Global Head of Translational Quantitative Pharmacology (all genders)

Your Role:
The Global Head of Translational Quantitative Pharmacology is a senior scientific leadership and global management role responsible for the overall Translational Quantitative Pharmacology activities across the R&D value chain for all therapeutic areas (e.g., Oncology, Immuno-oncology, Immunology, Neurology, Global Health) and all therapeutic modalities (e.g., small molecules, biologics including monoclonal antibodies, bi-/ multi-specific constructs, and antibody-drug conjugates) in the company\’s portfolio to fulfill internal and global regulatory requirements. In this role, the incumbent will show leadership and provide guidance to the global team of direct reports across sites towards best performance and scientific excellence in the application of state-of-the-art translational modeling and simulation approaches in their role on Project Teams and Clinical Pharmacology Expert Teams. A key mandate of the role is to drive strategic integration of Quantitative Systems Pharmacology (QSP) modeling and simulation in translational and early development to optimize decision-making and increase confidence across the pillars of Target, Patient and Dose, and to be accountable for the scientific integrity and quality of resulting work products including reports and summary documents included in regulatory filings (e.g., IND). S/he may delegate for the Global Head of QP in governance and advisory settings requiring translational M&S expertise (e.g., RULT, Human Exposure Group).
Key Accountabilities:

• Accountable for line management, mentorship and development of a cross-site global team of translational M&S scientists with a vision for Quantitative Systems Pharmacology-enabled translational research and clinical development
• As a member of Quantitative Pharmacology leadership, contributes to the building, function and harmonization of the global QP organization, and its smooth integration within Clinical Measurement Sciences
• Ensures robust collaboration of TQP scientists across sites with CPET Leads and scientists in Clinical Pharmacology and Pharmacometrics within the QP organization, thereby contributing to optimal model-informed drug development strategies throughout the lifecycle from translational through clinical development.
• Ensures optimal representation of the TQP discipline on cross-functional teams (e.g., project teams, CPET) across the R&D continuum and fosters a culture of QSP-enabled research and early development
• Ensures adequate support for translational M&S topics in internal and external meetings, HA consultations etc.
• Collaborates with Research Units to influence design of the right pre-clinical program and analyses (dose, schedule, and sequencing) to optimize the translational strategy using a mechanism-based model-informed approach.
• Drives a culture of model-informed assessment and enhancement of confidence in Target (e.g., confidence in therapeutic hypothesis), Patient (e.g., assessment of potential impact of target expression and other features on efficacy) and Dose (e.g., projection of therapeutic exposure window and human efficacious dose and regimen for single agent and combination settings).
• Ensures integration of knowledge about human ADME/PK/interaction properties and PD to contribute to multi-dimensional optimization of lead candidates and candidate selection for clinical development.

• Ensures state-of-the-art quantitative PBPK predictions (for both small molecules and biologics) to support development candidate selection, IND/IMPD, and clinical development
• Evaluates and implements new approaches and techniques for translational M&S, importantly QSP, embracing advances in computational and data sciences, and its integration in the context of Model-informed Drug Development and Model-Informed Precision Medicine strategies
• Elevates the practice of QSP M&S at the portfolio level, including enablement of clinical stage QSP by integrating multimodal predictive and pharmacodynamic biomarker data in multi-scale models, leveraging virtual populations and digital twins, thereby enabling patient stratification/ selection decisions and dosage optimization in clinical development
• Serves as the ambassador of the organization in key external consortia and research partnerships aimed at advancing the science of Quantitative Systems Pharmacology for R&D applications
• Accountable for the integrity and quality of translational M&S input to regulatory documents (e.g. Human dose projection reports, Investigator Brochure, IMPD, IND, NDA/BLA) and documents used for internal management reviews and decision making (e.g., presentations to RULT, Human Exposure Group, DULT)
• Is accountable for the quality of the global team deliverables, both scientifically and in alignment with internal and regulatory guidelines and best practices

• Ensures the quality of outsourced M&S analyses and that the generated results and reports meet applicable international regulatory requirements.
• Represents QP in due diligence teams for external opportunity evaluations with a high level of technical and strategic independence, for projects in the pre-IND or early clinical stages where TQP expertise is identified as a crucial component of due diligence. May delegate for the Global Head of QP in governance and advisory settings requiring translational M&S expertise (e.g., RULT, Human Exposure Group).

