AD Pharmacometrics
We have a current opportunity for a AD Pharmacometrics on a permanent basis. The position will be based in California or Boston. For further information about this position please apply. Job Summary: The Associate Director of Pharmacometrics will lead the pharmacometrics strategy for clinical programs across multiple indications/ disease areas. This role involves developing and implementing pharmacometric methodologies to address research and development objectives, influencing drug development and adoption decisions, and contributing to regulatory submissions. Key Responsibilities: Provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity. Develop, write, and execute pharmacometrics analysis plans, and deliver comprehensive reports on results. Define and drive pharmacometrics contributions to regulatory/submission strategy and related documents (e.g., briefing books, clinical pharmacology summaries, responses to Health Authority questions). Represent the pharmacometrics function at global regulatory hearings, advisory committee meetings, and other regulatory interfaces. Integrate pharmacometrics information to support drug development milestones and decision boards. Present at various departmental and cross functional teams such as study teams, Clinical Pharmacology leadership team Identify alternative strategic options to mitigate risks in clinical programs. Lead and contribute to integrated evidence generation using disease progression and PKPD modeling techniques with varied data sources, including Real World Data. Ensure alignment of the analytics team (biometrician, data management, database programming, medical and scientific writing) on the pharmacometrics strategy and execution. Qualifications: PhD within Pharmacology, Pharmacokinetics, Pharmaceutics, Data Science, Statistics, or related fields. 5+ years of relevant industry experience in population PKPD analysis. Deep understanding of clinical pharmacology principles and drug development processes. Extensive experience with PK/PD software packages such as NONMEM, Monolix, and R. Strong leadership and project management skills. Excellent communication and presentation skills.. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Opportunities for professional development and career advancement. Flexible working arrangements, including hybrid work options.
US$180000 - US$220000 per year
United States of America
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Senior PK Scientist
About the Role: We are currently representing a dynamic and innovative team at a leading global Clinical Research Organization (CRO) known for its commitment to advancing healthcare through cutting-edge research. We are seeking a highly skilled and experienced Senior PK Scientist to contribute to our groundbreaking projects. Key Responsibilities: Design, analyze, and interpret pharmacokinetic studies to support drug development. Develop and validate PK models to predict drug behavior in various populations. Collaborate with cross-functional teams including clinical pharmacology, bioanalytical, and regulatory affairs. Prepare comprehensive PK study reports and regulatory submissions. Stay updated with the latest advancements in PK and related fields. Qualifications: Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or related field. Minimum of 5 years of experience in PK within the pharmaceutical or CRO industry. Proficiency in PK modeling software (e.g., WinNonlin, NONMEM). Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Why Join Us: Opportunity to work on innovative projects with global impact. Collaborative and supportive work environment. Competitive salary and benefits package. Professional development and career growth opportunities.
US$130000 - US$150000 per year
United States of America
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Associate Director Clinical Pharmacology
Purpose: Conceives, executes, and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD, or regulatory advances, strengths, weaknesses, opportunities, and threats, and responds with appropriate new strategies. Consistently demonstrates an excellent record of accomplishment in Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management. Responsibilities: Accountable for Phase 1-4 studies design and clinical pharmacology strategy; acts as the representative for project(s). Executes strategy, leads teams, and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation, and discussion of model results in the context of research question). Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant sections of investigator brochures, white papers, and other similar documents. Leads clinical pharmacology and biopharmaceutics meetings, serves as Clinical Pharmacology representative at Clinical Strategy Team/Asset Development Team, and presents at various departmental and cross-functional teams such as study teams, Clinical Pharmacology leadership team, and Journal club. Drives small teams with members from Clinical Pharmacology functional groups to provide a unified clinical pharmacology position to clinical, CMC, and regulatory teams. Authors scientific publications and presents at national and international conferences and interacts with KOLs/external stakeholders. Conducts due diligence assessments, summarizes results, and represents Clinical Pharmacology on business development teams. Represents Clinical Pharmacology at regulatory meetings. Qualifications: Ph.D. with typically 4+ years of experience or Pharm.D. with typically 6+ years of experience in a relevant field, Master's Degree or equivalent education and typically 12+ years of experience, Bachelor's Degree or equivalent education and typically 14+ years of experience; (relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters). Excellent interpersonal skills. Ability to interact with functional representatives and KOLs externally and internally and lead team(s). Strategic thinking and enterprise view. Proven scientific track record and technical skills to perform the role. Key Leadership Competencies: Delivers business results while also positioning the company for long-term success. Persistent and resilient; finds the way to move good ideas forward. Acts respectfully yet courageously. Connects unrelated concepts, generates original or unique ideas. Influences colleagues to achieve cross-functional alignment. Gives full accountability when delegating and accepts full accountability when delegated to by others. Uses mistakes, failure, and reflection as vehicles for learning and improvement. What We Offer: Competitive salary and benefits package. Opportunities for professional growth and development. A supportive and inclusive work environment. The chance to make a meaningful impact on the lives of cancer patients.
