描述
Janssen Research & Development, LLC, is recruiting for a Clinical Pharmacology Specialist (Senior Associate Scientist), located in Spring House, PA or Titusville, NJ.
The CP Specialist role within Clinical Pharmacology and Pharmacometrics (CPP) will provide clinical pharmacology related support for scientific operational activities at the study level for Phase 2/3 studies from pharmacokinetic (PK) and/or immunogenicity (antidrug antibody or ADA) sample collection through to the finalization of data across our multiple therapeutic areas (TAs).
Works in close collaboration with the CP Leader (CPL) and various partners within the team (e.g., Data Management, Bioanalytical) and implement the day-to-day scientific operations pertaining to all CP data aspects for the programs they are assigned to.
Applies scientific operational excellence in accordance with timelines and overall project goals and, leads implementation of processes across programs.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Key Responsibilities:
- Accountable for end to end (E2E) CP related scientific operational activities from late phase sample collection (e.g. CRF review, lab manuals, investigator meeting slides, etc.) through to final data
- Follow-up on items related but not limited to sampling schemes, data- collection/quality/cleaning and addressing questions from business partners such as bioanalytical, data management, clinical scientist, etc.
- Works closely together with bioanalytical departments (BDS/BAN) to ensure sample analysis in support of decision making (eg. Interim Analysis/Submission) is delivered in a timely manner
- Coordinating PK/ADA sample tracking and resolves issues with BDS/BAN
- Facilitates data handling and transfer to the CRO for any PK/PD or immunogenicity analysis
- Authority in study processes related to CPP deliverables/contributions and facilitates implementation of standard methodologies across compound development programs and across TA’s. Applies subject matter expertise to guide CPLs and business partners in improving PK/PD/ADA data streams
- Works optimally in handling dataflows related to CP deliverables in accordance with timelines and overall project goals.
- Represents CPP in cross-functional study working group meetings
- Applies relevant technical trainings and lessons to daily responsibilities, with a focus on the opportunistic delivery of value/impact
- Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles
资格
Qualifications
Education:
- B.S., M.S. or equivalent with 2 years of industrial experience or CRO experience in areas of clinical operations (clinical pharmacology studies preferred), bioanalytical / sample management, and/or data management is required
Experience and Skills:
Required:
- Excellent project management and organizational skills
- Ability to build and developing relationships inside and outside the department
- Ability and willingness to work in a cross-functional team environment
- Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently
- Making valuable contributions to the organization, assuming responsibility and accountability for efficiently completing assignments or tasks
- Self-motivated with the ability to work independently with minimal direction
- Actively identifying new areas for learning and application to the job
- Good sense of cultural sensitivity and diversity
- Experience with MS Office suite
Other:
- Ability to communicate effectively, verbally and in writing, to individuals and groups at various levels in the organization
- Travel time estimated for domestic and international travel to be approximately 5% of time
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
The base pay range for this position is $84,000 - $135,700. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .