Director Pharmacometrics
We have a current opportunity for a Director Pharmacometrics on a permanent basis. The position will be a hybrid based role in Pennsylvania. For further information about this position please apply. Job Title: Director of Pharmacometrics Location: Pennsylvania, USA Company: Mid Sized Pharma Job Type: Full-Time Job Summary: We are seeking a highly skilled and experienced Director of Pharmacometrics to lead our pharmacometrics team. The successful candidate will be responsible for developing and implementing pharmacometric strategies to support drug development programs, from early discovery through late-stage clinical development and regulatory submissions. Key Responsibilities: Lead and manage the pharmacometrics team, providing strategic direction and mentorship. Develop and implement pharmacometric modeling and simulation strategies to support drug development programs. Collaborate with cross-functional teams, including clinical pharmacology, biostatistics, regulatory affairs, and clinical development, to ensure alignment of pharmacometric activities with overall project goals. Conduct population pharmacokinetic (PK) and pharmacodynamic (PD) analyses, exposure-response modeling, and clinical trial simulations. Provide and implement constructive collaboration within development teams and other internal partners (ex: , Regulatory Affairs, DMPK, Clinical Development, and Biostatistics). Prepare and review pharmacometric reports and regulatory submission documents. Represent the company in interactions with regulatory agencies and external stakeholders. Stay current with advancements in pharmacometric methodologies and software tools. Contribute to the development of best practices and standard operating procedures for pharmacometric analyses. Qualifications: Ph.D. in Pharmacometrics, Pharmacokinetics, Clinical Pharmacology, or a related field. Minimum of 10 years of experience in pharmacometrics within the pharmaceutical or biotechnology industry. Proven track record of leading pharmacometric teams and successfully supporting drug development programs. Expertise in population PK/PD modeling, exposure-response analyses, and clinical trial simulations. Proficiency in pharmacometric software tools such as NONMEM, Monolix, R, and MATLAB. Strong understanding of regulatory requirements and guidelines related to pharmacometrics. Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. Strong problem-solving skills and the ability to think critically and strategically. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Generous paid time off and holidays. Professional development opportunities. Relocation assistance, if applicable.
US$210000 - US$250000 per year
Pennsylvania
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Director, Drug Discovery (Novel Biologics)
Director, Drug Discovery - Biologics Location: Boston, MA Compensation: $220,000-$255,000 + Significant Bonus and Equity + Industry-Leading Benefits Package A global biopharma leader is seeking an experienced Director, Drug Discovery to take on a high-impact role in advancing biologics programs across multiple modalities, including cell therapies, bispecifics, immune cell engagers, and novel antibody-based therapeutics. This individual will play a critical role in shaping drug discovery strategy, leading functional screening and characterization efforts, and driving data-informed candidate selection for preclinical development. As a key scientific and strategic leader, this director will oversee a team of 7-10 scientists while also working cross-functionally as a program lead. They will be responsible for integrating discovery insights into broader pipeline decision-making, ensuring seamless progression from target identification through candidate nomination and IND-enabling studies. This is an opportunity for an established drug discovery leader to drive enterprise-level impact, working across multiple therapeutic areas including immuno-oncology, autoimmune, GI, inflammation, and neuroscience. The role offers broad exposure to cutting-edge biologics and the ability to influence discovery efforts across a rapidly expanding organization. Key Responsibilities: Lead discovery strategy for biologics programs, ensuring functional screening and characterization insights drive candidate selection and advancement. Serve as a program lead, spending approximately 30-40% of time working cross-functionally with research, development, and translational teams to align early discovery efforts with broader pipeline goals. Manage and develop a high-performing team of 7-10 scientists, fostering technical excellence, innovation, and career growth. Oversee the implementation of advanced discovery workflows, including high-throughput screening and emerging AI/ML-driven approaches. Partner with internal and external stakeholders to evaluate new technologies, therapeutic opportunities, and strategic collaborations that enhance biologics discovery efforts. Contribute to long-term organizational growth, playing a key role in the company's ongoing expansion and commitment to delivering multiple IND filings in the coming years. Requirements & Qualifications: Ph.D. in biology, immunology, pharmacology, cell therapy, or a related field with 12+ years of research experience. Industry experience in biologics drug discovery, with a track record of successfully advancing therapeutic candidates from early-stage discovery through IND. Strong expertise in biologics screening, functional characterization, and mechanistic assessment of novel drug candidates. Leadership experience managing scientific teams, with a demonstrated ability to mentor and develop both Ph.D. and non-Ph.D. researchers. Cross-functional collaboration skills, with experience working alongside research, preclinical, and translational teams to drive data-driven decision-making. Experience in biologics modalities such as cell therapies, bispecifics, immune cell engagers, or novel antibody-based platforms.