US$180000 - US$190000 per year + Medical, Dental, Vision, 401K
San Francisco
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Associate Director, Pharmacometrics
Job Title: Associate Director, Pharmacometrics Location: Fully Remote (United States) Position Overview: I'm seeking to connect with highly skilled and motivated Associate Director of Pharmacometrics candidates to join a leading pharma company. This hands-on role will involve leading pharmacometric analyses to support multiple projects. Key Responsibilities: Lead and conduct pharmacometric analyses, including population pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response modeling. Collaborate with cross-functional teams to design and implement model-based drug development strategies. Provide scientific and strategic input to clinical development plans and regulatory submissions. Communicate complex pharmacometric concepts and results to non-experts, including senior management and regulatory agencies. Qualifications: Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacology, Engineering, or a related field. Minimum of 5 years of experience in the pharmaceutical or biotechnology industry. Proven track record of hands-on experience with population PK/PD modeling and simulation. Proficiency in software tools such as NONMEM, R, Monolix, or similar. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills.
US$180000 - US$195000 per year
United States of America
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Manager Pharmacometrics
We have a current opportunity for a Manager Pharmacometrics on a permanent basis. This position will be a hybrid role (3x a week on site). For further information about this position please apply. Job Title: Manager, Pharmacometrics We're representing a leading global pharmaceutical company dedicated to improving health and well-being through innovative medicines and therapies. We are committed to scientific excellence and providing high-quality products to patients worldwide. Job Summary: We are seeking a highly skilled and motivated Manager of Pharmacometrics to join our dynamic team. The successful candidate will lead and manage pharmacometric activities to support drug development programs, ensuring the integration of quantitative modeling and simulation into decision-making processes. Key Responsibilities: Lead the design, execution, and interpretation of pharmacometric analyses to support drug development and regulatory submissions. Develop and implement pharmacometric strategies for various stages of drug development, including preclinical, clinical, and post-marketing phases. Collaborate with cross-functional teams, including clinical pharmacology, biostatistics, regulatory affairs, and therapeutic area experts, to ensure alignment and integration of pharmacometric activities. Provide scientific and strategic input into study design, data analysis, and interpretation of results. Mentor and develop junior pharmacometricians, fostering a culture of scientific excellence and continuous learning. Stay current with advancements in pharmacometrics and related fields, and apply innovative approaches to enhance drug development processes. Prepare and review technical reports, regulatory documents, and publications. Qualifications: Ph.D. or equivalent degree in Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or a related field. Minimum of 4 years of experience in pharmacometrics/(quantitative field) within the pharmaceutical or biotechnology industry. Proven track record of leading pharmacometric analyses and contributing to successful regulatory submissions. Strong knowledge of pharmacokinetic and pharmacodynamic modeling, simulation software (e.g., NONMEM, Monolix, R), and data analysis tools. Pop PK, PK/PD, eposure response modeling Oncology Experience is preferred Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative, multidisciplinary environment. Demonstrated leadership and mentoring abilities. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Opportunities for professional development and career advancement. Flexible work arrangements and a supportive work-life balance.
US$130000 - US$170000 per year
United States of America
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AD Clinical Pharmacology
We have a current opportunity for an AD Clinical Pharmacology on a permanent basis. This is a hybrid position (3x a week onsite) and will be based in Chicago, Illinois or South San Francisco, California. Job Type: Full-Time Department: Clinical Pharmacology Reports To: Director of Clinical Pharmacology Salary: $180,000- $253,500 Job Summary: The Associate Director of Clinical Pharmacology will lead and manage clinical pharmacology activities for drug development programs. This role involves designing and overseeing clinical pharmacology studies, analyzing data, and collaborating with cross-functional teams to support regulatory submissions and clinical development strategies. Key Responsibilities: Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s). Develop and implement clinical pharmacology strategies to support drug development programs. Collaborate with clinical, regulatory, and biostatistics teams to ensure alignment of clinical pharmacology plans with overall development strategies. Provide clinical pharmacology expertise in the preparation of regulatory documents, including INDs, NDAs, and BLAs. Analyze and interpret pharmacokinetic (PK) and pharmacodynamic (PD) data to inform dose selection and optimization. Represent clinical pharmacology in meetings with regulatory agencies and external partners. Mentor and develop junior clinical pharmacology staff. Stay current with scientific and regulatory developments in clinical pharmacology and related fields. Qualifications: PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Master's Degree or equivalent education and typically 12+ years of experience, Bachelor's Degree or equivalent education and typically 14+ years of experience;(*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters) Proven track record of leading clinical pharmacology studies and contributing to regulatory submissions. Strong knowledge of pharmacokinetics, pharmacodynamics, and modeling and simulation techniques. Excellent analytical, problem-solving, and communication skills. Strategic thinking and enterprise view Ability to work effectively in a collaborative, cross-functional team environment. Experience with regulatory interactions and submissions is highly desirable. Preferred Qualifications: Familiarity with population PK/PD modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin). Strong publication record in clinical pharmacology or related fields. Benefits: Competitive salary and bonus structure. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Professional development opportunities. Flexible work arrangements.
