Project Lead, Global Clinical Supply

Company: Genmab A/S
Location: Princeton
Posted on: February 24, 2021

Job Description:

The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com . Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.-- The Role
The Global Clinical Supplies Project Lead (PL) leads, represents, handles and supports CS project team and operates as single point of contact for clinical and technical teams across Genmab's Global Clinical Development Programs on global clinical supply strategies.

Responsibilities The PL ensures complete project oversight in CS and retains accountability for project results; has operational end to end responsibility for assigned activity; leads and handles all project and local network activities; and, participates in cross-functional teams. Represent team, in the Clinical Management Team meeting and act as business partner to support the decision making on the supply strategy and packaging design to be adopted in clinical trials Assess clinical development plan scenarios, converts them in demand forecast to support long term supply strategy in the project. As business partner to the clinical teams, drive clinical supplies assessment to support unplanned clinical study requirements. Leads overall global clinical supply strategy in projects and in alignment with clinical and technical requirements and constraints. Assess risks & opportunities and define strategies to ensure supply continuity and increase supply flexibility and responsiveness in case of new clinical study initiatives. In addition coordinates the entire supply strategy (from Drug Substance and comparators to clinical sites) and reviews the planning assumption adopted in the supply plans and forecasts. Participates in the decision making process in Clinical Supplies to select the most appropriate supply model. Operates as first level of partner concern and provide clear overview on issue, supply impact and mitigation plan to CS management in case of supply risk / issue. Leads communication and manages expectations in case of issue. Leads, represents, manages and supports CS sub-team in an indirect people management role. Assures CS team works in agreement to the operating model and delivers results in alignment to the clinical project/study objectives. Ensures goals are achieved and act as a role model for strong team spirit and behaviors of collaboration. Requirements Degree in pharmaceutical science, engineering or equivalent preferred 5 years of practical experience in pharmaceutical industry in a similar role or > 3 years of experience in drug supply of Oncology drugs and comparators Good expertise and understanding of global sourcing of comparators. Knowledge about the Drug Development process Good expertise in the IMP pack, label and distribution process Basic project management, good organization and planning skill s Expertise in GMP and GDP for IMP For US candidates, in case you have any questions, please feel free to reach out to Recruiter Rebecca Fine @ refi@genmab.com . For DK candidates, please feel free to reach out to Recruiter Jannie Jansen @ jjn@genmab.com Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc. Please note that if you are applying for a position in the Netherlands; Genmab's policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority. Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website-- https://www.genmab.com/privacy . Posted 19 Days Ago R1036 About Us Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of four approved antibodies. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies and intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Similar Jobs Follow Us Genmab A/S obtains personally identifiable information provided and used as per our Privacy Policies

Keywords: Genmab A/S, Trenton , Project Lead, Global Clinical Supply, Healthcare , Princeton, New Jersey