Celgene

NRDG Protocol Manager (PMS, ISR/IIT, PAA projects) (Contract until Dec. 2022)

Posted on: 6 Apr 2021

Plainsboro, NJ

Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

NRDG Protocol Manager (PMS, ISR/IIT, PAA projects) (Contract until Dec. 2022)

Division

* Regional Clinical Operations (RCO) Korea

Functional Area Description

* Provide end-to-end management of Non-Registrational Data Generation (NRDG) clinical research, crossing all therapeutic areas and research phases, collaborate with cross-functional teams to drive operational aspects of complex, Non-Registrational Data Generation (NRDG) clinical research including Investigator-Sponsored Research (ISR), Expanded Access Programs (EAP), Post Marketing Surveillance (rPMS) and some local late-stage interventional research

Position Summary

* Manages protocols within a complex matrix environment for successful and timely operational execution of clinical research from start to end
* Demonstrates flexibility and manages studies across organization (i.e. multiple TAs) & different study types (i.e. NIR, Late Phase, ISR)
* Focused on project management concepts to support management of issues, risks, timelines and budget.
* Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams

Position Responsibilities

* Monitor trial progress
* Address and manage obstacles
* Develop protocol-level documents and plans and training
* Identify issues and risks, escalating appropriately
* Select and oversee vendors
* Monitor study budget
* Manage and comply with various quality and compliance systems

Requirements

* Experience in execution of PMS projects
* At least 2-4 years of demonstrated project management experience of which at least 1 should have been in the pharmaceutical or healthcare industry.
* Experience in execution of clinical trials demonstrating project management and organizational skills.
* CRO experience is a plus.
* CTMS and electronic trial master file experience is a plus.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Celgene

Summit, NJ

Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.

The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.

The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.

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