Manager of Investigational Product and Clinical Supply
Proclinical is currently recruiting for a Manager of Investigational Product and Clinical Research with a global pharmaceutical company located in New Jersey. Successful candidate will be responsible for forecasting IP supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials, and performing activities on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations/guidelines and applicable SOPs.
- Contribute to ongoing process improvement initiatives.
- collaborate and interact with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability). This role applies to internally sourced studies and/or CRO/Partnered studies. Key Responsibilities.
- Serve as lead logistics manager for the functional area in supply planning, including demand forecasting according to IOPS requirements.
- Manage supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.
- Work with clinical logistics management to determine resourcing needs.
- Provide input to the development of IP-related study documents including protocols, study and pharmacy manuals.
- Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines.
- Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
- Lead management of IP service vendors (performance, quality, timelines, deliverables, and costs).
Skills and Requirements:
- Bachelor's degree and at least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years of work experience in clinical supply management.
- Experience in ophthalmology clinical development is strongly preferred.
- Experience in developing trial drug supply plans.
- Working knowledge of clinical drug development process and clinical trial methodology.
- Investigational Product forecasting skills.
- Ability to effectively multi-task and prioritize.
- Project management and organizational skills.
- Computer skills with competency in Microsoft Word and Excel.
- Study Tools including electronic system skills, IVRS/ IWRS, CTMS and EDC.
- Cross-functional and cross-cultural awareness.
- Excellent verbal, written, and interpersonal skills, and ability to influence a small team of functional experts.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Phil Sawyer at (+1) 617-545-5923 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.