Senior Director, Clinical Pharmacokinetics, Modeling and Simulation - Summit, NJ | Biospace
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Senior Director, Clinical Pharmacokinetics, Modeling and Simulation


Summit, NJ
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description


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

Responsibilities include:

1.   Supervise PK data analysis and interpretation with appropriate tools

2.   Strategize PK and PK/PD investigations in Phase I, II, III and IV studies

3.   Strategize meta-analysis of population PK and PK/PD data

4.   Manage CROs to conduct meta-analysis and report PK and PK/PD data

5.   Evaluate the relationship between exposure and pharmacodynamic (PD)             properties for compounds from discovery to proof of activity, and to    late           stage Phase 3 development

6.   Set PK and PK/PD strategies and overall clinical pharmacology                           characterization strategies for compounds under drug development for    global regulatory submission

7.   Supervise and/or prepare the eCTD dossiers of sections 2.5, 2.7.1 and               2.7.2 for NDA submission

8.   Provides expert scientific and strategic consultation to R&D, Regulatory               Affairs, Regulatory Agencies, and all levels of management on    critical             decisions and development plans for multiple projects across multiple                 therapeutic areas





Advanced degree (Pharm.D. or Ph.D.) in
pharmacokinetics/pharmacology or relevant life sciences, with a minimum of 16-years' experience in PK/PD and
pharmacometric analysis

Skills/Knowledge Required:

?Advanced degree (Pharm.D. or Ph.D.) in a relevant scientific discipline which includes pharmacokinetics and a minimum of 16-years'  experience analyzing preclinical and clinical pharmacology studies.

?Expert understanding of the global drug dev. process and collaborations among multiple functions from discovery to commercialization. In-depth knowledge of the drug development process, GLP and GCP.

?Innovate with PK/PD and pharmacometrics on strategic decisions at all phases of clinical dev. process

?Innovate with effective and efficient clinical pharmacology characterization of drugs

?Expert scientific writing skills to explain complexity with clarity

?Interacts effectively with managers from various disciplines; serves as expert and internal consultant on assigned area and liaises with partners on projects

?Directly influences drug development decisions in collaboration with internal and external partners

?Creates and implement strategy for improved processes

?Successfully manages team conflict(s) to resolution and improves team collaboration

?Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/ performance)

?Leads departmental training on scientific and process improvements

?Leads teams within department and across functions,  mentors departmental personnel

?Abreast with new scientific development and leads change

?Anticipates and proactively address issues/problems on projects and study teams

? Source of innovative solutions

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.