Financial Dimension:

• Accountable for overall budget discipline in the global TQP organization for all outsourced project and platform research initiatives.
• Ensures a culture of active budget management through proactive forecasting and monitoring of progress against goals within assigned budget in all outsourced activities managed by the global TQP organization including external research partnerships led by TQP scientists across sites and membership in academic and industry consortia.

Strategic Impact:

• Guarantees the scientific quality of Translational QP deliverables, meeting internal and external expectations, thereby ensuring better informed decisions on development candidate selection, confidence in target/ therapeutic hypothesis, optimized dose and dosing schedule/ regimen selection, and increased probability of success of development programs
• Represents the company/organization at internal & external committees/bodies to build the reputation of EMD Serono with respect to scientific excellence in translational quantitative pharmacology
• Is internally and externally recognized as a thought leader in Quantitative Systems Pharmacology with outstanding competence in formulating strategies for QSP-enabled research and early clinical development of complex therapeutic modalities (e.g., bispecific constructs, antibody-drug conjugates, etc.) and across therapeutic areas (e.g., immuno-oncology, oncology, immunology)

Scope of Responsibility:

• Global manager of the Translational QP function within the QP organization comprised of PhD-level direct and indirect reports across sites (Billerica, Darmstadt)
• Drives commitment to a culture of Quantitative Systems Pharmacology-enabled research and early development
• Recruits, retains and develops people to build a world class team with state-of-the-art expertise in translational modeling and QSP (staff in Germany, US)
• Provides high quality feedback and coaching to direct reports and mentor key talents in the organization.
• Creates individual career development plans
• Fosters productive reviews

Location: Can be based in Billerica, MA or Darmstadt, Germany.
Who You Are:
Minimum Qualifications:

• PhD; 8+ years of experience in the application of Quantitative Pharmacology in a pharmaceutical R&D setting including experience in developing PhD modelers
• Experience and hands-on competence in applying Quantitative Systems Pharmacology (QSP) in mathematical modeling of pharmacologic effects using relevant software or programming languages (e.g., MATLAB/Simbiology, NONMEM, R)
• Experience in applying translational M&S to the research and clinical development of both small molecules and biologics, including emerging complex modalities and combinations.

Preferred Qualifications:

• Experience in applying translational PK/PD M&S including QSP approaches in research and early clinical development to inform confidence in target/ mechanism, dose/ regimen, and combinations.
• Sound knowledge of basic principles of biology and pharmacology at the organismal, cellular and molecular level, preferably in one or more of the following areas: oncology, immuno-oncology, immunology
• Ability to rapidly assimilate knowledge of complex biology of drug action for novel mechanisms and transform such understanding into multi-scale mathematical models, with requisite mathematical and computational proficiency
• Experience in applying PBPK modeling and simulation using relevant software (e.g., MATLAB, Simcyp, GastroPlus)
• Strong knowledge of principles of ADME/ pharmacokinetics, PK/PD sciences, and regulatory guidelines applicable to translational development including selection of First-In-Human starting doses and IND development.
• Experience with clinical stage QSP integrating multimodal predictive and pharmacodynamic biomarker data in multi-scale models, leveraging virtual populations, advances in data sciences/ AI and digital twins.
• Documented history of scientific output in the form of peer-reviewed publications and regulatory documents
• Strong track record of leadership and influence skills enabling successful application of model-informed drug discovery and development strategies to inform decision-making, and external scientific presentation and publications.
• Demonstrated ability to coach, mentor and manage talent
• Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment across the enterprise and externally; ability to work effectively with other company leaders
• Strong leadership and influencing skills
• Outstanding presentation, communication and organization skills; ability to lead, influence, and motivate others.
• Ability to distill complex issues and clearly articulate / present solutions
• Good intercultural understanding
• Strong analytical skills and result-orientation
• Passion for talent development
• Strong integrity and a commitment to improving patient outcomes

Department: HC-RD-BQG Global Teanl. QP Platform Excel.
Job evaluation: AT-level 4 (Manager) #J-18808-Ljbffr