Associate Director/Director, Clinical Pharmacology - Cambridge, MA | Biospace
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Associate Director/Director, Clinical Pharmacology

WAVE Life Sciences

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Location:
Cambridge, MA
Posted Date:
6/28/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Clinical Pharmacology representative on clinical and study teams and works in close collaboration with multidisciplinary team to progress drug candidates from R2D transition through preclinical and clinical development to successful approval.
•   Responsible for the design, planning, oversight as well as the analysis, interpretation and reporting of results of Clinical Pharmacology studies.
•   Interfaces with discovery research colleagues during pre-clinical stages of development to plan and ensure sufficient PK/PD knowledge exists for translation to clinic.
•   Applies scientific knowledge and experience to cover a breadth of areas including the design, execution, and interpretation of ADME, CYP inhibition/induction, transporter, PK/PD and clinical pharmacology studies.
•   Applies quantitative skills to support model-based drug development and address complex issues via modeling and simulation.
•   Responsible for clinical pharmacology contributions to regulatory documents and responses.
•   Understands and effectively applies appropriate regulatory guidelines to drug development.

Requirements

•   Demonstrates a sound knowledge of clinical pharmacology and PK/PD principles, and possess strong modeling and simulation skills
•   Proficient in PK modeling software/platforms including but not limited to NONMEM, R and population PK/PD modeling.
•   Ability to innovate and think creatively to support development activities and drug development process.
•   Effective communication and interpersonal skills.
•   Strong presentation skills.
•   Experience working within a start-up or small biotech business environment
•   Prior experience in industry exploring or utilizing oligonucleotide synthesis is preferred but not required
EDUCATION/EXPERIENCE:
•   Ph.D. degree, Pharm D or equivalent in clinical pharmacology, pharmacokinetics, pharmacometrics, or a related field with more than 5 years of relevant industrial experience
•   Demonstrable and outstanding track record of aptitude/problem solving in the field of clinical pharmacology
•   Adept at presentation of clear and accurate reports for internal and external projects
•   Capacity to work flexibly and efficiently in a dynamic, fast-paced work environment
•   Collaborative and self-motivated team player, Oligonucleotide experience preferred