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Assignment Brief for the position of Senior Scientist Computational Biology CITRE - Celgene Ref: PSL2020 Prepared by: Dr Grant R. Coren Pharma-Search Ltd Tel: +44 (0)1442 345 340 [email protected] August 2011 PSL2023 Pharma-Search Ltd The Organisation Committed to Improving the Lives of Patients Worldwide Celgene Corporation, a uniquely positioned entrepreneurial biopharmaceutical company, and its employees are working relentlessly to provide novel solutions for unmet medical needs in cancer and debilitating inflammatory diseases. Celgene’s goal is to provide next-generation innovative therapies that deliver quality outcomes for better healthcare. Celgene is dedicated to improving healthcare by delivering more disease-altering therapies to patients in need. In order to achieve this, there are more than 200 ongoing clinical trials at major medical centres worldwide using innovative compounds from Celgene. These promising drugs include many high-potential compounds in their rich and diverse regulatory pipeline. These investigational compounds may address immediate medical needs of patients with incurable haematological and solid tumour cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukaemia (CLL), non-Hodgkin’s lymphoma, glioblastoma, ovarian, pancreatic and prostate cancer. Celgene is committed to improving the lives of patients worldwide. By utilising the latest advances in molecular and cellular research to develop novel therapies that target the mechanisms of disease at their source, Celgene is making potentially life-saving treatments a reality for the millions of patients around the world fighting cancer and other debilitating diseases. Celgene has built a discovery, development, and commercialisation platform for drug and cellbased therapies that allows them to both create and retain significant value within their therapeutic areas of cancer and inflammatory diseases. This target-to-therapeutic platform approach integrates both small molecule and cell-based therapies and spans the key functions required to generate a broad, deep and diverse pipeline of new drugs and cell therapy candidates, including: cell biology, genomics, proteomics and informatics technologies for identifying and validating clinically important therapeutic targets; high throughput screening systems combined with diverse and focused compound libraries for discovering new drug leads; computational and medicinal chemistry for optimizing drug candidates; in vitro and in vivo models of disease for preclinical evaluation of drug efficacy and safety; a clinical and regulatory organisation highly experienced in the successful development of pharmaceutical agents. The ongoing development of immunomodulatory agents, cell-signalling inhibitors, as well as cellular and tissue therapeutics may allow Celgene to provide physicians/clinicians with a more comprehensive and integrated set of therapeutic solutions for managing complex human diseases such as cancer and inflammatory-related diseases. Assignment Brief – Clinical Scientist, CITRE Page 2 of 8 PSL2023 Pharma-Search Ltd Celgene History Celgene was initially founded as a unit of the Celanese Corporation in 1980. However, following the 1986 merger of Celanese Corporation with American Hoechst Corporation, Celgene was spun off as an independent biopharmaceutical company. In July 1998, the company received approval from the FDA to market THALOMID® (thalidomide) for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. In May 2006, Celgene received approval for THALOMID in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma. Over 145,000 patients have been prescribed the innovative product, THALOMID (thalidomide), through Celgene’s patented S.T.E.P.S. ® (System for Thalidomide Education and Prescribing Safety) delivery program. Designed in collaboration with the FDA for the restricted distribution of THALOMID, S.T.E.P.S. involves four of the 830 pending and issued patents in our expanding intellectual property estate. Assignment Brief – Clinical Scientist, CITRE Page 3 of 8 PSL2023 Pharma-Search Ltd In April 2000 an agreement was reached with Novartis Pharma AG to license d-MPH our chirally pure version of RITALIN®. The FDA subsequently granted approval to market d-MPH or FOCALIN® in November 2001. With products on the market, Celgene completed a merger with Signal Pharmaceuticals, Inc., a privately held biopharmaceutical company focusing on the discovery and development of drugs that regulate genes associated with disease. On December 31, 2002, Celgene acquired Anthrogenesis Corporation, a privately held New Jersey based biotherapeutics company and cord blood banking business, which has also pioneered the recovery of stem cells from human placental tissue following the completion of a full-term, successful pregnancy. In December 2005, Celgene received approval from the FDA to market REVLIMID® (lenalidomide) for the treatment of patients with transfusion-dependent anaemia due to Lowor Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. In June 2006, the FDA approved REVLIMID in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. REVLIMID is only available through a restricted distribution program called RevAssist®. EMEA approval for the REVLIMID® multiple myeloma indication (in combination with dexamethasone) was received in June, 2007. In March 2008, Celgene announced it had closed its $2.9 billion acquisition of Pharmion Corporation. The transaction brings together three medically meaningful therapies, REVLIMID®, THALOMID® and VIDAZA®, treating patients worldwide. These products are expected to generate multiple global revenue streams for accelerated financial growth as Celgene move into nearly 100 countries over the next five years and beyond. In January 2010, Celgene announced the acquisition of Gloucester Pharmaceuticals. The transaction brings to Celgene ISTODAX® (romidepsin), an approved therapy for the treatment of cutaneous T-cell lymphoma (CTCL), providing a strategic fit and expanding the company's presence in critical blood cancers. 