Clinical pharmacologist job description
Updated March 14, 2024
12 min read
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Example clinical pharmacologist requirements on a job description
Clinical pharmacologist requirements can be divided into technical requirements and required soft skills. The lists below show the most common requirements included in clinical pharmacologist job postings.
Sample clinical pharmacologist requirements
- Advanced degree in Pharmacology, Pharmacy or related field
- Minimum of 3 years of experience in clinical research or clinical pharmacology
- Strong understanding of FDA regulations and drug development process
- Excellent analytical and problem-solving skills
- Ability to interpret and communicate complex scientific data
Sample required clinical pharmacologist soft skills
- Strong communication and interpersonal skills
- Ability to work collaboratively in a team environment
- Excellent time management and organizational skills
- Flexibility and adaptability to changing priorities and timelines
- Commitment to continuous learning and professional development
Clinical pharmacologist job description example 1
Regeneron clinical pharmacologist job description
We are looking for a Clinical Pharmacologist. This individual will plan, design, implement and analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies working with CP, QP, PPK-PD, Toxicology, Bioanalytical, Therapeutic Focus Areas and Clinical Development / Regulatory
Affairs.
We expect this individual to contribute to the scientific understanding of PK/PD for assigned projects, based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs, through the application of pharmacokinetics and pharmacodynamics.
A day in the life of a Principal Clinical Pharmacologist may look like:
* Plans, designs, implements and analyzes routine PMx studies to advance scientific knowledge, in collaboration with other team members.
* Performs analyses such as NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses.
* Works to prepare TFLs to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other documents. Collaborates with Scientific Writing (and where appropriate with PMx Stats Programming team) to ensure TFLs for PMx reports are complete.
Works in conjunction with Scientific Writing, QC and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.
* With close supervision from senior PMx staff, supports preparation of material to be used in regulatory interactions. Preparation of PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings is also in scope. Performs additional analyses as required to support regulatory interactions.
* Participates in technical working groups, providing support for process improvement initiatives.
* Actively publishes work in scientific literature
In order to be considered qualified for this role you must:
Have a minimum of a PhD and experience with PMx concepts and techniques. We expect this experience to include advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods. Experience in Exposure-Response analysis methods, translational modelling/pharmacology, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP are also advantageous.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
#LI-Hybrid
Affairs.
We expect this individual to contribute to the scientific understanding of PK/PD for assigned projects, based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs, through the application of pharmacokinetics and pharmacodynamics.
A day in the life of a Principal Clinical Pharmacologist may look like:
* Plans, designs, implements and analyzes routine PMx studies to advance scientific knowledge, in collaboration with other team members.
* Performs analyses such as NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses.
* Works to prepare TFLs to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other documents. Collaborates with Scientific Writing (and where appropriate with PMx Stats Programming team) to ensure TFLs for PMx reports are complete.
Works in conjunction with Scientific Writing, QC and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.
* With close supervision from senior PMx staff, supports preparation of material to be used in regulatory interactions. Preparation of PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings is also in scope. Performs additional analyses as required to support regulatory interactions.
* Participates in technical working groups, providing support for process improvement initiatives.
* Actively publishes work in scientific literature
In order to be considered qualified for this role you must:
Have a minimum of a PhD and experience with PMx concepts and techniques. We expect this experience to include advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods. Experience in Exposure-Response analysis methods, translational modelling/pharmacology, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP are also advantageous.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
#LI-Hybrid
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Clinical pharmacologist job description example 2
Medpace clinical pharmacologist job description
Responsibilities
- Provide subject matter expertise in the design, conduct, and reporting of clinical trials
- Contribute to clinical pharmacology sections of clinical study protocols, study analysis plans, clinical study reports and clinical development plans
- Lead clinical pharmacology studies and perform PK and PK/PD analyses (e.g., NCA analysis)
- Preparation of standalone PK/PD reports or PK/PD section of Clinical Study Report (CSR)
- Collaborate with biostatistician, clinical operation, bioanalytical scientist and clinician for the execution and management of Phase I-III studies
- Present PK findings and represent clinical pharmacology in cross-functional study team settings
- PhD degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD
- 1-2 years of industry or equivalent experience and working knowledge of analysis software (e.g., WinNonlin, Phoenix NLME and NONMEM) preferred
- Ability to translate pharmacokinetic findings into potential clinical impact is highly desirable
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.
Perks ( vary by location and position ):
- On-site fitness center(s)
- Campus walking paths
- Company-sponsored social and wellness events
- Official Sponsor of FC Cincinnati
- Hybrid work-from-home options and flexible work schedule
- On-site Market Place
- Free and covered parking
- Discounts for local businesses
- On campus restaurants and banks coming soon
Awards:
- Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
- Recognized by Forbes as one of America's Best Mid-size Companies in 2021
- Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets
Dealing with hard-to-fill positions? Let us help.
