Clinical Supply Lead

Clinical Supply Lead

The Clinical Supply Lead is responsible for translating clinical protocols into actionable supply plans and managing the on-time & on-budget delivery of global clinical supplies projects across the Menarini Stemline portfolio. Work closely with Clinical Operations / Development / Medical Affairs colleagues to develop and modify study supply & resupply plans. Prepare material forecasts at study and program levels. Track material use and expiry dating to ensure uninterrupted delivery of clinical study supplies, including contingency plans. Actively communicate supply plan progress to all stakeholders. Build and maintain positive working relationships ("partner mindset") with co-workers, functional areas and vendors to accomplish project objectives. Responsible for input into bulk drug forecasts using enrollment & portfolio updates from Clinical Operations / Medical Affairs. Ensure CMC / Manufacturing have current drug demand forecast over a 2-year horizon. Vendor Management-prioritize packaging activities at Contract Manufacturing Organizations (CMO). Serve as Person in Plant (PIP) as required when packaging operations for Menarini Stemline are in-process. Maintain Ancillary and Drug Wholesaler relationships, where required. Provide supply related input / testing for Interactive Response Technology (IRT). Including specification review and approval. Responsible for coordinating and development of clinical label text, associated country-specific label text and proofs in partnership with Clinical Operations / Medical Affairs, Regulatory, and Quality Assurance and CRO's, where applicable. Provide clinical site support with timely and accurate resolution of Temperature Excursions (TEs), Product Complaints, SIV and clinical supplies-related training (if necessary), and Investigator Mtg's (as required). Meet all department, divisional, and corporate training requirements. Being a positive contributor and collaborative member of the clinical supply team. Assist in the creation and review of SOP's and work instructions as requested. Assist in vendor invoice review and corresponding SAP transactions. Monitor the effectiveness of processes and quality of project work. Anticipate project needs and continually search for ways to improve project delivery. Travel up to 25% is possible.

Qualifications : BA / BS in a related field required. At least 7+ years of industry experience managing complex clinical trials, project management and / or in a clinical supplies capacity. Experience in a GMP environment at a pharmaceutical, biotechnology company or CMO. Oncology experience preferred. Proven experience managing complex and international clinical trial supply chains. Experience managing multiple vendors required. MS Office proficiency required. SAP and Smartsheet experience preferred. Expertise in clinical supply forecasting. Knowledgeable in Regulatory agency guidelines such as FDA, ICH, etc., as related to clinical supply activities. Ability to work independently and in cross-functional team environment. Ability to manage multiple priorities and operate effectively. Ability to work in a global environment with primary communications between Europe and the US and at times with Asia Pacific and Latin American regions. Strong technical writing and communication skills. Ability to work effectively across the company with exceptional interpersonal skills. Ability to travel both domestically and internationally, as needed. Base Salary Range of $150,000-$180,000 annually. Menarini Stemline offers generous compensation and benefits packages, including Short-Term Incentive, Fidelity 401(k) (with 6% company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA / HSA programs. Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Minimum Salary : 150000 Maximum Salary : 180000 Salary Unit : Yearly