US$180000 - US$250000 per year
California
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Director, Clinical Pharmacology
Job Description: As the Director of Clinical Pharmacology, you will play a key role in shaping the clinical pharmacology strategy for our biologics portfolio. You will lead clinical pharmacology teams, collaborate closely with other departments such as regulatory affairs, clinical development, and drug safety, and provide expert guidance on pharmacokinetics, pharmacodynamics, and dosing strategies for our biologic therapies. Key Responsibilities: Lead the clinical pharmacology strategy for biologic products, from early-phase clinical trials through to regulatory submission and approval. Design and implement clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose escalation, and biomarker studies. Analyze and interpret clinical pharmacology data to support decision-making in clinical development and regulatory filings. Collaborate with clinical, regulatory, and non-clinical teams to ensure alignment and timely delivery of program objectives. Provide leadership and mentorship to the clinical pharmacology team, fostering a culture of excellence, innovation, and collaboration. Communicate clinical pharmacology strategies and results to internal stakeholders, regulatory authorities, and external partners. Stay updated with industry trends, regulatory requirements, and scientific advancements in clinical pharmacology and biologics. Qualifications: Advanced degree in Pharmacology, Pharmaceutical Sciences, or a related field (PhD, PharmD, or MD preferred). Minimum of 8-10 years of experience in clinical pharmacology within the biopharmaceutical industry, with a focus on biologics. Strong experience in the design, implementation, and analysis of clinical pharmacology studies for biologic therapies. In-depth understanding of pharmacokinetics, pharmacodynamics, and modeling & simulation techniques. Familiarity with regulatory requirements (FDA, EMA) for biologic products, including clinical trial designs and data submissions. Proven track record of leadership and team management skills. Excellent communication skills and the ability to work cross-functionally in a dynamic, fast-paced environment. Ability to think strategically and contribute to the overall success of the clinical development program.
US$225000 - US$250000 per year
United States of America
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Senior/Principal Pharmacometrician
Job Description: We are seeking a highly skilled and experienced Senior PK/PD Scientist to join our client's dynamic team. The successful candidate will play a critical role in the design, analysis, and interpretation of pharmacokinetic (PK) and pharmacodynamic (PD) studies to support drug development programs. Key Responsibilities: Design and oversee PK/PD studies, including protocol development, data analysis, and interpretation. Develop and validate PK/PD models to predict drug behavior and efficacy. Collaborate with cross-functional teams to integrate PK/PD data into overall drug development strategies. Prepare and present study results to internal teams, clients, and regulatory agencies. Stay current with advancements in PK/PD methodologies and regulatory requirements. Mentor and train junior scientists in PK/PD principles and techniques. Qualifications: Ph.D. in Pharmacokinetics, Pharmacodynamics, Pharmaceutical Sciences, or a related field. Minimum of 5 years of experience in PK/PD modeling and analysis within the pharmaceutical or biotechnology industry. Proficiency in PK/PD software (e.g., NONMEM, Phoenix WinNonlin, Monolix). Strong understanding of regulatory guidelines and requirements for PK/PD studies. Excellent communication and presentation skills. Ability to work collaboratively in a fast-paced, team-oriented environment.
