The Associate Director, IMP Management is responsible for the planning and management of investigational medicinal product for global clinical studies. Will interact with and support the global development teams to assure the availability of clinical trial materials for planned clinical studies. Interact with Shionogi affiliates to understand status of the manufacture, packaging, and labeling of Investigational Medicinal Product materials.
RESPONSIBILITIES
Interface with Clinical Development to assess and determine required quantities of materials, develops forecast supply models to address these needs, develop clinical supply plans, packaging configurations and distribution strategies.
Influence teams and develop / lead initiatives with strategic clinical supply insight and focus.
Work with Clinical Trial Managers, CMC Teams, Regulatory Affairs and Quality Assurance to provide input to the design of appropriate labeling, packaging, and shipping configurations. Interface with relevant internal (SI) departments to communicate CMC progress to deliver the required materials.
Contribute to and support clinical team’s selection of study-related vendors for distribution.
Establish drug supply chain standardization specifications across all clinical trials including the establishment of specifications for blinded clinical trials involving the use of Interactive Response Technology (IRT).
Responsible for helping with set-up of all third-party vendor specifications (i.e. IRT) for distribution and reconciliation of clinical trial materials.
Responsible for on-time distribution of clinical drug supply to US and worldwide clinical sites.
Responsible for assuring accurate drug accountability/reconciliation for investigational medicinal product (IMP) issued during the study to the site and at the end of the study.
Responsible for relationship management with key stakeholders in support of all ongoing and planned GDO and SI lead clinical trials (Phase I-IV) in US by interfacing with functions that manage IMP including manufacturing, packaging, and labeling.
Provide supply forecasts and requirements to the CMC team to ensure appropriate delivery schedules of drug product for clinical use.
In conjunction with CMC, responsible for assuring sufficient clinical drug supply is packaged, available and shipped to sites for study start up; and that sufficient supplies are maintained during the study.
Interface with CMC functions to ensure documents and supplies meet study and regulatory requirements.
Create options and strategies to meet needs and/or schedules as they evolve.
Assist Clinical Operations as needed in distribution, handling complaints, returns and destruction of drug supply.
Lead global IMP process updates and SOP or Work Aids creation or revisions.
Attend weekly early morning (6 am) meetings as scheduled to interact with global partners.
Work with Director of IMP Management to create dashboards/reports to communicate program progress and milestones for commercial and development products.
Potential job growth could include managing direct reports.
REQUIREMENTS
BA/BS in life sciences or equivalent; Advanced Degree or certification preferred.
Minimum of 8 years of experience with drug supply management derived from direct pharma industry or vendor experience.
Clinical Operations experience and / or demonstrated expertise in oversight of CRO relationships and activities.
Significant knowledge of pharmaceutical industry, drug development and regulatory processes to maintain compliance with all applicable regulatory guidelines, GXP and company SOPs and policies.
Knowledge of GMP, GLP, GCP and GDP compliance requirements.
Demonstrate ability to resolve complex problems and lead multiple projects of diverse scope; analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior management.
Solid knowledge of and comfort working with Interactive Response Technology (IRT).
Strong collaborative skills with demonstrated ability to effectively work with clinical trial staff.
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 is preferred.
Ability to work with successfully with minimal supervision, and comfortably within a fast-paced and dynamic work environment; able to embrace change.
Ability to work cross-culturally, to lead by example in establishing a close partnership and to maintain flexibility in a cross-cultural environment.
Demonstrate strong working knowledge of supply chain management of clinical supplies including international packaging regulations, import / export licensure and drug depot utilization.
Demonstrate knowledge of labeling, packaging, inventory management and distribution procedures related to clinical supplies.
An understanding of formulation / drug product process development and scale-up; packaging, technology transfer; cGMPs, ICH guidelines; as well as CMC content of regulatory submissions is a plus.
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines.
Proficient computer skills and knowledge of standard office software including WORD, EXCEL and VEEVA Systems.
Ability to travel 10%-15% including possible international travel.
Small company experience is beneficial.
Flexible work arrangements will allow for work from home, but we recommend you live a commutable distance to our offices in Florham Park, NJ to allow for your convenience on days when you do need and/or want to work onsite.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
EEO
Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities 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)
