$150K — $200K *
The Associate Director/Director Clinical Pharmacologist/Pharmacokineticist in the Department of Translational Medicine and Early Stage Clinical Development plays a central role in both clinical development and in support of nonclinical development at Alkermes. He/she will represent Clinical Pharmacology function and provide subject matter expertise on cross-functional project teams. He/she will assist in directing the clinical pharmacology development plan, synopsis preparation, clinical phase oversight, and reporting, and provide leadership of a multifunctional study team focused on clinical studies through design, delivery, and reporting, as well as ensuring scientific accountability. He/she will mentor junior and senior level scientists in the department in addition to being an individual contributor.
A core scientific responsibility is ensuring optimal doses and dosage regimens in patients, and as such, the successful candidate must be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). Working within the clinical development organization, the role supports multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Essential Areas of Responsibility: The incumbent may design, conduct and/or manage internal and external IND-enabling studies (eg: in vitro and in vivo nonclinical metabolism and PK), design and review clinical pharmacology study protocols and support clinical trials, conduct pharmacokinetic/pharmacodynamic modeling and analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions. A strong background in clinical pharmacology and pharmacokinetics combined with excellent leadership and communications skills are essential in this dynamic role. Clinical pharmacology experience with both small and large molecules in the area of oncology/immuno-oncology therapeutics is highly desired. Knowledge of, and direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes.
The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members. Upon completion of on-boarding, this person will be relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams.
Minimum Education & Experience Requirements:
Valid through: 7/2/2021