Clinical Pharmacologist Resume
Headline : Highly qualified Clinical Pharmacologist. Experienced with oncology drug development, pediatric indications and hospital pharmacy. Experienced in Regulatory Agency, Pharmaceutical Industry or Pharmacy.
Skills : Environmental health and safety, Scientific knowledge.
Description :
- Provided input on PK sampling schedules, drug interaction risk assessment, and concomitant medications in close collaboration with DMPK and bioanalysis team.
- Worked closely with Medical Monitor, Safety Physician, DMPK, Translational Sciences, Biometrics and other functions to ensure accurate interpretation of clinical data and the selection of the right dose for the right patients.
- Addressed ad-hoc questions from Medical Monitor, Investigators, and Regulatory Agencies.
- Led the design and execution of dedicated clinical pharmacology studies (e.g., relative bioavailability, drug interaction) in healthy subjects and patients.
- Independently conducted preliminary PK analyses (i.e., NCA) using Phoenix WinNonlin and present the results with summary statistics and figures.
- Contributed to the oversight of the population PK, exposure-response and other quantitative analyses conducted by vendors.
- Contributed to the discussion with Health Authorities in support of INDs and NDAs.
Experience
5-7 Years
Level
Senior
Education
Ph.D. In Pharmacology
Pharmacologist Resume
Summary : As a Pharmacologist, experienced in PKPD, clinical pharmacology, and pharmacometrics. Experience in cell and gene-based therapeutics with evidence of impact. Worked in a highly collaborative, multi-disciplinary team setting.
Skills : Research, Communication, Scientific knowledge,.
Description :
- Contributed to the publication of Clinical Pharmacology study results on peer-reviewed journals as the lead author or coauthors.
- As a member of clinical study team, involved in reviewing study documents.
- Applied state-of-the art scientific principles and regulatory guidelines in the field of clinical pharmacology and pediatric drug development to advance the development of Day One assets.
- Supported clinical pharmacology function for clinical development of both gene and cell-based therapeutics and act as clinical pharmacology subject matter expert on multidisciplinary teams.
- Studied design and data interpretation of clinical pharmacology studies, including pharmacokinetics, pharmacodynamics, biomarker (PD and safety) and special population studies.
- Conducted non-compartmental and population PK, PK/PD, and exposure-response analysis to support key program decision-making.
- Authored clinical and regulatory documents related to clinical pharmacology components, including protocols, investigator brochures, study reports, briefing documents for regulatory meetings, and NDA/BLA; author scientific publications.
Experience
10+ Years
Level
Management
Education
Bachelor's In Biological Sciences
Senior Pharmacologist Resume
Summary : As a Senior Pharmacologist, planned, designed, implemented and analyzed in-vivo and in-vitro pharmacokinetic, pharmacodynamic studies. Worked with CP, QP, PPK-PD, Toxicology, Bioanalytical, Therapeutic Focus areas and Clinical Development / Regulatory.
Skills : Laboratory, Attention to detail, Adaptability.
Description :
- Represented clinical pharmacology in regulatory interactions.
- Presented scientific results to internal and external stakeholders.
- Collaborated with toxicologist and preclinical pharmacology scientists to design, conduct, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-man studies.
- Worked closely with collaborators and CROs in study protocol/report review for both preclinical and clinical studies
- Engaged and effectively influenced team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
- Drove curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment.
- Managed a small team that includes innate ability to assess talent that will help grow the organization, engaged in crucial conversations by providing and receiving feedback supporting the growth and development of team members.
Experience
7-10 Years
Level
Senior
Education
Bachelor's Degree In Chemistry
Associate Pharmacologist Resume
Summary : As an Associate Pharmacologist, Translated pharmacokinetic finding into potential clinical impact is highly desirable. Communicated, interacted and presented competently and professionally both verbally and writing of all levels within a broad.
Skills : WinNonlin, Phoenix NLME and NONMEM.
Description :
- Planned, designed, implemented and analyzed routine PMx studies to advance scientific knowledge, in collaboration with other team members.
- Performed analyses such as NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses.
- Worked to prepare TFLs to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other documents.
- Collaborated with Scientific Writing (and where appropriate with PMx Stats Programming team) to ensure TFLs for PMx reports are completed.
- Supported preparation of material to be used in regulatory interactions. Prepared PMx materials for regulatory background packages. Performed additional analyses as required to support regulatory interactions.
- Worked in conjunction with Scientific Writing, QC and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.
- Actively published work in scientific literature.
Experience
10+ Years
Level
Management
Education
Bachelor's In Biological Sciences
Assistant Pharmacologist Resume
Objective : As an Assistant Pharmacologist, contributed in scientific understanding of PK/PD for assigned projects, based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs.
Skills : NCA analysis, R, NONMEM.
Description :
- Proficient in mathematical modeling and programming as demonstrated by hands-on experience in computational tools.
- Provided subject matter expertise in the design, conduct, and reporting of clinical trials.
- Contributed to clinical pharmacology sections of clinical study protocols, study analysis plans, clinical study reports and clinical development plans.
- Led clinical pharmacology studies and perform PK and PK/PD analyses.
- Prepared of standalone PK/PD reports or PK/PD section of Clinical Study Report.
- Collaborated with biostatistician, clinical operation, bioanalytical scientist and clinician for the execution and management of Phase I-III studies.
- Presented PK findings and represent clinical pharmacology in cross-functional study team settings.
