Pharma People
AD/Director Clinical Pharmacology
Pharma People, Boston, Massachusetts, us, 02298
Overview:
We are looking for an experienced Associate Director/Director of Clinical Pharmacology with (mAb) and Autoimmune Disease experience to join our clients dynamic team. This role involves providing strategic and scientific expertise within the Clinical Pharmacology (CP) group, supporting cross-functional clinical development efforts, and collaborating with various stakeholders. The position will be pivotal in supporting new and ongoing clinical programs, offering a unique opportunity to contribute to the growth of a biotech environment.Main Responsibilities:Develop and oversee comprehensive CP strategic development plans for assigned clinical programs and studies.Serve as the CP subject matter expert within the clinical study and development teams.Create and finalize CP-related report templates, as well as data handling and analysis standard operating procedures (SOPs).Participate in the creation, review, and finalization of clinical study protocols and statistical analysis plans (SAPs).Supervise and perform pharmacokinetic/pharmacodynamic (PKPD) analyses.Draft, review, and finalize CP study reports and publications, collaborating with Medical Writers to integrate PKPD sections into clinical study reports (CSRs).Collaborate with Regulatory teams to provide CP support for regulatory documents, communications, and presentations, including INDs, health authority inquiries, and BLA summaries.Work with Quantitative Pharmacology (QP) colleagues to develop and implement quantitative strategies for development plans.Assist various functions such as Statistics, Data Management, Clinical, Preclinical/Nonclinical, and Bioassay as needed.Qualifications:Advanced degree (PhD, PharmD, or MD) with training in Clinical Pharmacology, PKPD, Pharmacology, or Pharmaceutical Sciences.Over 5 years of experience in Clinical Pharmacology within drug development in the healthcare sector.Expertise in PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection.Proficient in using pharmacometric (PMx) tools and software (e.g., WinNonlin, NONMEM, and R) for individual and population PK analysis, modeling, and simulations.Previous experience with monoclonal antibody (mAb) therapeutics in autoimmune diseases is preferred.Strong knowledge of current clinical development practices, regulatory requirements, bioanalysis, biopharmaceutics, pharmacology, toxicology, and formulation development.Exceptional written and verbal communication skills with keen attention to detail.Enthusiastic about working in a fast-paced, innovative, and entrepreneurial environment.A collaborative team player who thrives in a cross-functional team setting.Work Environment:Remote-based position.Fast-paced, dynamic, and entrepreneurial atmosphere.Occasional domestic or international travel (up to 10%).
We are looking for an experienced Associate Director/Director of Clinical Pharmacology with (mAb) and Autoimmune Disease experience to join our clients dynamic team. This role involves providing strategic and scientific expertise within the Clinical Pharmacology (CP) group, supporting cross-functional clinical development efforts, and collaborating with various stakeholders. The position will be pivotal in supporting new and ongoing clinical programs, offering a unique opportunity to contribute to the growth of a biotech environment.Main Responsibilities:Develop and oversee comprehensive CP strategic development plans for assigned clinical programs and studies.Serve as the CP subject matter expert within the clinical study and development teams.Create and finalize CP-related report templates, as well as data handling and analysis standard operating procedures (SOPs).Participate in the creation, review, and finalization of clinical study protocols and statistical analysis plans (SAPs).Supervise and perform pharmacokinetic/pharmacodynamic (PKPD) analyses.Draft, review, and finalize CP study reports and publications, collaborating with Medical Writers to integrate PKPD sections into clinical study reports (CSRs).Collaborate with Regulatory teams to provide CP support for regulatory documents, communications, and presentations, including INDs, health authority inquiries, and BLA summaries.Work with Quantitative Pharmacology (QP) colleagues to develop and implement quantitative strategies for development plans.Assist various functions such as Statistics, Data Management, Clinical, Preclinical/Nonclinical, and Bioassay as needed.Qualifications:Advanced degree (PhD, PharmD, or MD) with training in Clinical Pharmacology, PKPD, Pharmacology, or Pharmaceutical Sciences.Over 5 years of experience in Clinical Pharmacology within drug development in the healthcare sector.Expertise in PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection.Proficient in using pharmacometric (PMx) tools and software (e.g., WinNonlin, NONMEM, and R) for individual and population PK analysis, modeling, and simulations.Previous experience with monoclonal antibody (mAb) therapeutics in autoimmune diseases is preferred.Strong knowledge of current clinical development practices, regulatory requirements, bioanalysis, biopharmaceutics, pharmacology, toxicology, and formulation development.Exceptional written and verbal communication skills with keen attention to detail.Enthusiastic about working in a fast-paced, innovative, and entrepreneurial environment.A collaborative team player who thrives in a cross-functional team setting.Work Environment:Remote-based position.Fast-paced, dynamic, and entrepreneurial atmosphere.Occasional domestic or international travel (up to 10%).