Salesforce Developer

Chemistry, Leadership Automation Governance Innovation Biomarkers Statistics Compassion Mathematics Forecasting Simulations Data Science Digital Data Cell Therapy Pharmacology Communication Presentations Team Building Biostatistics Data Modeling Accountability Program Design Decision Making Real World Data Database Design Small Molecules Drug Development Pharmacodynamics Pharmacokinetics Machine Learning Telephone Skills Data Engineering Biopharmaceutics Clinical Research Matrix Management Biopharmaceuticals Influencing Skills Advanced Analytics Regulatory Filings Data Visualization Portfolio Analysis Business Development Contingent Workforce Strategic Leadership Clinical Pharmacology Business Intelligence Computational Biology Biomedical Engineering Artificial Intelligence Pharmaceutical Sciences Pre-Clinical Development Early Clinical Development Clinical Trial Development Verbal Communication Skills Interdisciplinary Collaboration Multicast Address Allocation Server Non-Disclosure Agreement (Intellectual Property Law), The Head of QP2 Oncology will serve as the enterprise point of accountability for QP2 strategy, ensuring quantitative science is used to shape program design, dose and regimen strategy, regulatory interactions, governance recommendations, and portfolio decisions. The leader will provide strategic leadership and scientific oversight, supervise and mentor other scientists, directly shape strategy for priority programs and business-development opportunities, and build a modern quantitative operating model for oncology development., Marketing Chemistry Leadership Automation Governance Innovation Biomarkers Statistics Compassion Mathematics Forecasting Simulations Data Science Digital Data Cell Therapy Pharmacology Communication Presentations Team Building Biostatistics Data Modeling Accountability Program Design Decision Making Real World Data Database Design Small Molecules Drug Development Pharmacodynamics Pharmacokinetics Machine Learning Telephone Skills Data Engineering Biopharmaceutics Clinical Research Matrix Management Biopharmaceuticals Influencing Skills Advanced Analytics Regulatory Filings Data Visualization Portfolio Analysis Business Development Contingent Workforce Strategic Leadership Clinical Pharmacology Business Intelligence Computational Biology Biomedical Engineering Artificial Intelligence Pharmaceutical Sciences Pre-Clinical Development Early Clinical Development Clinical Trial Development Verbal Communication Skills Interdisciplinary Collaboration Multicast Address Allocation Server Non-Disclosure Agreement (Intellectual Property Law) +0

Salesforce Developer AVP/ Head, Quantitative Pharmacology & Pharmacometrics - Oncology Merck & Co., Inc

Rahway, NJ*On-Site

Oncology Marketing Chemistry Leadership Automation Governance Innovation Biomarkers Statistics Compassion Mathematics Forecasting Simulations Data Science Digital Data Cell Therapy Pharmacology Communication Presentations Team Building Biostatistics Data Modeling Accountability Program Design Decision Making Real World Data Database Design Small Molecules Drug Development Pharmacodynamics Pharmacokinetics Machine Learning Telephone Skills Data Engineering Biopharmaceutics Clinical Research Matrix Management Biopharmaceuticals Influencing Skills Advanced Analytics Regulatory Filings Data Visualization Portfolio Analysis Business Development Contingent Workforce Strategic Leadership Clinical Pharmacology Business Intelligence Computational Biology Biomedical Engineering Artificial Intelligence Pharmaceutical Sciences Pre-Clinical Development Early Clinical Development Clinical Trial Development Verbal Communication Skills Interdisciplinary Collaboration Multicast Address Allocation Server Non-Disclosure Agreement (Intellectual Property Law) +0

• Ph.D. or equivalent degree
• At least 15 years of experience in drug development, including at least 5 years in oncology in industry
• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

Required Experience and Skills:

• Drug development expertise within the oncology therapeutic area, including a record of both internal and external impact in driving model-informed drug development strategies
• Experience with multiple modalities such as ADCs, small molecules, TCEs and/or biologics
• Track record of publications or presentations in quantitative pharmacology for oncology
• Ability to influence regulatory strategies including experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA) for more than one modality (biologics, ADCs, small molecules, cell therapy)
• Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists
• Experience in performing population PK/PKPD analyses using standard pharmacometric software
• Up to date on emerging trends/works in field (peer intelligence, methodology emerging analyses
• Scientific understanding of biopharmaceutical and ADME properties of both small molecules and biologics
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
• Ability to formulate and articulate scientific strategy to support for portfolio decisions
• Ability to embed MIDD early in asset strategy, including population PK, PK/PD, exposure-response, dose optimization, simulation-based trial design, model-based meta-analysis, quantitative systems pharmacology, disease-progression modeling, and translational modeling
• Ability to recommend and defend dose and regimen decisions supported by integrated evidence packages that address efficacy, safety, tolerability, exposure, biomarkers, patient selection, and regulatory expectations
• Has a comprehensive understanding of global regulatory expectations for oncology development for dose and pharmacology; contributing to cross-functional regulatory strategy; reviewing INDs, CSRs, CTDs, NDAs/BLAs/MAAs; and representing QP2 leadership at regulatory interactions
• Willingness and experience to apply AI/ML, automation, real-world data, biomarker, translational, and digital data-stream approaches where they improve prediction, accelerate learning, or strengthen development decisions
• Ability to serve as a senior representative for QP2 in cross-functional teams, governance discussions, portfolio reviews, and business-development or licensing evaluations
• Experienced in team building and maintaining a high-performing, modality-agile organization in close collaboration with discovery oncology and with strong oncology expertise, technical excellence, regulatory credibility, consistent modeling standards, and the ability to influence across functions
• Must be able to lead with influence to partner with others to build effect models and datasets,
• Must have excellent communication and collaboration skills.

Required Skills: Business Intelligence (BI), Business Intelligence (BI), Cellular Therapies, Clinical Development, Clinical Pharmacology, Clinical Reporting, Clinical Research, Clinical Trial Development, Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Drug Development, Drug Research, Machine Learning (ML), Matrix Management, Mechanism of Action, Model Development, Model Driven Design, Oncology, Pharmaceutical Sciences, Pharmacodynamics, Pharmacokinetics, Pharmacology {+ 5 more}, Valid Driving License

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The salary range for this role is $282,200.00 - $444,200.00

Our company is seeking a head of Quantitative Pharmacology & Pharmacometrics (QP2) to lead pharmacology strategy for our oncology pipeline. Our QP2 organization uses trial and external data, advanced analytics, model-informed drug development, and deep therapeutic-area expertise to inform the safety, efficacy, dose, schedule, patient-selection, and benefit-risk strategies for the pipeline. The QP2 team integrates clinical pharmacology, pharmacometrics, quantitative systems pharmacology, exposure-response analysis, translational modeling, biomarkers, real-world data, and emerging AI/ML-enabled approaches to support decision-making across discovery, early clinical development, registration, and life-cycle management., Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.