Senior Director, Quantitative Pharmacology

Remote

Full time

R12831

• As a leadership role in Quantitative Pharmacology team at Quantitative Translational Research (QTR) department, this role will oversee clinical Pharmacology activities, assist in department technical growth and contribute to key metrics of success of the Clinical Pharmacology team across all stages of clinical development. The role will also support the head of Quantitative Pharmacology, in managing/growing function team, mentoring/training junior scientists, and overseeing project-level clinical pharmacology activities, leading development of SOP/WP or cross-functional working process.
• Oversee clinical pharmacology deliverables related to pre-IND, IND, phase1-3,
  Pharmacokinetics (PK) ,
  Pharmacokinetics-Pharmacodynamics (PK/PD) reports and regulatory submissions as well as review and approve Clinical Pharmacology reports and analyses.
• Oversee clinical pharmacology strategy and provide input into clinical development strategy and activities related all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development.
• Serve as a Clinical Pharmacology Lead in Early- and Late-stage development teams and provide concise, data driven actionable plans and efficiently communicate results and Clinical Pharmacology strategy to development teams.
• Oversee interactions of clinical pharmacology team with other QTR functions, including non-clinical toxicology, DMPK, bioanalytical, and biomarker teams, for design, execution and reporting of clinical studies, especially first-in-human study and clinical pharmacology studies.
• Review business development opportunities and make go/ no-go recommendations on behalf of QTR.

Work with Quantitative Translational Research (QTR) leadership team to set department strategy, growth and cross functional alignment.

• Serve as clinical pharmacology lead on multiple cross-functional project teams; plan and optimize clinical pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages of small or large molecule drugs.
• Review, approve and lead development of clinical pharmacology sections for regulatory filings, including annual reports, investigator’s brochure, IND/NDA/BLA applications and pediatrics development plans in compliance with relevant guidelines and standards.
• Work closely with pharmacometrics team, support model-based drug development (MIDD) strategies, and provide input to PK and PK/PD modeling analysis to support dose selection, efficacy and safety assessments.
• Work closely with Translational and biomarker team, support biomarker development and incorporation into early phase studies.
• Responsible for use of innovative methods of data analysis to integrate knowledge of PK , PD , patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics, biomarker, statistics and clinical development functions (as relevant).
• Review and approve clinical study design and protocols of healthy subject trials (including FIH SAD/MAD, DDI, rBA, mass-balance, HI/RI, TQT,...)
• Interact cross-functionally with other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC. Work with formulation, biomarker and bioanalytical team members on activities related to formulation development, assay development, sample management, Pharmacogenomics (PGx) and biomarker strategy development.

Train and manage junior team members in Quantitative Pharmacology team. Mentor and develop clinical pharmacology talent as the pipeline and organization grow