Clinical pharmacologist job description example 3
Takeda Pharmaceuticals U.S.A., Inc. clinical pharmacologist job description
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Global Head, Quantitative Clinical Pharmacology, in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future_** to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
**POSITION OBJECTIVE:**
+ As Global Head for Quantitative Clinical Pharmacology, the incumbent will have ultimate responsibility for all clinical pharmacology and pharmacometric plans and studies from preclinical translation through registration and commercialization. They will oversee a therapeutically-aligned group of PhD-level clinical pharmacologists who will work with project teams to devise the quantitative clinical pharmacology/pharmacometrics strategy that encompasses both regulatory and innovative considerations to enable getting good drugs to patients faster.
+ They will ensure technical excellence, deep scientific rigor and operational effectiveness within quantitative clinical pharmacology by empowering the clinical pharmacology leads, participating in/leading relevant governance reviews, building external partnerships and collaborations, encouraging publications, working with the Takeda operating model and managing portfolio risks & priorities.
+ They will work collaboratively with the other quantitative disciplines within the Data Sciences Institute to enhance model-informed drug development, trial design and translational sciences, integration of all available data to inform decisions (including clinical trial, literature, real world data, digital streams) bringing the best of quantitative clinical pharmacology and pharmacometrics principles forward.
**POSITION ACCOUNTABILITIES:**
+ Develop, manage and build a world-class quantitative clinical pharmacology organization that has the expertise to span across the entire life cycle, across multiple therapeutic areas, across multiple geographical registrations and across multiple modalities.
+ Develop clear expectations regarding the responsibilities and impact of quantitative clinical pharmacology within Takeda project teams and within the Data Sciences Institute.
+ For preclinical stage assets, work collaboratively with other translational colleagues (preclinical pharmacokinetics and drug metabolism, systems modelling, biology, genetics, clinical sciences etc.) to select appropriate biomarkers and to devise appropriate methods and models for dose prediction, design of first-in-human studies, decision criteria for early clinical studies and integration of available disease/genetic/pharmacokinetic/pharmacodynamic data.
+ For clinical assets, use all available methods, models, data and tools to ensure appropriate dose selection across populations and disease states including (but not limited to) exposure-response modelling, PKPD modelling, longitudinal disease modelling, trial simulations.
+ Collaborate to enable fit-for-purpose model-informed drug development across the life cycle to increase probability of technical success, improve confidence in decision-making, decrease time or decrease patient burden and/or numbers, and assess candidate attributes against available or emerging competitive therapeutics.
+ Responsible for the characterization of the clinical pharmacology profile of early and late stage assets, including phase 1 study responsibility for drug interactions, thorough QT and special populations.
+ Responsible for the integrity and correctness of analysis, interpretation and appropriate integration of clinical pharmacology data from development programs and clinical studies longitudinally and cross-sectionally in support of all regulatory submissions, including global filings.
+ Ensures infrastructure (software, methods, processes, vendors, partners etc.) is efficient and meets all required standards.
+ Manage resources, strategically balancing internal vs external work packages, within budget whilst planning for future needs and capabilities
+ Embraces innovation into clinical pharmacology strategy, including application of advanced analytics (machine learning, artificial intelligence), inclusion of novel data sources (real world data, digital streams, literature-derived data, patient reported outcomes) and development of automation.
+ Serves on senior cross-functional strategic and scientific teams and task forces, providing overall clinical pharmacology expertise where required.
+ Enhances Takeda's reputation externally through scientific leadership and collaboration both within and beyond clinical pharmacology
+ As a member of the leadership team for the Data Sciences Institute, helps drive DSI strategy and accountability across multiple functions ensuring alignment with overall R&D strategy
**EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:**
+ PhD, PharmD, MD, or MD/PhD in a relevant health sciences discipline, with in-depth medical knowledge of physiology, pharmacology, and disease pathophysiology, as well as broad-based knowledge of quantitative clinical pharmacology related areas such as statistics, PK/PD, and systems pharmacology required
+ Recognized leader in the field of quantitative clinical pharmacology and application of computational PK/PD modeling and simulation tools to disease processes and pathophysiology required (as evidenced by publication in peer-reviewed journals)
+ Direct experience with global regulatory submissions and label negotiations.
+ Prior direct experience as Vice President, Executive/Senior Director or other management/leadership positions of Clinical Pharmacology, Pharmacometrics (or similar) in the pharmaceutical industry
+ Minimum 15 years biopharmaceutical/CRO health-related consulting company/academic industry clinical development experience
+ Membership in appropriate professional organizations.
+ Shows cross-cultural understanding to utilize the diverse talents and has demonstrated ability to manage teams to maximize the organizational productivity
+ Has strong leadership skills and acumen.
+ Has excellent written and verbal communication skills
+ Has a proven track record in successfully developing and implementing business strategies.
**Location and Salary Information:**
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy."
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
**WHAT TAKEDA CAN OFFER YOU:**
+ 401(k) with company match and Annual Retirement Contribution Plan
+ Tuition reimbursement
+ Company match of charitable contributions
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs
**Empowering Our People to Shine**
Discover more at **takedajobs.com**
No Phone Calls or Recruiters Please.
