationships and activities and a track record for completing trials on time and within budget.
Significant knowledge of pharmaceutical business, drug development and regulatory processes.
Demonstrated ability to resolve complex problems and lead projects of diverse scope, analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior management.
Strong management and collaborative skills with demonstrated ability to effectively mentor study managers and clinical trial staff.
Ability to effectively work in a multicultural environment; and manage interactions with academic thought leaders ensuring cooperation for achieving program goals.
Proficient computer skills and knowledge of standard office software.
Ability to travel 10%-15% including possible international travel.
Strong written and verbal communication skills along with excellent interpersonal skills and proven ability to interface effectively with diverse development teams.
Strong presentation skills and the ability to present scientific information to varied audiences.
Our employees are considered the most valued part of our organization. We demonstrate this commitment to our employees by offering a competitive salary and a comprehensive employee benefits package.
To be considered for this position, you must apply online at www.shionogi-inc.com and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
Shionogi Inc. is an equal opportunity employer proud to support diversity in the workplace.
Shionogi Inc. does not accept unsolicited third party resumes.
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