Scientist II/Sr. Scientist, Clinical Pharmacology

Biogen SANDBOX • Cambridge, MA

1d

About The Position

The Scientist II/Senior Scientist, Clinical Pharmacologist is responsible for the clinical pharmacology and pharmacometric deliverable for clinical development assets from phase I-III. The responsibility include to develop a clinical pharmacology plans and dose selection and prediction using mathematical and statistical models to study complex interactions between drug and patients, between biological systems and to understand disease progression and impact of patient stratification on disease progression. He/She contributes to evaluating various clinical pharmacology and modeling strategies and building clinical pharmacology and pharmacometrics infrastructure. The Scientist clinical pharmacology serve as Clinical Pharmacology rep on programs with high quantitative intensity and will collaborate closely with Clinical Pharmacology on advanced pharmacology models. 1. Under supervision drives the development and execution of the Quantitative Pharmacology and Pharmacometric Strategy of clinical development teams. Also support regulatory responses related to clinical pharmacology and pharmacometrics. 2. Performs advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection. Interprets and presents results and recommends appropriate actions. 3. Develops and maintains strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent. 4. Develops and maintains scientific awareness and presence in Quantitative Pharmacology and Pharmacometric Science, publishes manuscripts and posters, presents at Scientific Conferences and other scientific forums. Qualifications Minimum of 3 years (PhD) or 5 years (MSc) of experience working as a clinical pharmacologist, DMPK or pharmacometrician. Experience developing advanced PK/PD models to aid in research and development decision making Knowledge of Health Authority per Additional Information The Scientist II/Senior Scientist, Clinical Pharmacologist is responsible for the clinical pharmacology and pharmacometric deliverable for clinical development assets from phase I-III.

Requirements

• Minimum of 3 years (PhD) or 5 years (MSc) of experience working as a clinical pharmacologist, DMPK or pharmacometrician.
• Experience developing advanced PK/PD models to aid in research and development decision making
• Knowledge of Health Authority

Responsibilities

• Drives the development and execution of the Quantitative Pharmacology and Pharmacometric Strategy of clinical development teams.
• Support regulatory responses related to clinical pharmacology and pharmacometrics.
• Performs advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection.
• Interprets and presents results and recommends appropriate actions.
• Develops and maintains strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
• Develops and maintains scientific awareness and presence in Quantitative Pharmacology and Pharmacometric Science, publishes manuscripts and posters, presents at Scientific Conferences and other scientific forums.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees