Clinical Pharmacology Resume Sample
Laurel Stanton
485 Schmitt Pines,
Chicago,
IL
+1 (555) 862 5314
Work Experience
Associate Director, Clinical Pharmacology
07/2015
-
PRESENT
Dallas, TX
- The production of study related documents such as, but not limited to synopses/protocols and Informed Consent Documents
- Responding to issues raised in audits (R&D QA or Compliance)
- All elements of a clinical pharmacology end-to-end cross functional, integrated asset plan to include scope, budget, timeline, resources, and risks that translate the strategy into operational objectives in close partnership with the Clinical Pharmacologist
- Monitoring performance vs. plan and leading appropriate control processes
- Implementation, application, and integration of Next Generation Development (NGD) mindset and processes into the clinical pharmacology asset level plans and challenging the status quo to speed quality medicines to patients
- Planning and operational input into discovery biomarker and platform validation opportunities
- All post submission regulatory interactions in regards to the safety information, responses and post-approval commitments made, in addition to long-term NILEX support for the compound
- Collaborating with their cross-functional partners and teams to lead the planning and delivery of an asset strategy and executable plan
Quantitative Clinical Pharmacology
11/2011
-
05/2015
Chicago, IL
- Provide functional input in to the early development plan
- Provides strategic clinical programs input to GDT
- Provides reports on programs/studies overseeing, related activities and milestones
- Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission. Support preparation of high-level plan for phase 2 and 3 studies for initial entry into the clinic to post launch support
- Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies (e.g. TQT studies)
- Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug-disease response models
- Contribute, as an integral member of the Clinical Pharmacology team, to global alignment of Phase I and II clinical studies as well as submission planning activities
- Review and prepare documents for regulatory submission including clinical development plans, Investigator’s Brochure and the Clinical Pharmacology section of INDs, CTAs and/or NDAs. Review/prepare responses to inquiries and represent Clinical Pharmacology group at any meetings with regulatory authorities
- Demonstrated accomplishments in modeling analysis, experimental design, regulatory considerations and execution of clinical PK/PD studies
Clinical Pharmacology Fall Internship
06/2008
-
07/2011
New York, NY
- Serve as the single point of operational contact for cross-functional partners and teams
- Leading and influencing upward, on point for cross-functional communications, risk/mitigation activities
- Ensuring documentation of key clinical information and decisions, as well as real-time accuracy of project management and clinical systems (MS Project, SAP, Planisware, IMPACT, etc )
- Creates study level documents that include, but is not limited to synopses, protocols, and Informed Consent Documents
- Contributes to and manages the contributions from applicable study team members (i.e., project physician, statistician, and pharmacokineticist) to the protocol
- Oversees and monitors/manages assigned studies according to the Clinical Monitoring Plan Monitoring for onsite data review, data clarification resolution, and drug accountability
- Conducts regular investigator site contacts that include but are not limited to routine monitoring visits, Site Selection, Site Initiation, Observation, Interim and Close-out Visits
- Monitors safety through but is not limited to telephone contacts, study event reports, case report forms/safety report reviews, monitoring trip reports, or direct site visits
- Acts as the primary point of contact for the study (this includes both internal and external contacts) and reports key study performance information including study start-up, enrollment, adverse events, and closeout
Education
Georgia State University
2003 - 2007
Science's Degree in Pharmaceutical Sciences
Professional Skills
- Strong interpersonal skills including excellent time management, decision-making, presentation skills, and human relations skills
- Excellent writing and verbal communication skills and experience in regulatory interactions
- Excellent communicator with strong interpersonal skills and possess the ability to work collaboratively and independently
- Excellent computing and IT skills
- Strong PK/PD skills, extensive knowledge of pharmacokinetic concepts, DMPK knowledge and pharmacokinetic analysis software (e.g., Phoenix WinNonlin)
- Demonstrated ability to work effectively in a matrix, team environment, manage multiple priorities and exercise sound judgment
- Experience or demonstrated aptitude in the application of clinical pharmacology, modelling and simulation methodologies to drug development
How to write Clinical Pharmacology Resume
Clinical Pharmacology role is responsible for modeling, research, analysis, software, regulatory, training, integration, database, oncology, reporting.
