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 such as pain, women's health and anti-infectives. 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.

The Associate Director Clinical Development / Operations -(Team Leader) will 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.

DUTIES AND RESPONSIBILITIES

• Manage indirect and 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 to management for resource requirements (time, financial, manpower) within Clinical Development within agreed upon parameters.
• Participate in preparing 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.

Specific Duties:

• Will be accountable for working closely with the CRO (when appropriate) to oversee clinical activities, data management and bio-statistical analyses and oversee adherence to study timelines. Collaborate with SI Biometrics and Pharmacovigilance in directing the following areas: query resolution, logic edit checks, QA/QC of adverse events, serious adverse event processing and SIOMs.
• Accountable for assuring accurate drug accountability/reconciliation for IP issued during the study and returned at end of study.
• Accountable for vendor deliverables.
• Will oversee study level budget, and for monitoring invoice payments for CROs, travel, contracts, clinical trial agreements, etc.
• Will manage relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File.
• Responsible for collecting, preparing and reviewing regulatory documentation for IRB/EC submission prior to study start-up.
• Responsible for planning, participating and presenting at Investigator Meetings.
• Will be accountable for assuring sufficient clinical drug supply and required ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.).

Requirements

MINIMUM JOB REQUIREMENTS

• BA/BS in life sciences or equivalent; or RN/BSN; Advanced Degree or certification preferred.
• At least 8 years of clinical research experience including at least five (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.
• 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 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.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.

To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html -- and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
• Please view Equal Employment Opportunity Posters provided by OFCCP

. * The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)