2010 saw the approval of REVLIMID for multiple myeloma and deletion-5q MDS in Japan. In October 2010, Celgene announced the acquisition of Abraxis BioScience for $2.9 billion cash and stock to further enhance their expertise and position as a global leader in Oncology. This will further bolster their solid tumour pipeline with the acquisition of ABRAXANE, used in the treatment of metastatic breast cancer. Driving the commercial success and profitability of the company are marketed products, which include THALOMID® (thalidomide), REVLIMID® (lenalidomide), VIDAZA® (azacitidine) and ISTODAX®. Celgene also receives royalties from Novartis Pharma AG on sales of the entire RITALIN family of drugs, which are widely used to treat Attention Deficit Hyperactivity Disorder (ADHD). The company’s strong, growing revenue base will provide the financial strength to propel the successful development of new products for multiple indications that Celgene is committed to introduce over the next several years. Assignment Brief – Clinical Scientist, CITRE Page 4 of 8 PSL2023 Pharma-Search Ltd Celgene invests over 30% of its total revenue in the R&D that is essential to its future success. This significant investment clearly demonstrates its commitment to successfully expand the company’s profitable commercial franchises, advance its development pipeline, and discover new classes of compounds with meaningful medical benefit. The company’s broad, deep and proprietary pipeline of seventeen product development programs spans all phases from preclinical to Phase IV. Celgene is now an integrated biopharmaceutical company focused on discovering developing and commercialising innovative therapies to treat cancer and inflammation through gene and protein regulation. Celgene’s Commitment: At Celgene, we believe that a commitment to medical progress achieved through innovative science and lifeenhancing new therapies must go hand in hand with a corresponding promise to ensure that patients who can benefit from our discoveries have the opportunity to do so. www.celgene.com Assignment Brief – Clinical Scientist, CITRE Page 5 of 8 PSL2023 Pharma-Search Ltd CITRE®, the Celgene Institute for Translational Research Europe is providing Celgene with the platform to build an International presence in Seville, Spain. This is a significant investment by Celgene in the continued development of cutting edge technology in Europe. It will represent Celgene's first centre outside of United States exclusively dedicated to R&D. The centre will grow over the next three years to 30 international scientists intent on bridging the gap between basic science and clinical research, combining the talent and expertise from within the Biopharmaceutical industry and academia. The Celgene Institute of Translational Research Europe, occupies more than 1000 square meters divided into three floors within a building at the Cartuja93 Science and Technology Park in Seville - http://pctcartuja.es/Home/tabid/77/language/en-GB/Default.aspx CITRE will be the focal point for advanced biomedical research including regenerative medicine, personalized medicine and cellular therapies. CITRE will consist of five departments:Tumour bio banking, Bioinformatics, Placental stem cells, Epigenetics Cell signalling These functional departments will be further supported by five services:Cell culture Cytometry Electronic microscopy Genomics Proteomics Located in Seville, Spain, CITRE reflects a shared vision between Celgene and the public sectors of Spain and Europe to provide a bridge between the discoveries of basic research and their application in addressing the needs of modern medicine. Celgene invested approximately $800 million in research, traditionally investing about 30% of the company revenues in R&D. Assignment Brief – Clinical Scientist, CITRE Page 6 of 8 PSL2023 Pharma-Search Ltd Prerequisites Experience in the drug development process from preclinical research through clinical development in an industry setting Strong analytical and computational skills Experience in statistical laboratory testing methodologies Understanding of clinical databases A background in Oncology, Translational Research, Pathway Analysis, Quantitative Methods for Systems Biology, Network Analysis, or Simulation are a plus PhD Responsibilities include, but are not limited to: Conduct predictive biomarker data analysis based on cancer cell lines and primary tissue Provide critical input on clinical biomarkers and patient stratification for late stage compounds based on statistical analysis results Supervise bioinformatics personnel at the Sevilla site Personal Qualities: Champions change Leads courageously Networking Provides direction Structuring and staffing Thinks strategically Assignment Brief – Clinical Scientist, CITRE Page 7 of 8 PSL2023 Pharma-Search Ltd Skills/Knowledge Required: PhD in computational or life sciences (biologist or chemist with computational sciences training and experience or computational scientist with educational background in biology and chemistry) At least 5 years of relevant biotechnology or pharmaceutical industry experience Working knowledge of genomic technologies Expertise in the development of algorithms to analyze and interpret complex datasets particularly those associated with pharmacogenomics, pharmacogenetics and biomarker discovery Thorough understanding of statistical principles and their appropriate implementation Outstanding communication skills Customer-driven with the ability to collaborate across multiple Research functions and geographic sites Fluent in at least one of following statistical software programs: R, SAS, Matlab, or HPSS Package An attractive salary and benefits package will be offered, commensurate with experience, for the right candidates Relocation costs, where appropriate The package is negotiable, based upon the level of experience of the individual. Assignment Brief – Clinical Scientist, CITRE Page 8 of 8