To write great resume for clinical pharmacology job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Pharmacology Resume
The section contact information is important in your clinical pharmacology resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Pharmacology Resume
The section work experience is an essential part of your clinical pharmacology resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical pharmacology responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical pharmacology position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Pharmacology resume experience can include:
- Working knowledge of standard PK/PK-PD software with experience in the application of non-compartmental analyses to drug development
- Experience interacting with regulatory agencies including being directly involved in the review process
- Experience with applications of population PK/PD, modeling and simulation and model-based drug development into clinical development plans
- Consult on clinical trial design scenarios prior to a study manager being assigned
- Identifying and managing consultants and vendors supporting clinical pharmacology
- Identifying and managing consultants and vendors supporting clinical pharmacology studies
Education on a Clinical Pharmacology Resume
Make sure to make education a priority on your clinical pharmacology resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical pharmacology experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Pharmacology Resume
When listing skills on your clinical pharmacology resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical pharmacology skills:
- Good written and oral communication skills (communication)
- Good drug development experience for both small and large molecules is required
- Strong knowledge and experience in nonlinear mixed-effect modeling methodology
- Working knowledge in model building, diagnostic and validation methods
- Experience with clinical trial simulation to derive operating characteristics of study and program designs is highly desirable
- Has a solid understanding of pharmacacological, physiological and biochemical effects of drugs (biologics, proteins and small molecules)
List of Typical Experience For a Clinical Pharmacology Resume
1
Experience For Associate Director, Clinical Pharmacology Resume
- Strong data analytic skills and an in-depth knowledge of pharmacokinetic and pharmacodynamics principles, including their applications in clinical research and drug development
- Director: 7-10 years of experience in pharmaceutical or biotechnology industry with a broad and proven understanding of drug development
- Experience preparing regulatory documents from IND through NDA, with prior direct involvement with successful major regulatory filings
- Experience leading matrixed teams and/or direct reports
- Ensuring the integration of Clinical Pharmacology Modeling and Simulation plans into overall Project and Clinical Development plans and strategies
2
Experience For Validation Lead-clinical Pharmacology Unit Resume
- Play a central role in predicting human dose range, characterising dose-response relationship and justifying dose recommendations for special populations
- Comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines
- Contribute to and provide leadership for the Department’s mission to advance the science of Clinical Pharmacology through publications, active involvement and leadership in external scientific societies and industry consortia, and collaborations with external partners
- Work with internal and external resources (outsourcing & expert consultants) to execute investigation plan
- Expertise in providing CRO and consultant oversight
3
Experience For Manager, Clinical Pharmacology Resume
- Produces independent writing for publications & regulatory documents; participates in KOL and regulatory interactions with supervision
- Prepare the clinical pharmacology components of regulatory documents and responses such that GSK products are approved with optimum labelling
- Design clinical pharmacology/PK programs to support the development, registration and commercialization of Shire’s products
- Design and implement pharmacology strategy and studies (in vitro & in vivo) for drug candidates in development
- Communicate findings to scientific and non-scientific audiences
4
Experience For Clinical Pharmacology Operations Research Associate Resume
- Provide input on pharmacological aspects for new candidates either internal or external (via due diligence,)
- Support and write regulatory submissions/interactions
- Support scientific discussions, communications and publications (self and third party initiated)
- Severe as a liaison across sites ( local units, e.g discovery and the team in Israel)
- Provide the PK/PD sections of clinical protocols, clinical study reports, Investigator’s Brochures, Health Authority Briefing Books, IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) applications, CTD (Common Technical Document) summaries, and any other relevant. document for Health Authority submissions
