Amgen Jobshttp://www.amgen.jobs2012-05-26 20:54:52.596439USASouth San FranciscoAuto req 15588BR Job Posting Title CDM Systems Mgr Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen Job Description The CDM Systems Manager will serve as global manager and as a technical team point-of-contact within Electronic Trial Operations (ETO). This role will work with cross-functional Amgen teams of Clinical, Biostatistical, Data Management, Supply Chain, as well as with external representatives. This role will drive the design, implementation and maintenance of outsourced electronic solutions in support of clinical trials. The role will provide the technical oversight required to ensure adherence to study specific requirements, Amgen policies, procedures, standards all within a regulated environment. The position is expected to partner effectively with other CDM System staff to ensure high quality deliverables and to aggressively pursue opportunities to further propagate the use of ETO technology and services. Key Responsibilities include: • Lead study level system requirements meetings with internal and external clients • Design and oversee the development of study specific technical documents • Document possible risk and implement mitigation plans • Manage project related timelines and associated activities • Identify and track study-related technical issues to resolution • Provide a supportive framework for continuous process and quality improvements Other responsibilities include: • Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines. • Provide feedback on clinical protocols as it relates to electronic solutions and ensure the use of data standards and adoption of configurable modules • Procurement and program management of resources, timeline, and services from both internal and external service providers • Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology • Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers • Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives • Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished • Develop strong relationship with external providers (such Vendor Providers) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications 5 years of experience implementing clinical systems, such as CTMS, EDC, IVRS, IWRS, ePRO or other related technology in the pharmaceutical/biotechnology industry 3 years of biopharmaceutical clinical research experience Candidate will demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • 6+ or more years of experience in a technical role within clinical data management, clinical development, clinical setting, or IS/IT • Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Experience successfully implementing and IVR and IWR systems • Work experience integrating other clinical technologies including but not limited to such technologies such as eClinical, RAVE, EDC or other related technology in the pharmaceutical/biotechnology industry • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Working knowledge of Good Clinical Practices and Global Regulatory regulations as applicable • Previous line management experience2012-05-17 20:57:32United StatesAmgenCalifornia15588BRCASouth San Francisco, CA28771038http://www.amgen.jobs/xml/28771038/jobUSASouth San FranciscoAuto req 14252BR Job Posting Title Principal Scientist - Drug Development for Metabolic Diseases Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Amgen Job Description We are seeking a highly motivated individual to be one of the leaders in Amgen San Francisco engaged in drug development related to metabolic diseases. This incumbant will be expected to interact seamlessly and collaboratively with project leaders in metabolic and other functional areas to help guide efforts to discover novel therapeutics. The successful incumbant must have exceptional scientific leadership, managerial and verbal and written communication skills, and be able to function optimally in a team-based/collaborative environment. Additional the incumbant will have the ability to critically evaluate data and a thorough knowledge and understanding of the drug development process. Basic Qualifications - Doctorate degree & 5 years of scientific experience OR - Master’s degree & 12 years of scientific experience OR - Bachelor’s degree & 15 years of scientific experience Preferred Qualifications Ph.D. in Life Sciences, Pharmacology, or related discipline. 7+ years of relevant work experiences following post-doctoral training with world-class expertise in metabolic diseases for performing hands-on experiments in academia or industry Experience in the pharmaceutical or biotech industry Outstanding track record of successful research, including publication in peer-reviewed journals and patent filings Strong back ground in cell biology, various cell culture systems, expression systems, molecular biology, biochemical assay development, and good understanding of relevant in vivo models Ability to act as a scientific liaison and project facilitator and expertise in database management and project tracking Good written and oral communication skills Good organizational and multi-tasking skills2012-03-21 18:37:30United StatesAmgenCalifornia14252BRCASouth San Francisco, CA27297592http://www.amgen.jobs/xml/27297592/jobUSASouth San FranciscoAuto req 14287BR Job Posting Title Principal Scientist Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Amgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. The successful employee will provide scientific and managerial leadership to a group of scientists/associates as well as manage collaborations for the Genome Analysis Unit (GAU), a strategic innovation group within Discovery Research at Amgen. The group is based in 3 separate sites and consists of 31 staff members. The group operates semi-autonomously but also collaboratively across all Research to deliver large molecule therapeutics for oncology, metabolic disorders, and inflammation, as well as to develop innovative platform technologies that enable drug discovery. The successful employee is expected to be knowledgeable in cancer biology and/or other areas of disease biology that are/is of interest to Amgen Research. The employee is expected to partner with the leads of the computational biology group within the GAU to interpret complex data analysis, to decipher and develop hyphotheses for new therapeutic targets, and design in vitro and in vivo studies to characterize impact of target modulation, and manage a wide range of interdepartmental project collaborations. The employee must possess industry experience, experience in staff management, ability to harmonize between different teams within Discovery Research, as well as with external groups including Molecular Sciences, Clinical Immunology, and Research Imaging Sciences for effective collaboration in a matrixed environment. The employee will be expected to contribute to strategic, tactical, and operational discussions for the GAU. Knowledge of Amgen Research environment is a plus. Basic Qualifications • Doctorate degree & 5 years of scientific experience OR • Master’s degree & 12 years of scientific experience OR • Bachelor’s degree & 15 years of scientific experience Preferred Qualifications • Doctorate degree in life sciences and 5 or more years of directly related experience • 5+ years of experience in industry with management responsibilities, demonstrated ability to effectively interface