Negotiable
Boston
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Associate Director Clinical Pharmacology
About Our Client: Our client is a pioneering biopharmaceutical company dedicated to discovering and developing groundbreaking therapies that leverage the body's natural regulation of protein levels to treat a wide array of diseases. Their mission is to revolutionize patient care through the power of targeted protein modulation. Why Join Our Client: Our client offers a collaborative and dynamic work environment where innovation thrives. Their team is composed of passionate and talented individuals committed to making a difference in the lives of patients. They provide competitive compensation, comprehensive benefits, and opportunities for professional growth and development. Current Opportunities: Our client is currently seeking talented professionals to join their team in various roles, including: Research and Development: Scientists and researchers with expertise in drug discovery, medicinal chemistry, and biology. Clinical Development: Clinical pharmacologists, clinical trial managers, and regulatory affairs specialists. Data Science and Bioinformatics: Experts in data analysis, bioinformatics, and computational biology. Manufacturing and Quality: Specialists in process development, quality assurance, and regulatory compliance. Business and Operations: Professionals in project management, business development, and corporate operations. Featured Position: Associate Director of Clinical Pharmacology Position Overview: Our client is looking for a highly skilled and motivated Associate Director to join their Clinical Pharmacology group. As an early member of this team, you will have the unique opportunity to shape the direction of their clinical pharmacology efforts across both early and late-stage programs. The ideal candidate will be proficient in developing and executing clinical pharmacology strategies, including PK/PD modeling and simulation activities such as population PK/PD modeling, physiologically-based PK (PBPK) modeling, and quantitative systems pharmacology (QSP) modeling. Your expertise will be crucial in optimizing doses, dosage regimens, and study designs through data analysis, interpretation, and presentation of findings. You will also play a key role in authoring and reviewing clinical pharmacology documents for regulatory submissions and responses. Key Responsibilities: Develop clinical pharmacology development plans, timelines, and study prioritization. Oversee and contribute to clinical pharmacology sections of clinical study protocols, SAPs, CSRs, stand-alone PK/PD reports, and clinical development plans. Collaborate with multidisciplinary teams to ensure modeling and simulation methods (e.g., QSP, MBDD, PBPK) inform internal decision-making and regulatory relations. Foster cross-functional collaborations with Clinical Operations, Research, Bioanalysis, Biometrics, CMC, and Clinical Sciences to ensure seamless implementation of Phase I-III studies. Integrate PK, PD, and safety data from multiple sources to optimize dosing for patient populations across the development continuum. Provide input on preclinical-stage programs to enhance preclinical effectiveness and biomarker data, supporting the progression of programs into clinical development. Advocate for MIDD across drug discovery and development. Identify and apply state-of-the-art quantitative approaches to projects. Qualifications: PharmD, PhD, or MS in a field related to Pharmacometrics with 5-8 years of industry or similar experience in Pharmacometrics, Clinical Pharmacology, or Quantitative Systems Pharmacology. Demonstrated experience in managing clinical and nonclinical PK/PD projects. Current knowledge of regulatory guidances, global regulations, and SOPs in clinical pharmacology studies. Experience in authoring and reviewing clinical pharmacology documents for regulatory submissions. Proficiency in modeling and simulation techniques in pharmaceutical development, including population PK/PD modeling, PBPK modeling, or QSP modeling. Exceptional oral and written communication skills and excellent problem-solving abilities. Proven ability to work efficiently in a dynamic, team-oriented environment with strong emotional intelligence (respect and empathy). High proficiency in using common software and data analysis packages (e.g., R, WinNonlin, Simcyp, GastroPlus, Monolix, NONMEM).