- Establishment of Clinical Pharmacology expertise within Sandoz Biopharm
- High quality contributions to submissions
- Serve as a consultant for scientific and therapeutic knowledge of clinical trial process across assets within the Neuroscience therapeutic area
5
Experience For Quantitative Clinical Pharmacology Resume
- Explore new areas of research development within the the Neuroscience therapeutic area
- Responsible for developing strategic and collaborative partnerships with senior CP&P leaders. Trusted partner to CP&P leadership, and works closely with them to ensure that IT fully supports CP&P’s scientific mission
- A highly effective communicator who can clearly summarize information and collaborate with others
- Ph.D. in a Pharmaceutical Science, Pharmacology or related field such as Bioengineering with an emphasis in PK/PD modeling
- Assists and/or participates in planning and conduct of investigator’s meetings, monitoring visits, Site Selection, Site Initiation, Observation, Interim and Close-out Visits
- Protocol design, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans
- Collaborating with early development colleagues on the scientific/technical aspects of assigned studies from conception through final report, including protocol development, budget (as appropriate), timelines, sample handling/processing, bioanalysis (through CRO), and PK data analysis/interpretation
- Representing Jazz in interactions with regulatory agencies and responding to regulatory inquires related to DMPK, PKPD, and clinical pharmacology
- Participation on cross functional teams as early development sciences expert to insure proper integration of these activities into overall project plans
6
Experience For Senior Director, Clinical Pharmacology Resume
- Participating in the evaluation of potential in-licensing candidates. Serve as early development sciences expert representative on teams evaluating candidates for in-licensing or risk sharing opportunities
- Embody and model Jazz core values
- Responsible for all aspects of Phase 1 studies and logistical aspects of Phase 2-3 studies related to clinical pharmacology independently; supports Phase 2/3 clinical pharmacology objectives with supervision
- Serves as specialist in and can conduct technical Pop PK-PD analyses (phases 1 – 2)
- Interacts with study and project team members, interfaces with TMCP counterparts in other regions and oversees outside vendors
- Mentors and serves development role for new juniors/new employees
- Research and report on clinical pharmacology topics such as pathophysiology of diseases, dose optimization strategy, influence of intrinsic and extrinsic factors on PK/PD, and drug-drug interactions
- Compile biology, pharmacology, toxicology, and biomarker data to characterize and compare compounds in development to those from marketed drugs
7
Experience For Manager Non-clinical Pharmacology Global Regulatory Affairs Resume
- Collaborate with external networks (eg, academia, consortia and CROs), and keep up to date with emerging literature and regulatory guidance documents in the field of clinical pharmacology
- Upper classmen undergraduate student enrolled in a Pharmacology or Toxicology program or a related field; or a graduate student enrolled in at least the third year of a Pharmacy program or a related field
- Skilled at data analysis and scientific literature research
- Act as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary study team for a late-stage immuno-oncology program
- Able to analyze pharmacokinetic data and integrate this knowledge into the clinical trials and the overall clinical program
- Draft clinical pharmacology components of protocols, clinical development plans and regulatory documents
- Assist in the leadership of the Clinical Pharmacology Department, and directly manage other CP professionals
- Develop and maintain comprehensive clinical pharmacology strategic development plans for assigned development programs
8
Experience For Clinical Pharmacology Manager Resume
- Provide clinical pharmacology subject matter expertise to the Clinical Study Team/ Joint Development Team
- Work closely with Quantitative Pharmacology colleagues to develop and deliver agreed quantitative strategies to support assigned development plans
- Supervise and/or conduct pharmacokinetic / pharmacodynamic analyses
- Draft, finalize, and/or review clinical pharmacology study reports and publications. Work with the Medical Writing Team to incorporate PK/PD sections into clinical study reports
- Assist the Pre-clinical Pharmacokinetic/pharmacodynamics Team as needed
9
Experience For Director, Clinical Pharmacology Resume
- Develop and implement model-based drug development using quantitative approaches to address complex questions which arise during drug development, spanning target validation to analysis and interpretation of Phase 1-3 results
- Assist GCP and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates
- Developing and/or maintaining a strong working knowledge of pharmacology, physiology, clinical pharmacology, therapeutics and pharmacometrics, such that the value of quantitative approaches can be fully exploited
- Lead the design of clinical pharmacology studies or protocol sections as required throughout all stages of drug development and provide oversight for implementation of such studies together with Clinical Development, Clinical Safety and Clinical Research Operations
- Independently plan and implement relevant PK-PD analyses, including non-compartmental analysis of PK data and relevant PK-PD analysis as required
- Provides Clinical Pharmacology expertise to Discovery. During the pre-clinical stages of drug
10
Experience For IT Business Partner for Clinical Pharmacology & Pharmacometrics Resume
- Thorough understanding of GCP and regulatory guidelines
- For a MD, be able to provide medical expertise, input and/or oversight to Clinical Pharmacology studies
- Independently undertake and/or lead the high quality review and interpretation of clinical pharmacology study results and oversees the presentation thereof in clinical study reports, publications and related study documentation
- Independently provide clinical pharmacology & pharmacometrics representation on clinical development matrix teams, ensuring cross-functional alignment and integration of the clinical pharmacology strategy within the global development plan
- Independently implement the use of innovative analytical methods such as pharmacometrics/modeling & simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs throughout an assigned clinical development program
- Represent, with minimal managerial guidance/support, Clinical Pharmacology for market approval submissions to regulatory authorities, authority meetings and answers to all related authority questions
- Be able to provide independent support to Research and Translational Science and in the development of preclinical PK-PD knowledge required for early clinical development strategy, as well as utilizing Pharm-Tox data appropriately in the development of early clinical studies
List of Typical Skills For a Clinical Pharmacology Resume
1
Skills For Associate Director, Clinical Pharmacology Resume
- Significant clinical research experience (6+ years) with evidence of increasing responsibility within a pharmaceutical company or CRO
- Demonstrated strong numeric competency
- Cross-functional leadership experience and supervisory experience
- Work effectively independently and in multi-disciplinary teams, with peers, and with senior management to move projects forward
- Proven record in clinical drug development with experience in oncology
2
Skills For Validation Lead-clinical Pharmacology Unit Resume
- Prior experience with large molecules and/or immuno-oncology or immunology is desirable
- Experience in designing, analysing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate
- Accountable for ensuring that there are valid methods for measuring drug concentration (and
- Good knowledge of PK/PD modeling principles is required
- Hands-on experience with modeling and simulation software (R, NONMEM, Phoenix NLME, Monolix) desirable
3
Skills For Manager, Clinical Pharmacology Resume
- Experience in design, analysis and delivery of PBPK, PK/PD studies and modeling activities
- Build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
- Minimal 8-10 years’ working experience in a regulated environment
- Experience with regulatory submission process (IND, NDA, MAA) desirable
- Work experience within the clinical data management function of a pharmaceutical, biotech or CRO organization
- Experience interacting with regulatory agencies, in particular PMDA
- Experience with authoring regulatory documents
- Relevant experience in clinical pharmacology and modelling and simulation in drug development
- Experience in the design, analysis, interpretation and reporting of clinical pharmacology studies
4
Skills For Clinical Pharmacology Operations Research Associate Resume
- Drug development experience with expertise in early clinical development
- Experience in leadership roles in IT for biopharma R&D, bioinformatics, biostatistics, and/or translational research in academia
- Relevant industry experience (clinical pharmacology and/or clinical PK/PD)
- Industry experience in clinical pharmacology and/or clinical PK/PD and/or
- Academic/industry experience
- Identifying and managing consultants and vendors supporting clinical pharmacology biomarker selection and analyses in order to establish proof of principle
5
Skills For Quantitative Clinical Pharmacology Resume
- Participating in writing publications and making scientific presentations consistent with development strategies and publication plan
- Representing Akebia in interactions with regulatory agencies and responding to regulatory inquires related to DMPK, PKPD, and clinical pharmacology
- Developing and maintaining contact with internal and external scientific experts
- Understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies
- Working knowledge of related FDA/EMA regulations and Guidance documents
- Operating knowledge of suitable computer software, with in depth knowledge of Microsoft Office, especially Excel and PowerPoint
- Understanding of statistical methodologies: ANOVA, hypothesis testing, Bayesian inference, nonlinear mixed-effects modelling
- Working knowledge of formulation development, drug development, PK/PD modeling and simulation
- Understanding of the company’s products and the pharmaceutical industry in general
6
Skills For Senior Director, Clinical Pharmacology Resume
- Responsible for designing and implementing dose finding strategies to ensure optimal dose and dosing regimens in clinical trials
- Able to apply pharmacokinetic and pharmacokinetic-pharmacodynamic concepts, including the modeling and simulation to clinical trial design
- Flexibility to react rapidly to changing situations/environment
- Knowledge of Quantitative Clinical Pharmacology and the application of Modeling & Simulation
- Foster working environment that promotes collaboration, innovation, and creativity
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other
- Successful planning, execution, and analysis of PK and PD components of Biosimilar programs
- Lead and influence during governance meetings and portfolio reviews
- A Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines is required
7
Skills For Manager Non-clinical Pharmacology Global Regulatory Affairs Resume
- Participate in the drafting and finalization of clinical study protocols and study analysis plans (SAP)
- Routine demands of an office based environment
- In-depth knowledge of statistics & broad knowledge in statistical modeling concepts and application, including linear and nonlinear regression modeling, semi-parametric and parametric modeling, logistic regression, generalized linear models and mixed-effects models etc
- Build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
- Multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organizing and time management)
- Actively identifying new areas for learning, and application to the job (continuous learning)
- Self-motivated with the ability to work independently with minimal supervision (personal accountability)
- Interface with people of various groups (e.g., clinical, bioanalytical, data management, etc) and disciplines
- Drug development experience in one or multiple Therapeutic Areas and has the ability to handle contributions to multiple clinical pharmacology programs, simultaneously
8
Skills For Clinical Pharmacology Manager Resume
- Interpret PK and PKPD results and author report sections and prepare presentations to illustrate findings accurately
- Ph.D. in clinical pharmacology, pharmacokinetics and metabolism, pharmacometrics, chemical/biomedical engineering, computational biology/chemistry or a related field with 3+ years’ pharmacetical industry /academic experience
- M.S. in clinical pharmacology, pharmacokinetics and metabolism, pharmacometrics, chemical/biomedical engineering, computational biology/chemistry or a related field or a related field with 5+ years’ industry experience
- Represents QS and Takeda in meetings with regulatory agencies and health authorities if needed
- Provides mentoring in pharmacometric to new staffs and members of other functional areas and collaboratively interacts with scientists from other functional areas, divisions, affiliates and alliance partners
- Represents Takeda at external meetings and conferences as well as establish the reputation of Takeda with the external experts and medical community
- Complete tasks to deadlines and resolve/escalate problems in a timely manner
9
Skills For Director, Clinical Pharmacology Resume
- Participate in user-group meetings and consortia where applicable
- Assist in process improvement initiatives where applicable
- Support GCP and PM Leaders with ad-hoc PM analyses
- A competitive salary and generous social benefits
- The possibility for development and advancement within our dynamic organization
- Ensuring/performing appropriate PKPD analysis including population PK, PKPD modeling and simulation, meta-analysis, mechanistic modelling, disease state modelling as required by the program to aid in data interpretation, trial design and/or program decision-making
- Maintain knowledge of relevant scientific and regulatory practices, guidance and trends, and ensure that clinical pharmacology aspects of development programs are contemporary
- Identify and solve problems while exhibiting superior judgment and a balanced, realistic understanding of issues
- Postgraduate Clinical Pharmacology training
10
Skills For IT Business Partner for Clinical Pharmacology & Pharmacometrics Resume
- Knowledge of regulatory requirements for early clinical development/ clinical pharmacology studies
- Ph.D., M.D./Ph.D., or Pharm.D. in biomedical engineering, applied pharmacology, pharmacokinetics, or a related field with 2+ years of direct industry or post-doc experience in clinical pharmacology and advanced modeling & simulation
