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.
The Clinical Research Scientist Director for Immuno- Oncology (I/O) Global Clinical Research & Development will work closely with the Head, Immuno-oncology Programs and the Executive Director of the CRS Group to develop the I/O portfolio. This individual will work across the Hematology and Oncology Therapeutic Areas (TA) and in collaboration with the Head of the I/O Thematic Centers of Excellence within Early Drug development, Translational Research and Business Development. In addition, s/he will assist the Head of Immuno-oncology programs in the preparation of the development strategies for early-stage programs with the goal of a seamless overall clinical development plan from internal Celgene programs and from corporate partnerships (Early-Stage Therapeutic Area, TA). In addition, this individual will be responsible for assisting with the evaluation and due diligence on external business development opportunities for Clinical R&D. They will serve as the Biology/Pathway disease expert.
He/she will represent CR&D as needed on behalf of the Head of Immuno-oncology programs, serving as immuno-oncology expert in scientific, strategic and tactical discussions both internal and external colleagues.
• Collaborate across Therapeutic Areas (TAs) to integrate the I/O strategy is being integrated into development plans and clinical trials.
• Contribute to the review and design of the clinical trials and development plan for successful design and execution of all protocols within I/O
• Develop key documents to summarize the evaluation and recommendation in-line with the Immuno-oncology programs.
• Contribute to I/O updates to Internal Committees (including governance committees)
• In close collaboration, with the Therapeutic Area Physicians and Scientists, drive cross-functional integration of clinical development activities to include coordinating across teams.
• Provide clinical project management support for ongoing and new research I/O activities.
• Stays abreast of internal and external developments, trends and other dynamics relevant to the conduct of oncology clinical trials globally. Maintains, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• Represent I/O programs, on behalf of the Head of Immuno-oncology programs, as requested, as a therapeutic area expert in both internal and external venues including the Global Project Teams, Governance Committees, clinical development teams, and advisory boards / steering committees, Key Opinion Leaders and investigators
• As part of the CR&D CRS Leadership team, define and standardize best practices for CR&D in I/O
• Actively participate in regular (e.g. quarterly) project review meetings
• Flag potential process improvement opportunities and drive/support execution
• Build the functional expertise of the I/O program and ensure adequate on boarding, program-specific and role-specific training is provided
MD, Advanced Practice Nurse, PhD, Pharm D., MS, or equivalent degree in life sciences or medically related field
•At least 16+ years related experience in life sciences or medically related field, including at least 4 years of clinical development experience in Biopharmaceutical Industry; prior immuno-oncology experience with check point inhibitors a plus.
• PhD, Pharm D., MPH, MS, or equivalent degree in life sciences or medically related field; prior immuno-oncology experience with check point inhibitors a plus.
• At least 6+ years related experience in life sciences or medically related field, including at least 4 years of clinical development experience in Biopharmaceutical Industry;
• Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 discussions with thought leaders.
• Proficiency in scientific and clinical data review and interpretation.
• Highly experienced in all aspects of the drug development process
• High level strategic thinking, critical thinking, problem solving and decision making skills
• Promotes a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication.
• Anticipates needs, assesses and manages business risks and organizational dynamics as well as their implications
• 10-20% Travel Required
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.
Req ID: 15001354
Primary Location: United States-New Jersey-Summit
Job: Medical Operations
Organization: Celgene Corporation
Employee Status: Director
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 20 % of the Time
Job Posting: 2015-06-22 00:00:00.0
Business Development, Business Process, Cancer Research, Clinic, Clinical Research, Engineering, Healthcare, Hematology, Management, Manager, Medical, Medical Research, Medical Technologist, Oncology, Project Manager, R&D, Research, Research Scientist, Sales, Science, Scientific, Scientist, Technology, Travel Nurse