US$180000 - US$220000 per year
United States of America
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Senior PK/PD Scientist
In this role, you will be responsible for designing, conducting, and analyzing complex pharmacokinetic and pharmacodynamic studies to support drug development across various therapeutic areas. You will work closely with cross-functional teams to ensure the success of both preclinical and clinical development programs. Key Responsibilities: Modeling and Simulation: Develop and implement population pharmacokinetic (popPK) and pharmacodynamic (PD) models using advanced modeling and simulation techniques to optimize drug development strategies. Data Analysis and Interpretation: Analyze and interpret PK/PD data, including clinical trial results, and provide insights to guide decision-making for drug development. Collaboration: Work closely with preclinical, clinical, and regulatory teams to support the design, execution, and interpretation of clinical pharmacology studies. Study Design: Contribute to the design of clinical and preclinical studies, including dose escalation studies, clinical trials, and bioavailability assessments, to ensure appropriate study design and data collection. Regulatory Submissions: Prepare and review regulatory submissions, including INDs, NDAs, and other regulatory documents, ensuring that PK/PD data is presented accurately and effectively. Innovation and Methodology: Stay up-to-date with the latest advancements in PK/PD modeling, simulation technologies, and regulatory requirements, applying this knowledge to improve internal processes and modeling techniques. Mentoring and Leadership: Provide guidance and mentorship to junior scientists and contribute to the growth and development of the team's skillset. Qualifications: PhD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or a related field, with at least 5-7 years of industry experience in PK/PD modeling and simulation. Expertise in population pharmacokinetics and pharmacodynamics, including the use of modeling software such as NONMEM, Phoenix WinNonlin, or similar platforms. Strong understanding of clinical pharmacology, including study design, regulatory guidelines, and data interpretation. Experience in applying PK/PD modeling to support drug development across early- to late-stage clinical trials. Excellent communication skills, with the ability to present complex data and concepts to both technical and non-technical audiences.
US$145000 - US$165000 per year
United States of America
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Associate Director Clinical Pharmacology
Position Overview: The role is responsible for leading and managing the design and execution of comprehensive Clinical Pharmacology strategies to meet both commercial and regulatory objectives across multiple functions. This individual will drive the development of pharmacokinetics (PK) and pharmacodynamics (PD) studies, generate new study proposals, and lead the implementation of these strategies. They will also proactively assess advances in clinical pharmacology, PK/PD, and regulatory requirements, identifying strengths, weaknesses, and opportunities, and adjusting strategies as needed. The role ensures alignment between scientific and business objectives, managing clinical pharmacology aspects of various projects. Key Responsibilities: Oversee the design and strategy of Phase 1-4 clinical studies, serving as the primary representative for the project(s). Lead the execution of strategies, guide teams, and provide contextual data analysis and interpretation, including the explanation of mechanisms of action (MoA) and disease-specific data, and discussion of model results in the context of research objectives. Write regulatory documents such as protocols, study reports, population PK reports, exposure-response analysis reports, clinical trial applications (CTAs), and sections for investigator brochures and white papers. Lead clinical pharmacology and biopharmaceutics meetings and serve as the Clinical Pharmacology representative in cross-functional teams, such as Clinical Strategy Teams and Asset Development Teams. Direct small, cross-functional teams to present a unified clinical pharmacology stance to clinical, CMC, and regulatory teams. Publish scientific papers and present findings at national and international conferences, interacting with key opinion leaders (KOLs) and other external stakeholders. Conduct due diligence for potential business opportunities, summarizing findings and representing Clinical Pharmacology in business development teams. Act as the Clinical Pharmacology lead in regulatory meetings, representing the team and driving discussions. Qualifications: PhD with 4+ years of relevant experience, PharmD with 6+ years of experience, or Master's with 12+ years of experience, or Bachelor's with 14+ years of experience in a related field (e.g., PK, PBPK, PK-PD, Pharmacometrics, Drug Metabolism/Transporters). Excellent interpersonal and communication skills, with the ability to interact with internal teams and external KOLs. Strong strategic thinking with an enterprise-wide perspective. Proven scientific and technical expertise in clinical pharmacology and related areas. Leadership Competencies: Drive business results while positioning the organization for long-term success. Resilient and persistent in advancing innovative ideas. Demonstrates courage and respect in decision-making and interactions. Connects diverse ideas and fosters creativity and innovation. Leads by influencing teams to achieve cross-functional alignment. Demonstrates full accountability, both when delegating and being delegated to.