- M.S. in biomedical engineering, applied pharmacology, pharmacokinetics, or a related field with 5+ years of direct industry experience in clinical pharmacology and advanced modeling & simulation
- Responsible for impactful strategic scientific input and modeling and simulation (M&S) technical expertise throughout the drug development lifecycle
- Ensure quantitative clinical pharmacology aspects are implemented and completed in a timely manner to enable impactful and high quality decision making
List of Typical Responsibilities For a Clinical Pharmacology Resume
1
Responsibilities For Associate Director, Clinical Pharmacology Resume
- A PhD in Pharmacology/Pharmacy/Biological Sciences with hands on quantitative skills
- Demonstrated ability to write clear, concise technical reports and attention to detail is essential
- Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) for human studies
- Post-graduation experience in a fellowship or industry environment
- PhD, Pharm.D. with 0-5 years of drug development experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
- Assisting in participating in design of the clinical pharmacology component of drug development programs consistent with company and R&D program goals
- Promote clinical pharmacology strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences
2
Responsibilities For Validation Lead-clinical Pharmacology Unit Resume
- Act as a Clinical Pharmacology representative providing clinical pharmacology expertise to a multidisciplinary study team for a late-stage program(s)
- Manage the work, timeline deliverables, and relationship with PK/PD CROs, consultants and collaborators
- Represent Halozyme as a Subject Matter Expert (SME) at conferences and regulatory meetings
- Actively contribute to scientific literature; work with our Global Publications team to develop abstracts and manuscripts
- Enhance professional growth and development through participation in educational programs, current literature, in-service meetings and workshops
- Comply with established company policies and procedures, objectives, quality assurance program, safety and environmental standards
- Serve as the SME for Clinical Pharmacology on Clinical and Development sub- teams as appropriate
- Coordinate with medical writers, clinicians and regulatory representatives in data review and analysis for study reports and submissions (including Investigator Brochures, EOP2 meetings, and relevant sections of INDs or BLAs, etc) as needed
- Significant knowledge and experience in the pharmacokinetic evaluation of parenteral therapeutics, drug metabolism, and protein/drug properties governing in vivo distribution
3
Responsibilities For Manager, Clinical Pharmacology Resume
- Demonstrated history of scientific participation with industry, academia and regulatory agencies
- Manage operational elements of CP studies with respective project GCP leaders
- Support GCP and PM Leaders with ad hoc analyses, not limited to non-compartmental analyses in support of Phase I studies
- Accountable and responsible for the clinical pharmacology deliverables for the assigned projects within sphere of influence
- Responsible for appropriate clinical pharmacology input on project teams and contribution of clinical pharmacology expertise and leadership to a project
4
Responsibilities For Clinical Pharmacology Operations Research Associate Resume
- Responsible for ensuring planning and direction of clinical pharmacology components on the clinical project level (including clinical development plan) and studies (including synopsis preparation, clinical phase oversight, reporting)
- Responsible for implementing clinical pharmacology best practices on project team
- Responsible for ensuring clinical pharmacology leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies
- Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan that conforms with best practices
- Responsible for ensuring use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs
5
Responsibilities For Quantitative Clinical Pharmacology Resume
- Responsible for ensuring appropriate summary and interpreting results of pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs
- During the pre-clinical stages of drug development, works closely with colleagues in other disciplines to ensure that sufficient preclinical PK-PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model
- Provides clinical pharmacology support and leadership in various regulatory interactions
- Influences environment outside of Pfizer through methods such as publication and presentations
- Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development programs and robust registration packages
- Develop mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance
6
Responsibilities For Senior Director, Clinical Pharmacology Resume
- Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
- Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriate
- Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
- Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators
- Innovate through working effectively with colleagues in the department and other matrix team members, including: statisticians, biologists, physicians and drug metabolism scientists
7
Responsibilities For Manager Non-clinical Pharmacology Global Regulatory Affairs Resume
- Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application
- Participate in implementing model-informed drug development using quantitative approaches to address questions arising during drug development (including dose selection, clinical trial design, special population dosing, benefit/risk assessment)
- Clinical Pharmacology leader on one or more project teams across therapeutic modalities, indications, and stages of development (stage -1 to post-marking)
- Analyze and interpret PK and PK/PD data from nonclinical and clinical studies using appropriate quantitative methodologies
- Work closely with clinicians, statisticians, and clinical operations colleagues to design, conduct and report results of Clinical Pharmacology trials
- Accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis, etc
8
Responsibilities For Clinical Pharmacology Manager Resume
- Responsible for providing the clinical pharmacology components of protocols, clinical development plans and regulatory documents
- Able to interpret PK and PK/PD data and integrate this knowledge into the clinical trials and the overall clinical program
- Influences environment outside of Pfizer through methods such as publications and presentations
- Author clinical pharmacology reports/sections of regulatory documents and represent the function at regulatory interactions
- Lead cross-functional process initiatives to improve consistency in deliverables and interactions with internal partners
- Establish and maintain networks of external thought/opinion leaders in the clinical pharmacology field
9
Responsibilities For Director, Clinical Pharmacology Resume
- Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA’s, IB’s, etc.)
- Effective participation on cross functional teams representing early development department to insure integration of modern pharmacology principles into project plans
- Work closely with Bioanalytical Scientists, Project Managers, Clinical Researchers, Biostatisticians and Clinical Trials Managers to support clinical development programs
- Driving the development and execution of the Clinical Pharmacology strategy for small and large molecules in drug development and delivering key components of the Clinical Development Plan
- Providing scientific leadership on Clinical Pharmacology strategy and translational science to cross-functional project teams. Working with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes
- Designing and implementing Clinical Pharmacology studies that allow early go/no-go decisions, incorporate innovative clinical development strategies and support competitive drug labels. Leading the integration of modeling & simulation (PK/PD) and PGx activities in the Clinical Pharmacology programs
10
Responsibilities For IT Business Partner for Clinical Pharmacology & Pharmacometrics Resume
- Serving as a Study Director/Clinical Pharmacology lead and driving the execution of the protocol concept to final report including interpretation of clinical data
- Creating and maintaining internal and external networks to maintain cutting edge knowledge of Clinical Pharmacology approaches and to implement novel designs in the clinical trial
- Representing and leading clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, Type C, NDA meetings. Leading the resolution of clinical pharmacology queries from drug regulatory agencies and taking a lead role in writing and reviewing responses to regulatory queries
- Providing recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and project teams and in regulatory documentation
- Maintaining extensive scientific awareness and presence in Clinical Pharmacology, Publishing multiple manuscripts and posters, and Presenting at Scientific Conferences and other scientific forums
- Together with the Director, develop and maintain comprehensive clinical pharmacology strategic development plans for assigned development programs
- Together with the Director, provide clinical pharmacology subject matter expertise to the Clinical Study Team/ Development Team
- Assist the Pre-clinical PK/PD Team as needed
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Pharmaceutical Representative Resume Sample
Work Experience
• Valid driver’s license with a clean driving record and ability to pass a complete background check
• Allocate resources in
• Report to Touchpoint National Sales Director
• Work closely with Touchpoint Client Services and members of Touchpoint home offic...
Professional Skills
• Successful inside/outside pharmaceutical s...
• Ales and/or marketing experience
• Identify critical activities and tasks and...