US$180000 - US$210000 per year + Medical, Dental, Vision, 401K
San Francisco
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Director, Pharmacometrics
I'm seeking to connect with highly skilled and motivated Director of Pharmacometrics candidates to join a leading pharma company. This hands-on role will involve leading pharmacometric analyses to support multiple in-house 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 7 years of hands-on modeling experience 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. Small Molecule Background
US$220000 - US$230000 per year
New Jersey
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Director of Pharmacometrics
The Director of Pharmacometrics will play a crucial role in optimizing dosing regimens, ensuring regulatory compliance, and contributing to the overall success of therapeutic projects. Key Responsibilities: Lead and oversee the development and application of pharmacometric models to support drug development and regulatory submissions. Collaborate with clinical pharmacology, biostatistics, and other interdisciplinary teams to inform clinical trial designs and data analysis. Develop and implement model-based strategies to optimize dosing regimens and therapeutic outcomes. Ensure the accuracy and quality of pharmacometric analyses and reports. Mentor and provide scientific guidance to a team of pharmacometricians and other scientific staff. Engage with regulatory agencies and prepare regulatory submission documents related to pharmacometric analyses. Stay abreast of the latest developments in pharmacometrics and incorporate new methodologies and technologies as appropriate. Present findings and strategies to senior management and cross-functional teams. Develop and maintain standard operating procedures (SOPs) for pharmacometric activities. Qualifications: PhD in pharmacometrics, pharmaceutical sciences, pharmacokinetics, or a related field. Extensive experience with non-linear mixed effects modeling. Proven track record of successful regulatory submissions involving pharmacometric analyses. Excellent leadership and mentoring skills. Strong publication record in peer-reviewed journals. Experience with software tools like NONMEM, Monolix, or similar platforms. Exceptional communication and collaboration skills. Preferred Skills: Strong analytical and problem-solving abilities. Ability to work effectively in a fast-paced, dynamic environment. Experience in managing multiple projects simultaneously. Familiarity with the latest advancements in pharmacometric methodologies and technologies.
US$210000 - US$230000 per year
Massachusetts
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Associate Director, Clinical Pharmacology
This role will be pivotal in driving the clinical pharmacology strategy for our biologics programs, from pre-IND through to post-approval. The successful candidate will integrate clinical pharmacology knowledge with a broad understanding of related disciplines to support and impact development decisions. Key Responsibilities: Lead the design and implementation of clinical pharmacology studies for biologics, including PK/PD modeling and simulation. Provide scientific oversight for preclinical PK/TK studies and clinical pharmacology studies. Collaborate with cross-functional teams including clinical development, regulatory, bioanalytical, and biostatistics to ensure robust study designs and data analyses. Develop and apply innovative modeling and simulation strategies to optimize dose selection and study design. Analyze and interpret PK/PD data to support dose selection, study design, and proof-of-concept. Prepare and review regulatory documents including INDs, NDAs, and BLAs. Serve as the clinical pharmacology expert on project teams, providing strategic input and guidance. Manage relationships with external vendors and consultants to ensure high-quality deliverables. Qualifications: PhD, PharmD, or equivalent in pharmacokinetics, pharmaceutical sciences, or related discipline. Minimum of 5 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry, with a focus on biologics. Strong expertise in PK/PD modeling and simulation, including population PK and PBPK modeling. Experience with regulatory submissions and interactions. Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. Strong analytical and problem-solving skills, with the ability to interpret complex clinical data. Preferred Qualifications: Experience in autoimmune diseases and/or immunology. Familiarity with anti-FcRn technology and its clinical applications. Proven track record of successful regulatory submissions for biologics.