Up to US$190000 per year + Medical, Dental, Vision, 401K
South San Francisco
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Associate Director Clinical Pharmacology
Position Overview: The role is responsible for leading and managing the design and execution of comprehensive Clinical Pharmacology strategies to meet both commercial and regulatory objectives across multiple functions. This individual will drive the development of pharmacokinetics (PK) and pharmacodynamics (PD) studies, generate new study proposals, and lead the implementation of these strategies. They will also proactively assess advances in clinical pharmacology, PK/PD, and regulatory requirements, identifying strengths, weaknesses, and opportunities, and adjusting strategies as needed. The role ensures alignment between scientific and business objectives, managing clinical pharmacology aspects of various projects. Key Responsibilities: Oversee the design and strategy of Phase 1-4 clinical studies, serving as the primary representative for the project(s). Lead the execution of strategies, guide teams, and provide contextual data analysis and interpretation, including the explanation of mechanisms of action (MoA) and disease-specific data, and discussion of model results in the context of research objectives. Write regulatory documents such as protocols, study reports, population PK reports, exposure-response analysis reports, clinical trial applications (CTAs), and sections for investigator brochures and white papers. Lead clinical pharmacology and biopharmaceutics meetings and serve as the Clinical Pharmacology representative in cross-functional teams, such as Clinical Strategy Teams and Asset Development Teams. Direct small, cross-functional teams to present a unified clinical pharmacology stance to clinical, CMC, and regulatory teams. Publish scientific papers and present findings at national and international conferences, interacting with key opinion leaders (KOLs) and other external stakeholders. Conduct due diligence for potential business opportunities, summarizing findings and representing Clinical Pharmacology in business development teams. Act as the Clinical Pharmacology lead in regulatory meetings, representing the team and driving discussions. Qualifications: PhD with 4+ years of relevant experience, PharmD with 6+ years of experience, or Master's with 12+ years of experience, or Bachelor's with 14+ years of experience in a related field (e.g., PK, PBPK, PK-PD, Pharmacometrics, Drug Metabolism/Transporters). Excellent interpersonal and communication skills, with the ability to interact with internal teams and external KOLs. Strong strategic thinking with an enterprise-wide perspective. Proven scientific and technical expertise in clinical pharmacology and related areas. Leadership Competencies: Drive business results while positioning the organization for long-term success. Resilient and persistent in advancing innovative ideas. Demonstrates courage and respect in decision-making and interactions. Connects diverse ideas and fosters creativity and innovation. Leads by influencing teams to achieve cross-functional alignment. Demonstrates full accountability, both when delegating and being delegated to.
Up to US$170000 per year + Medical, Dental, Vision, 401K
Chicago Heights
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Associate Director Clinical Pharmacology
Position Overview: The role is responsible for leading and managing the design and execution of comprehensive Clinical Pharmacology strategies to meet both commercial and regulatory objectives across multiple functions. This individual will drive the development of pharmacokinetics (PK) and pharmacodynamics (PD) studies, generate new study proposals, and lead the implementation of these strategies. They will also proactively assess advances in clinical pharmacology, PK/PD, and regulatory requirements, identifying strengths, weaknesses, and opportunities, and adjusting strategies as needed. The role ensures alignment between scientific and business objectives, managing clinical pharmacology aspects of various projects. Key Responsibilities: Oversee the design and strategy of Phase 1-4 clinical studies, serving as the primary representative for the project(s). Lead the execution of strategies, guide teams, and provide contextual data analysis and interpretation, including the explanation of mechanisms of action (MoA) and disease-specific data, and discussion of model results in the context of research objectives. Write regulatory documents such as protocols, study reports, population PK reports, exposure-response analysis reports, clinical trial applications (CTAs), and sections for investigator brochures and white papers. Lead clinical pharmacology and biopharmaceutics meetings and serve as the Clinical Pharmacology representative in cross-functional teams, such as Clinical Strategy Teams and Asset Development Teams. Direct small, cross-functional teams to present a unified clinical pharmacology stance to clinical, CMC, and regulatory teams. Publish scientific papers and present findings at national and international conferences, interacting with key opinion leaders (KOLs) and other external stakeholders. Conduct due diligence for potential business opportunities, summarizing findings and representing Clinical Pharmacology in business development teams. Act as the Clinical Pharmacology lead in regulatory meetings, representing the team and driving discussions. Qualifications: PhD with 4+ years of relevant experience, PharmD with 6+ years of experience, or Master's with 12+ years of experience, or Bachelor's with 14+ years of experience in a related field (e.g., PK, PBPK, PK-PD, Pharmacometrics, Drug Metabolism/Transporters). Excellent interpersonal and communication skills, with the ability to interact with internal teams and external KOLs. Strong strategic thinking with an enterprise-wide perspective. Proven scientific and technical expertise in clinical pharmacology and related areas. Leadership Competencies: Drive business results while positioning the organization for long-term success. Resilient and persistent in advancing innovative ideas. Demonstrates courage and respect in decision-making and interactions. Connects diverse ideas and fosters creativity and innovation. Leads by influencing teams to achieve cross-functional alignment. Demonstrates full accountability, both when delegating and being delegated to.
US$180000 - US$190000 per year + Medical, Dental, Vision, 401K
South San Francisco
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