Celgene Principal Scientist, Translational Scientific Writer (Multiple Myeloma) in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.
Celgene R&D is at a critical and exciting phase of development. As it expands and integrates its portfolio, there is an opportunity for a dynamic and resourceful individual to lead our efforts in Translational Development at our site in Summit NJ.
Translational Development at Celgene:
Translational Development is part of the Global Research and Early Development organization in Celgene and leads early stage clinical, pharmacological and translational research and development activities for the pipeline and supports late stage portfolio for regulatory, translational development and life cycle management. Translational Development is in the process of organizing a late translational group to support multiple disease areas of interest including Myeloma, Lymphoma, CLL and other hematological malignancies. This group will integrate scientific and business insights of multiple functions and lead the development of translational strategies at the franchise level and implement them in project teams to maximize the potential of Celgene drugs.
Reporting to an Associate Director Translational Development, the incumbent will be part of the late translational group based in Summit NJ and will help develop translational strategies in multiple myeloma (MM) for approval or life-cycle management. Key responsibilities of this role are to act as key translational scientist to assist in developing translational strategy in MM by working with translational scientists and cross-functional disease teams and thematic centers of excellence, support regulatory strategy, and assist with development and execution of communication strategy (publication, slides, reports etc).
Background in cancer biology or immunology, with understanding of MM or related hematological malignancies preferred
Knowledge of the clinical landscape, evolving therapy, competitive scenario is desirable
Basic understanding of late-stage drug and translational development
Strong verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, mechanism slides, regulatory submissions, strategic communications, literature/market/pt segment analyses
Proven scientific/project leadership expertise (working in teams, managing people/projects)
Ability to synthesize complex scientific and business problems into strategy and tactics
Ability to tailor communication to different audiences (scientists, clinicians, cross-functional teams) and in different mediums (written documents, slides)
Ability to independently research scientific questions in the literature, summarize relevant findings, and draw hypotheses or conclusions based on available data
Experience in writing or developing disease and/or brand planning strategies, regulatory documents for in-line and late-stage development compounds in disease areas, preferably in MM, is ideal, but not required
Ability to learn and follow Celgene guidelines and processes (eg, Celgene Style Guide) for technical documents as well as appropriate regulatory style (ie, for responses to US and EU regulators)
Supports regulatory submissions in conjunction with other TD scientists including regulatory interactions, writes translational sections for regulatory responses and answers to regulatory queries for the TD group
Writes scientific / technical reports for non-GLP translational biomarker/correlative studies conducted by or on behalf of Celgene
Works independently and with other relevant line functions to prepare/review scientific summaries and regulatory documents and submissions, including: nonclinical summaries for IND, NDA, and CTD applications to Health Authorities, white papers, Investigator Brochures, product monographs/package inserts, and responses to health authorities.
Authors TD publications (abstracts, posters, manuscripts, presentations) in conjunction with other TD scientists for internal and external meetings and congresses
Reviews data to determine the appropriate tabular and textual formats, and clarity, logic and order of presentation.
Be an expert user of the templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
Contribute to the authoring, review, and approval process for documents within an electronic publishing system in conjunction with NWD Document Specialists and Regulatory Operations departments
Assists with organization, development, and tracking of disease specific translational annual goals and objectives for the late group (for internal /external, - translational collaboration, compound specific plans etc)
Represents Translational Development in cross-functional strategy teams as needed
Interfaces with Drug Safety to provide scientific support that aligns with TD, brand, and disease strategy for post-marketing safety requests and other queries related to approved and in-line products. This includes researching, writing, and presenting data within TD and to cross-functional teams, as needed
Communicates regularly and prepares and makes presentations within the department and externally as required
Participates in translational research in the Summit lab of Celgene
Requirements & Education:
PhD in life sciences or medical sciences, and a minimum of 8 years of directly relevant biotechnology or pharmaceutical industry experience. Candidate must be detail-oriented with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic environment.
Strong background in cancer biology, especially hematological cancers
Ability to work with multiple complex projects and within cross-functional teams
Demonstrate in-depth, scientific-directed, innovative thinking
Excellent technical scientific writing and verbal communication skills required
Experience as a nonclinical toxicology, pharmacokinetics, and/or pharmacology writer that included contributions to Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD) for FDA and worldwide regulatory documents is preferred
Proficiency in use of Microsoft Word, Excel, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process
Effective team building and teamwork skills with multiple functions
Detail-oriented with the ability to identify and implement creative solutions
Ability to prioritize and manage time efficiently
Some experience with supervision and mentoring of scientific staff is desirable
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Principal Scientist, Translational Scientific Writer (Multiple Myeloma)
Location: Summit, NJ, US
Job ID: 17001006