Posting Title:
Associate Director, Pharmacometrics, Clinical Pharmacology and Pharmacometrics
Group
Job Description:
The Associate Director, Pharmacometrics, Clinical Pharmacology and
Pharmacometrics Group, serves as the Clinical Pharmacology and Pharmacometrics
lead on early program teams providing strategic leadership and execution of
Quantitative Pharmacology plans that include characterization of the
Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) of the drug
candidate. This person also executes and/or oversees development and
application of Quantitative models, providing rationale for dose regimen
selection, safety margin assessment and identification of circumstances where
dose adjustment should be considered.
* Responsible for providing key components of the Early Development
Plan (strategy/analysis through final reports) and for providing input and
scientific opinion to project teams, line management, and governance bodies.
* Leads Clinical Pharmacology and Pharmacometrics study efforts (eg,
study design, protocol concepts/protocols preparation, clinical phase
oversight, and reporting) within assigned programs to yield high value PK/PD/DM
insight for future critical decisions. Analyzes results, interprets, and
recommends action based on study results.
* Works with Clinicians, Quantitative Sciences and DMPK/PD to ensure
appropriate study designs are achieved for successful implementation of data
analyses and accomplishment of intended study outcomes.
* Works with study and program teams to achieve program goals and
provide deliverables in approved timeframes.
* Identifies program and study-specific issues. Generates potential
solutions to issues and proposes those solutions to management and/or study
teams.
* Utilizes Advisory Board members, Thought Leaders, and Academic
Collaborators as necessary to add effective value to our development programs.
* Develops and maintains strong knowledge of best regulatory practices,
analytical technology and drug development precedent for Clinical Pharmacology
and Pharmacometrics.
* Provides regulatory strategy and is responsible for Clinical
Pharmacology and Pharmacometrics sections of regulatory documents.
Qualifications:
* Employs continuous improvement in knowledge and practical
understanding of Mechanistic/Systems Pharmacology, PPDM, Clinical Pharmacology
and Pharmacometrics and application of this knowledge in the program team
setting.
* Understands and is able to apply appropriate regulatory and ICH
guidelines in the design of all studies.
* Can manage a diverse, time-sensitive workload.
* Possesses strong English communication skills requiring minimal
oversight in drafting grammatically correct written documents and making oral
presentations.
* 4+ years of direct industry experience in Clinical Pharmacology and
Pharmacometrics , advanced modeling & simulation, and program team support.
* Some experience in drafting early drug development strategy and
designing/implementing studies for multiple compounds including PPDM data
analyses for both biologics and small molecules.
* Demonstrates a strong understanding of: 1) PK/PD principles,
physiology/pharmacology and pathology; 2) operational and scientific aspects of
early development studies; and 3) quantitative analysis.
Qualifications:
Ph.D., M.D./Ph.D., or Pharm.D. in biomedical engineering, applied pharmacology,
statistics, pharmacokinetics, or a related field.
If interested; Please send resume to Isaac Blum at
[email protected]<mailto:[email protected]> or Ivan Nestorov at
[email protected]<mailto:[email protected]>
Ivan Nestorov, PhD
Sr. Director, Pharmacometrics
Biogen Inc
225 Binney Street
Cambridge, Massachusetts 02142
Tel: 617-679-2541
Email: [email protected]