Clinical Pharmacology Lead

Bioverativ Inc. Waltham , MA 02154

Posted 3 months ago

Reporting to the

Executive Director, Clinical Pharmacology, the CP Lead will be responsible,under appropriate supervision, for the creation and application of PK/PDanalyses to support drug development and decision making for early and latestage hematology and complement programs including cell and gene therapy. The CPLead plays a key role incorporating innovative clinical strategies, model-baseddrug development and utilizing novel quantitative approaches to clinicaldevelopment. The candidate will contribute to multi-disciplinary teams acrossR&D providing guidance, planning, execution, analysis and interpretation ofclinical pharmacology components across the programs.

RESPONSIBILITIES

  • Serves as CPrepresentative on clinical and study teams and works in close collaborationwith multidisciplinary team to progress drug candidates from pre-IND throughearly phase/late phase to successful approval.

  • Responsible forthe design, planning, oversight as well as the analysis, interpretation andreporting of results of Clinical Pharmacology studies.

  • Interfaces with

Research and works closely with discovery research during the pre-clinicalstages of drug development to ensure sufficient PK/PD knowledge exists fortranslation to the clinic.

  • Appliesquantitative skills to support model-based drug development and address complexissues via modeling and simulation.

  • Responsible forclinical pharmacology contributions to regulatory documents and responses.

  • Understands andeffectively applies appropriate regulatory guidelines to drug development.

  • May serve asClinical Pharmacology representative at regulatory, advisory group, and otherinteractions to develop effective therapies.

  • Demonstratesinnovative approaches to drug development in rare disease field, includingsmall patient populations and sparse sampling.

QUALIFICATIONS

  • 1-4 years'relevant pharmaceutical PK/PD industry experience; demonstrates a soundknowledge of clinical pharmacology and PK/PD principles.

  • Possess strongknowledge of FIH study design

  • Proficient inPK modeling software/platforms.

  • Effective communicationand interpersonal skills.

  • Strongpresentation skills; strong team player.

EDUCATION

  • Ph.D. degree inclinical pharmacology, pharmacokinetics, pharmacometrics, mathematics,engineering, computational biology or a related field.
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Clinical Pharmacology Lead

Bioverativ Inc.