Bioverativ Inc. Waltham , MA 02154
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.
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.
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.
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.