US$180000 - US$190000 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 Pharmacometrics
We have a current opportunity for a Director Pharmacometrics on a permanent basis. The position will be a hybrid based role in Pennsylvania. For further information about this position please apply. Job Title: Director of Pharmacometrics Location: Pennsylvania, USA Company: Mid Sized Pharma Job Type: Full-Time Job Summary: We are seeking a highly skilled and experienced Director of Pharmacometrics to lead our pharmacometrics team. The successful candidate will be responsible for developing and implementing pharmacometric strategies to support drug development programs, from early discovery through late-stage clinical development and regulatory submissions. Key Responsibilities: Lead and manage the pharmacometrics team, providing strategic direction and mentorship. Develop and implement pharmacometric modeling and simulation strategies to support drug development programs. Collaborate with cross-functional teams, including clinical pharmacology, biostatistics, regulatory affairs, and clinical development, to ensure alignment of pharmacometric activities with overall project goals. Conduct population pharmacokinetic (PK) and pharmacodynamic (PD) analyses, exposure-response modeling, and clinical trial simulations. Provide and implement constructive collaboration within development teams and other internal partners (ex: , Regulatory Affairs, DMPK, Clinical Development, and Biostatistics). Prepare and review pharmacometric reports and regulatory submission documents. Represent the company in interactions with regulatory agencies and external stakeholders. Stay current with advancements in pharmacometric methodologies and software tools. Contribute to the development of best practices and standard operating procedures for pharmacometric analyses. Qualifications: Ph.D. in Pharmacometrics, Pharmacokinetics, Clinical Pharmacology, or a related field. Minimum of 10 years of experience in pharmacometrics within the pharmaceutical or biotechnology industry. Proven track record of leading pharmacometric teams and successfully supporting drug development programs. Expertise in population PK/PD modeling, exposure-response analyses, and clinical trial simulations. Proficiency in pharmacometric software tools such as NONMEM, Monolix, R, and MATLAB. Strong understanding of regulatory requirements and guidelines related to pharmacometrics. Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. Strong problem-solving skills and the ability to think critically and strategically. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Generous paid time off and holidays. Professional development opportunities. Relocation assistance, if applicable.
US$210000 - US$250000 per year
Pennsylvania
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Director Pharmacometrician
Job Title: Director of Clinical Pharmacometrics Job Type: Full-Time Location: New Jersey We're representing a leading biopharmaceutical company dedicated to discovering and developing innovative medicines that improve patient outcomes. We are committed to advancing the science of pharmacometrics to support drug development and regulatory decision-making. Position Summary: We are seeking a highly skilled and experienced Director of Clinical Pharmacometrics to lead our pharmacometrics team. The successful candidate will play a critical role in developing and implementing quantitative modeling strategies to support clinical drug development programs. You will oversee all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. This position requires a deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), and disease progression modeling. Key Responsibilities: Lead and manage the clinical pharmacometrics team, providing strategic direction and mentorship. Develop and implement quantitative modeling strategies to support clinical drug development. Collaborate with cross-functional teams, including clinical development, biostatistics, regulatory affairs, and medical writing. Interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Design and conduct population PK/PD analyses, exposure-response modeling, and disease progression modeling. Interpret and communicate modeling results to internal and external stakeholders Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices. Contribute to the preparation of regulatory submissions and responses to regulatory agencies. Stay current with advancements in pharmacometrics and modeling methodologies. Publish research findings in peer-reviewed journals and present at scientific conferences. Qualifications: Ph.D. in Pharmacometrics, Pharmacokinetics, Pharmacology, or a related field. Minimum of 8 years of experience in clinical pharmacometrics, with a strong emphasis on modeling. Proven track record of leading and managing a team of pharmacometricians. Extensive experience with population PK/PD modeling, exposure-response modeling, and disease progression modeling. Proficiency in modeling software such as NONMEM, Monolix, or similar tools. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work collaboratively in a fast-paced, dynamic environment. Preferred Qualifications: Experience in regulatory interactions and submissions. Strong publication record in peer-reviewed journals. Familiarity with advanced modeling techniques such as machine learning Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Generous paid time off and holiday schedule. Professional development opportunities.