\#LI-JV2
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Boston, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Description**
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Global Head, Quantitative Clinical Pharmacology, in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future_** to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
**POSITION OBJECTIVE:**
+ As Global Head for Quantitative Clinical Pharmacology, the incumbent will have ultimate responsibility for all clinical pharmacology and pharmacometric plans and studies from preclinical translation through registration and commercialization. They will oversee a therapeutically-aligned group of PhD-level clinical pharmacologists who will work with project teams to devise the quantitative clinical pharmacology/pharmacometrics strategy that encompasses both regulatory and innovative considerations to enable getting good drugs to patients faster.
+ They will ensure technical excellence, deep scientific rigor and operational effectiveness within quantitative clinical pharmacology by empowering the clinical pharmacology leads, participating in/leading relevant governance reviews, building external partnerships and collaborations, encouraging publications, working with the Takeda operating model and managing portfolio risks & priorities.
+ They will work collaboratively with the other quantitative disciplines within the Data Sciences Institute to enhance model-informed drug development, trial design and translational sciences, integration of all available data to inform decisions (including clinical trial, literature, real world data, digital streams) bringing the best of quantitative clinical pharmacology and pharmacometrics principles forward.
**POSITION ACCOUNTABILITIES:**
+ Develop, manage and build a world-class quantitative clinical pharmacology organization that has the expertise to span across the entire life cycle, across multiple therapeutic areas, across multiple geographical registrations and across multiple modalities.
+ Develop clear expectations regarding the responsibilities and impact of quantitative clinical pharmacology within Takeda project teams and within the Data Sciences Institute.
+ For preclinical stage assets, work collaboratively with other translational colleagues (preclinical pharmacokinetics and drug metabolism, systems modelling, biology, genetics, clinical sciences etc.) to select appropriate biomarkers and to devise appropriate methods and models for dose prediction, design of first-in-human studies, decision criteria for early clinical studies and integration of available disease/genetic/pharmacokinetic/pharmacodynamic data.
+ For clinical assets, use all available methods, models, data and tools to ensure appropriate dose selection across populations and disease states including (but not limited to) exposure-response modelling, PKPD modelling, longitudinal disease modelling, trial simulations.
+ Collaborate to enable fit-for-purpose model-informed drug development across the life cycle to increase probability of technical success, improve confidence in decision-making, decrease time or decrease patient burden and/or numbers, and assess candidate attributes against available or emerging competitive therapeutics.
+ Responsible for the characterization of the clinical pharmacology profile of early and late stage assets, including phase 1 study responsibility for drug interactions, thorough QT and special populations.
+ Responsible for the integrity and correctness of analysis, interpretation and appropriate integration of clinical pharmacology data from development programs and clinical studies longitudinally and cross-sectionally in support of all regulatory submissions, including global filings.
+ Ensures infrastructure (software, methods, processes, vendors, partners etc.) is efficient and meets all required standards.
+ Manage resources, strategically balancing internal vs external work packages, within budget whilst planning for future needs and capabilities
+ Embraces innovation into clinical pharmacology strategy, including application of advanced analytics (machine learning, artificial intelligence), inclusion of novel data sources (real world data, digital streams, literature-derived data, patient reported outcomes) and development of automation.
+ Serves on senior cross-functional strategic and scientific teams and task forces, providing overall clinical pharmacology expertise where required.
+ Enhances Takeda's reputation externally through scientific leadership and collaboration both within and beyond clinical pharmacology
+ As a member of the leadership team for the Data Sciences Institute, helps drive DSI strategy and accountability across multiple functions ensuring alignment with overall R&D strategy
**EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:**
+ PhD, PharmD, MD, or MD/PhD in a relevant health sciences discipline, with in-depth medical knowledge of physiology, pharmacology, and disease pathophysiology, as well as broad-based knowledge of quantitative clinical pharmacology related areas such as statistics, PK/PD, and systems pharmacology required
+ Recognized leader in the field of quantitative clinical pharmacology and application of computational PK/PD modeling and simulation tools to disease processes and pathophysiology required (as evidenced by publication in peer-reviewed journals)
+ Direct experience with global regulatory submissions and label negotiations.
+ Prior direct experience as Vice President, Executive/Senior Director or other management/leadership positions of Clinical Pharmacology, Pharmacometrics (or similar) in the pharmaceutical industry
+ Minimum 15 years biopharmaceutical/CRO health-related consulting company/academic industry clinical development experience
+ Membership in appropriate professional organizations.
+ Shows cross-cultural understanding to utilize the diverse talents and has demonstrated ability to manage teams to maximize the organizational productivity
+ Has strong leadership skills and acumen.
+ Has excellent written and verbal communication skills
+ Has a proven track record in successfully developing and implementing business strategies.
**Location and Salary Information:**
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy."
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
**WHAT TAKEDA CAN OFFER YOU:**
+ 401(k) with company match and Annual Retirement Contribution Plan
+ Tuition reimbursement
+ Company match of charitable contributions
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs
**Empowering Our People to Shine**
Discover more at **takedajobs.com**
No Phone Calls or Recruiters Please.
\#LI-JV2
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Boston, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
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Updated March 14, 2024
Updated March 14, 2024