Experience
2-5 Years
Level
Junior
Education
Bachelor's In Chemistry
Pharmacologist Resume
Headline : As a Pharmacologist, experienced in drug development in the pharmaceutical and biotech industry, covered early phase of development. Interpreted PK, PK/PD and popPK results.
Skills : Time management, Collaboration, Adaptability.
Description :
- Represented the department and provide subject matter expertise on cross-functional teams.
- Designed Phase I and Phase IIa clinical studies, including dose escalation, drug-drug interactions, mass balance, TQT and special population studies.
- Provided input on clinical study designs at later stages of development.
- Authorized and reviewed clinical pharmacology aspects of all clinical studies, clinical protocols, analysis plans and study reports.
- Conducted PK and PK/PD analyses using Phoenix WinNonlin.
- Operated within the time and budget constraints of the clinical program.
- Communicated project-related information, including the planning and execution of meetings and presentations.
Experience
5-7 Years
Level
Senior
Education
Bachelor's In Statistics
Pharmacologist Resume
Objective : As a Pharmacologist, Experienced in clinical and managerial areas. Attended and participated Medical Board, Chief of Service, and clinical sectional meetings to give progress reports and provide educational services to the Medical Staff.
Skills : Planning, Co-ordinational Skills.
Description :
Worked in conjunction with the Medical Staff and the Director of Pharmacy Services, developed, maintained, and coordinated the clinical services offered by Pharmacy to support the appropriate utilization of drug therapy and rational pharmaceutical care.
Coordinated and developed the Medication use evaluation activities and PI, as well as educational activities for the Pharmacy and hospital staff (especially the Medical and Nursing Staff), and provides patient education as necessary.
Ensured all activities conducted in accordance with regulatory, legal and accreditation agency requirements.
Travel up to 20% as necessary according to project needs.
Coordinated the academic and education programs, including residency, graduate clinical rotations and undergraduate students.
Conducted a clinical pharmacy practice at the facility and fosters an environment that provides direction and encouragement for other qualified individuals to develop a clinical pharmacy practice.
Actively participated in the Medical Board, Chiefs of Service Meeting and Sub-sectional Clinical Meetings to promote rational pharmaceutical care.
Experience
2-5 Years
Level
Junior
Education
Bachelor's In Chemistry
Pharmacologist Resume
Summary : As a Pharmacologist, Carried out all activities according to appropriate LabCorp SOPs, worked within the framework of the Quality Management System and to GCP. Contributed to review and amendment of departmental processes and supporting documentation. Provided PK input into other disciplines activities and participate in interdepartmental processes.
Skills : Data Analysis, Clinical Skills.
Description :
- Designed and planned in vivo pharmacology studies for CRO clients.
- Delivered high quality data and supporting documentation.
- Expanded the portfolio of technologies within the micro dialysis area.
- Maintained awareness of emerging literature and science in PK/Clinical Pharmacology specific to eyecare, aesthetics, and neurotoxin.
- Designed and provided scientific oversight of preclinical PK/TK studies and Clinical Pharmacology studies.
- Conducted data analyses including PK/PKPD analyses, modeling and simulation, literature data analyses.
- Liaised with research, toxicology, immunology, bioanalytical, clinical development, and regulatory colleagues to generate data and knowledge supporting product development and implementation of translational models.
Experience
7-10 Years
Level
Senior
Education
Bachelor's In Pharmacology
Pharmacologist Resume
Summary : As a Pharmacologist, experienced in pharmacometrics and clinical pharmacology. Knowledge on software tools-Clinical Trial Management Systems, Drug Interaction Checkers, Pharmacokinetic (PK) modeling software, Statistical Analysis Software. Analyzed pharmacometrics data and applying pharmacometrics in drug development.
Skills : Phoenix, NONMEM, Pharmacokinetic (PK) modeling software
Description :
- Prepared scientific and medical reviews of substances for scheduling actions for substances or drugs, based on the abuse potential of the substances and law enforcement data.
- Scheduled actions are initiated by the Food and Drug Administration, DEA, or from petitions from the public.
- Promoted model-informed drug discovery and development through external collaboration, journal publication and conference presentation
- Established and maintained effective collaborations with key stakeholders.
- Facilitated data integration for biomarker selection, candidate nomination/selection, human dose prediction and FIH study design, and late-stage clinical development dose selection and clinical pharmacology characterization to support registration and product labeling.
- Participated and presented at various departmental and cross functional teams.
- Authored regulatory documents including protocols, study reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, and other similar documents.
Experience
10+ Years
Level
Executive
Education
Bachelor's In Statistics
Pharmacologist Resume
Summary : As a Pharmacologist, Worked within multidisciplinary team medical physicists, radiologists, nuclear medicine physicians, pharmacologists, oncologists, radiation oncologists, towards the overall aim of enabling personalized radiopharmaceutical therapy and precision dosimetry.
Skills : Therapy Assistant, Analyzing.
Description :
- Worked with PC based applications and software and ability to utilize same in monitoring and intervening to promote rational medication use.
- Evaluated the safety and efficacy of active ingredients in over-the-counter products.
- Collaborated with researchers, clinicians and imaging experts from UBC, BCCRI, NIH, and our industry partners.
- Reviewed draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK(/PD) analysis and study objectives.
- Conducted or reviewed/QC interim PK(/PD) analyses, interpret the data, and attend dose escalation teleconferences to support dose progression in allocated studies.
- Conducted or reviewed/QC non-compartmental PK and PD analyses as specified in the report and analysis plans.
- Knowledge on designing and planning PK-focused clinical investigations.
Experience
10+ Years
Level
Executive
Education
Bachelor's In Pharmacology
