Sr. Clinical Project Scientist Clinical Pharmacology for Early Development-00000TWV
Description
Janssen Research & Development Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Clinical Project Scientist preferably located in Beerse, Belgium; Leiden, The Netherlands, Spring House, PA or Raritan, NJ.
This individual is recruited to work in the Oncology Therapeutic Area Experimental Medicine Early Development (eMED) group on novel anti-cancer compounds in early clinical development and will be responsible for design, planning, development, and implementation of oncology clinical trials with particular focus on clinical pharmacology endpoints (relative/absolute bioavailability, mass balance, drug-drug interaction, special populations [hepatic or renal impairment], thorough QTc etc) These studies may be conducted in healthy subjects or in subjects with cancer. This position will report to the Early Development Clinical Leader.
The Sr. Clinical Project Scientist position has the following essential job functions:
- Work in cross-functional Early Development Clinical Team to plan, execute and monitor clinical projects for studies in subjects with cancer.
- Work in cross-functional Clinical Pharmacology Team to plan, execute and monitor clinical projects for studies in healthy subjects.
- Craft essential conditions that are necessary to efficiently determine the safety, efficacy and pharmacokinetics of the assigned compounds in close working relationships with other key support areas including Global Clinical Operations, Clinical Pharmacology and Clinical Pharmacology Operations, Translational Research, other support functions
- Develop and lead clinical research protocols, informed consent and other trial-related documents.
- Collaborate closely with the Study Responsible Physician/Medical Monitor for oncology ED clinical trials.
The Sr. Clinical Project Scientist provides input and review of Case Report Forms (CRFs), other data collection tools, Statistical Analysis Plan (SAP), and Data Management Plan (DMP). The position provides input and review on scope of work central lab, central ECG and other vendors, and develops trial-related Safety Management Plan (SMP) and Medical Review Plan (MRP). Sr. Clinical Project Scientist gives input in site selection, and contributes to investigator meeting presentations and site initiation visits. This individual will also serve as a liaison to clinical sites and other vendors, as well as internal/external customers.
The Sr. Clinical Project Scientist will play a lead role in the design, execution, oversight, and interpretation of TMED clinical trials with particular focus on clinical pharmacology, and will be a key member of the early development clinical or clinical pharmacology study teams.
Qualifications
- An advanced degree such as a Ph.D. or Pharm. D or strong clinical research experience is preferred.
- A minimum of 4 years of clinical research and development, clinical trial operations, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.
- Experience in oncology therapeutic area and in early oncology clinical trials and experience with clinical pharmacology studies is preferred.
- Significant experience with the development of protocols, case report forms, informed consent and study initiation and monitoring is required.
- Excellent written communication, oral communication, and presentation skills are also essential.
- The individual must have demonstrated ability to work in a matrix team environment. The willingness to travel up to 20% of the time is required.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations:North America, Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Janssen Pharmaceutica N.V. (7555)
Travel:Yes, 10 % of the Time
Job Function: Pharmacokinetics
Description
Janssen Research & Development Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Clinical Project Scientist preferably located in Beerse, Belgium; Leiden, The Netherlands, Spring House, PA or Raritan, NJ.
This individual is recruited to work in the Oncology Therapeutic Area Experimental Medicine Early Development (eMED) group on novel anti-cancer compounds in early clinical development and will be responsible for design, planning, development, and implementation of oncology clinical trials with particular focus on clinical pharmacology endpoints (relative/absolute bioavailability, mass balance, drug-drug interaction, special populations [hepatic or renal impairment], thorough QTc etc) These studies may be conducted in healthy subjects or in subjects with cancer. This position will report to the Early Development Clinical Leader.
The Sr. Clinical Project Scientist position has the following essential job functions:
- Work in cross-functional Early Development Clinical Team to plan, execute and monitor clinical projects for studies in subjects with cancer.
- Work in cross-functional Clinical Pharmacology Team to plan, execute and monitor clinical projects for studies in healthy subjects.
- Craft essential conditions that are necessary to efficiently determine the safety, efficacy and pharmacokinetics of the assigned compounds in close working relationships with other key support areas including Global Clinical Operations, Clinical Pharmacology and Clinical Pharmacology Operations, Translational Research, other support functions
- Develop and lead clinical research protocols, informed consent and other trial-related documents.
- Collaborate closely with the Study Responsible Physician/Medical Monitor for oncology ED clinical trials.
The Sr. Clinical Project Scientist provides input and review of Case Report Forms (CRFs), other data collection tools, Statistical Analysis Plan (SAP), and Data Management Plan (DMP). The position provides input and review on scope of work central lab, central ECG and other vendors, and develops trial-related Safety Management Plan (SMP) and Medical Review Plan (MRP). Sr. Clinical Project Scientist gives input in site selection, and contributes to investigator meeting presentations and site initiation visits. This individual will also serve as a liaison to clinical sites and other vendors, as well as internal/external customers.
The Sr. Clinical Project Scientist will play a lead role in the design, execution, oversight, and interpretation of TMED clinical trials with particular focus on clinical pharmacology, and will be a key member of the early development clinical or clinical pharmacology study teams.
Qualifications
- An advanced degree such as a Ph.D. or Pharm. D or strong clinical research experience is preferred.
- A minimum of 4 years of clinical research and development, clinical trial operations, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.
- Experience in oncology therapeutic area and in early oncology clinical trials and experience with clinical pharmacology studies is preferred.
- Significant experience with the development of protocols, case report forms, informed consent and study initiation and monitoring is required.
- Excellent written communication, oral communication, and presentation skills are also essential.
- The individual must have demonstrated ability to work in a matrix team environment. The willingness to travel up to 20% of the time is required.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations:North America, Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Janssen Pharmaceutica N.V. (7555)
Travel:Yes, 10 % of the Time
Job Function: Pharmacokinetics