with leaders across an organization and manage collaborations, project team leadership • Relevant knowledge of the development of protein therapeutics, molecular and cell biology, genetics, cancer biology, next-gen-sequencing, strong written and verbal communication2012-03-09 18:35:23United StatesAmgenCalifornia14287BRCASouth San Francisco, CA27037842http://www.amgen.jobs/xml/27037842/jobUSASouth San FranciscoAuto req 14023BR Job Posting Title Sr Scientist - Pharmaceutics Career Category Scientific Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Amgen Job Description The position responsibilities include independently designing and conducting preformulation characterization of small molecules, developing formulations to support in-vivo animal studies, solid state characterization and salt and form selection for clinical candidate. The position responsibilities also include developing small molecule parenteral formulation for clinical use. A successful candidate will participate and represent pharmaceutics in a multi-disciplinary team, supervising scientific projects, providing critical evaluation of scientific data and results, and providing technical mentoring and expertise to associate level staff. Basic Qualifications Doctorate degree & 2 years of scientific experience OR Master’s degree & 8 years of scientific experience OR Bachelor’s degree & 10 years of scientific experience Preferred Qualifications A Ph.D. in Pharmaceutical Chemistry, Physical Chemistry, Physical Organic Chemistry, Organic Chemistry, or scientific field 3+ years of relevant post doctoral and industrial experience. A thorough understanding of basic pharmaceutics such as solubility, physicochemical properties, and chemical stability. Experience in developing small molecule parenteral clinical formulation as well as an understanding and familiarity with the solid-state characterization techniques (DSC, TGA, XRPD, microscopy, moisture uptake, HPLC etc). Good communication skills (oral and written), good computer skills, and problem solving skills are required.2012-02-24 19:34:10United StatesAmgenCalifornia14023BRCASouth San Francisco, CA26740014http://www.amgen.jobs/xml/26740014/jobUSASouth San FranciscoAuto req 13691BR Job Posting Title Sr Counsel - Biotech (Large Molecule) Career Category Law/Legal Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen Job Description Position may be based in our Thousand Oaks, CA or San Francisco, CA locations. This role will be involved in patent application drafting and prosecution, research and licensing agreements, legal opinions and strategies, trademark and copyright matters, and potentially patent litigation support. The role will be responsible for identifying patentable subject matter; drafting, filing and prosecuting patent applications; developing legal strategies relating to products and product candidates; analyzing patents and preparing infringement, validity and freedom-to-operate opinions; conducting due diligence in support of licensing activities; negotiate and draft research agreements; and provide advice and counsel to R&D and business personnel on a variety of IP related matters. Will work individually and in legal teams and cross-functional R&D and business teams. Basic Qualifications - JD degree from an accredited law school and admission to practice law required - 4 Years of experience practicing patent or intellectual property law Preferred Qualifications - 10 plus years of experience preferred Experience in all aspects of U.S. and foreign intellectual property law relating to biotechnology, preferably in the pharmaceutical industry with a law firm or corporation. - An advanced degree or experience in biology is considered a plus. - Excellent analytic, legal drafting and oral and written communication skills. - Strong management and leadership skills as well as a strong client service focus and the ability to work independently and in teams, efficiently, prioritize workflow, meet demanding deadlines, and manage multi-dimensional projects in a fast-paced environment.2012-02-01 02:26:51United StatesAmgenCalifornia13691BRCASouth San Francisco, CA26231381http://www.amgen.jobs/xml/26231381/jobUSASouth San FranciscoAuto req 12764BR Job Posting Title Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen Job Description This role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site. The CDM Systems Mgr – EDC Operations is the technical Subject Matter Expert and point-of-contact to ensure electronic clinical data management operations of Amgen’s global Electronic Data Capture Operations service. The manager will have operational responsibility for delivery of electronic data collection systems such as Medidata Rave and Oracle InForm. These responsibilities include the delivery of EDC system capabilities, design and implementation of key system integrations, and the development of system-related EDC best practices. The position is expected to partner effectively with other CDM Systems staff to seamlessly ensure high quality deliverables such as EDC platform upgrades, EDC architecture design, integrations with internal and external clinical systems, custom report programming, and other clinical data management activities related to the use electronic data capture technology. Through active service management of service providers the manager is responsible for representing Amgen in supporting the Operational Management Team and Functional Management Team governance bodies in partnership with Amgen Global Supplier Services, ensuring quality service delivery and supplier performance. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 3+ or more years of experience in a technical role within clinical data management, clinical development, or IS/IT • Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Experience successfully implementing and operating clinical data management collections systems specifically EDC platforms such as Medidata Rave and/or Oracle InForm • Medidata Rave, Oracle InForm hands-on operational and system knowledge desirable • Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary • Knowledge of ITIL v3 and basic Industry IS best practices • Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills • Excellent time management and organization skills required • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable • Leadership Skills : The manager, EDC Operations will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will have extensive clinical trial technical experience and leadership expertise. He or she will have substantial technical background to deliver the EDC operations associated with the Amgen portfolio. With strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues. The ideal candidate has a proven track record and experience in either working in and/or leading a technical team. The candidate must be able to represent Amgen’s business requirements and needs by effective partnering and working with outsourced service delivery partners such as an FSP, ensure operational experience with clinical database management systems (preferably Medidata Rave and Oracle InForm) and have strong communication skills to maintain a high level of transparency between CDM systems centers of excellence, clinical study team members, CDM business units, and other stakeholders.2011-11-28 21:31:18United StatesAmgenCalifornia12764BRCASouth San Francisco, CA25067023http://www.amgen.jobs/xml/25067023/job