Senior Director, Clinical Pharmacology

2 weeks ago

Lexington, United States Keros Therapeutics Full time

Job Summary: The Director, Clinical Pharmacology & Pharmacometrics, you will be responsible for the clinical pharmacology and pharmacometric deliverables for clinical development assets from phase I-III and developing a clinical pharmacology plan 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. This person will contribute to evaluating various clinical pharmacology and modeling strategies and building clinical pharmacology and pharmacometrics infrastructure.

Primary Responsibilities:

* Serve as Clinical Pharmacology Lead on programs.
* Drive the development and execution of the Pharmacology and Pharmacometric Strategy of clinical development teams.
* Support regulatory responses, dossiers, and/or other regulatory documents needed as it relates to clinical pharmacology and pharmacometrics.
* Lead preclinical and clinical pharmacology study efforts (e.g., 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.
* Analyze results, interprets, and recommends action based on study results.
* Perform advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection.
* Interpret and present results and recommends appropriate actions.
* Develop and maintain strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
* Develop and maintain scientific awareness and presence in Quantitative Pharmacology and Pharmacometric Science, publish manuscripts and posters, present at Scientific Conferences and other scientific forums.

Attributes:

* Ability to evaluate, propose and implement creative approaches in a fast-paced environment.
* Ability to work effectively with minimal structure understanding when to reach out for help or ask questions.
* Flexibility to sometimes work outside of one's comfort zone; effective amidst ambiguity. Motivated to work in a small organization to develop treatments for difficult, rare diseases.
* Strong communication skills to work effectively across functions, vendors and levels of the company.
* Highly organized to manage multiple deliverables and activities.

Qualifications:

* PhD degree in clinical pharmacology, pharmacy, biomedical engineering, statistics, applied mathematics, or a related field. MSc degree with relevant experience is also acceptable.
* 5+ years (PhD) or 8+ years (MSc) of experience working as a clinical pharmacologist, DMPK or pharmacometrician within biotech/ pharmaceutical industry.
* Experience developing advanced PK/PD models to aid in research and development decision making.
* Knowledge of Health Authority perspective on clinical pharmacology and use of modeling and simulation.
* Experience with use of PK/PD software packages such as Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS: preferred.

#LI-Hybrid

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