US$230000 - US$260000 per year
New Jersey
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Director of Clinical Pharmacology
We have a current opportunity for a Director of Clinical Pharmacology on a permanent basis. The position is fully remote. Key Responsibilities: Lead the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) studies. Develop clinical pharmacology plans that support regulatory submissions (IND, NDA, BLA) and provide strategic input throughout all stages of drug development. Collaborate with clinical, regulatory, biostatistics, and other R&D teams to interpret data and guide decision-making in clinical development. Serve as the clinical pharmacology expert in interactions with regulatory authorities, presenting clinical pharmacology data and strategies. Support dose selection strategies, contribute to clinical trial design, and ensure optimal use of modeling and simulation approaches. Mentor and manage a growing team of clinical pharmacologists and pharmacometricians. Stay current on new scientific developments, regulatory guidelines, and industry trends in clinical pharmacology and related fields. Qualifications: PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, or a related discipline. 8+ years of experience in clinical pharmacology and drug development within the pharmaceutical or biotech industry. Proven track record of successfully leading clinical pharmacology programs from early to late-stage development. Must have large molcule and strong experience with MAB.
US$235000 - US$245000 per year
United States of America
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Associate Director Clinical Pharmacology
Develops, implements, and manages comprehensive Clinical Pharmacology plans and strategies that align with commercial objectives and regulatory standards across multiple functions. Initiates and leads new PK/PD study proposals. Proactively assesses and addresses advancements, strengths, weaknesses, opportunities, and threats in Clinical Pharmacology, PK/PD, and regulatory landscapes, adapting strategies accordingly. Demonstrates a strong track record of achieving Clinical Pharmacology and business goals. Oversees Clinical Pharmacology/PK/PD aspects of various projects, ensuring thorough evaluation of technical and scientific elements in collaboration with Clinical Pharmacology and Pharmacometrics management. Description: Responsible for designing Phase 1-4 studies and developing clinical pharmacology strategies; serves as the project representative. Executes strategies, leads teams, and interprets data by providing necessary context, including explaining mechanisms of action, disease specifics, relevant data, analysis plans, and model results. Authors regulatory documents such as protocols, study reports, population PK reports, exposure-response analyses, CTDs, label sections, investigator brochures, white papers, and similar documents. Leads clinical pharmacology and biopharmaceutics meetings, represents Clinical Pharmacology at Clinical Strategy Team/Asset Development Team, and presents at various departmental and cross-functional teams. Guides small teams within Clinical Pharmacology to present a unified position to clinical, CMC, and regulatory teams. Authors scientific publications, presents at national and international conferences, and interacts with key opinion leaders and external stakeholders. Conducts due diligence assessments, summarizes findings, and represents Clinical Pharmacology on business development teams. Represents Clinical Pharmacology at regulatory meetings. Qualifications: Required to be on-site 3 days a week. PhD with 4+ years of experience, PharmD with 6+ years of experience, Master's Degree with 12+ years of experience, or Bachelor's Degree with 14+ years of experience in relevant fields (e.g., PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, drug metabolism/transporters). Excellent interpersonal skills. Ability to interact with functional representatives and key opinion leaders, and lead teams. Strategic thinking and broad perspective. Proven scientific track record and technical expertise. Key Leadership Competencies: Delivers business results while positioning the company for long-term success. Persistent and resilient, advancing good ideas. Acts with respect and courage. Connects unrelated concepts and generates unique ideas. Influences colleagues for cross-functional alignment. Delegates and accepts accountability. Additional Information: Compensation range is based on job grade and may vary by geographic location. The range may be adjusted in the future. Comprehensive benefits package includes paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. Eligible for short-term and long-term incentive programs.
US$180000 - US$190000 per year + Medical, Dental, Vision, 401K
San Francisco
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