Sr. Scientist, Clin Pharm
Other Locations:US- NJ- Summit West
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 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 is one of the fastest growing biopharmaceutical companies globally. We focus on the discovery, development, and commercialization of innovative therapies for unmet needs in hematology, oncology, and immune-inflammatory disease.
- Serve as the department lead person for clinical pharmacokinetics (PK) in studies and project teams.
- Perform and accountable for non-compartmental PK data analysis
- Plan, implement, interpret and report model-based PK and pharmacodynamics (PD) analysis including population PK, PK/PD modeling and simulation, meta-analysis for assigned compounds under clinical development from Phase 1 to 3 and in life cycle management.
- Assist in selection of doses and dosing algorithms for clinical development.
- Contribute to regulatory documents and meetings; take a lead role in writing and reviewing response to regulatory queries on clinical pharmacology/PK.
- Provide input to clinical study designs and PK logistics.
- Assist in the development of the statistical analysis plan.
- Scientific oversight of CROs with respect to PK and PK/PD tasks.
- Strong quantitative skills with hands-on experience in advanced data analyses, i.e. population PK, PK/PD, and exposure-response analyses.
- Competent in the use of various modeling software (NONMEM, SAS, Splus, R, etc.) and standard noncompartmental data analysis software (Phoenix/WiNonlin).
- Excellent written and verbal communication skills and demonstrated oral presentation skills.
- Ability to work in a cross-functional team environment and to work simultaneously on multiple projects.
- Knowledge and experience on clinical database, PK/PD data compilation and manipulation with scripting software of SAS, R and/or Splus.
- Familiarity with all stages of drug development from discovery through Phase 4, including experience in the preparation of clinical pharmacology sections of regulatory submissions for IND- and/or NDA-stage projects.
- Able to anticipate problems at project level.
- Proven track record of scientific approach to complex problem solving.
- Demonstrate in-depth, scientific-directed, innovative thinking.
- Work with multiple studies/programs with moderate to limited oversight
- Sets own priorities with some guidance
- Keeps manager and key stakeholders informed on programs to assure alignment
- Through knowledge of the global drug development process and key deliverable by multiple in collaboration from discovery to commercialization
- Through and in depth knowledge of PK/PD and its application and impact on drug development
- Thorough understanding of ADME principles in drug development
- Good document authoring and review/edit skills
- Recognize risk and propose contingency plans.
- Acts as a resource to peers, multi-disciplinary teams, and senior management.
- Develops constructive relationships across organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams.
- Communicates within the larger organization and external community.
Requirements & Education:
Advanced degree (Pharm.D. or Ph.D.) or equivalent degree in scientific discipline with a minimum of 3 years' experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics