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Senior Scientific Director, Clinical Pharmacology
A career with EMD Serono is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
You will be serving a dual-role of the Senior Clinical Pharmacology Expert Team Lead (CPET-L) and the Clinical Pharmacology (CP) expert. Senior CPET-L is a strategic, scientific and cross-functional role, leading an expert team with a high level of technical and strategic independence and accountability for model-informed drug development for high-complexity projects. This team comprises subject matter-experts from CP, Pharmacometrics, Translational Modeling & Simulation, Clinical Biomarker, Drug Metabolism and Pharmacokinetics, and, on an ad-hoc basis, other global functions. This role represents the CP Expert Team to the global project team.
As a highly independent scientific and strategic leader by virtue of his/her deep scientific expertise and experience in driving model-informed drug development across drug development phases, modalities, mechanisms and/or therapeutic areas, the senior CPET-L provides strong leadership for integrating individual functional contributions, driving the model-informed drug discovery and development (MID3), developing CP translational strategy in alignment with the overall clinical development plan, aligning with the stakeholders, and executing the program strategy/plan according to appropriate timeline.
• The approach includes, but is not limited to, quantitative translation from bench to bedside and reverse translation back to the bench, knowledge integration from literature or external data to internal programs, with regarding to pharmacokinetics, pharmacodynamics, disease progression,
relevant covariates (such as baseline disease, target, and pathway) and posology/dosage aiming to move the program to the next stage leading to regulatory submissions and life cycle management or an early termination with speed, efficiency and innovation based on data and MID3 approach in close collaboration with the experts on the team.
• The scope includes the internal programs from exploratory development through life cycle
management, and relevant external collaboration programs of all stages related to quantitative
pharmacology discipline, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas with emphasis on oncology, immuno-oncology, neurology and immunology.
As a cross-functional team leader, this role leads relevant workstreams at the CP Expert Team, is accountable for providing integrated team input to the GPT and leading/participating in highly interactive discussions at both levels. This role requires a sense of urgency with a strong can-do attitude in identifying and driving the debate around key issues while keeping the big picture and long-term targets in mind. Therefore, it is vital for this individual to have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities. As a key component of this role is independent formulation of the regulatory clinical pharmacology strategy and defense of all components of the clinical pharmacology and pharmacometrics dossier at global Health Authority meetings, robust experience in regulatory science aspects of clinical pharmacology (e.g., pediatric dose selection/ extrapolation strategy, ethnic sensitivity assessment and Asian bridging strategies, bioequivalence and biowaiver strategies, PBPK and exposure-response-informed dosage and administration guidelines, product labeling) is expected.
Senior CPET-L is responsible for establishing the processes for team collaboration and providing feedback on performance of individual team members with a goal of creating a winning team culture.
Senior CP Expert Team Lead may also act as a function group lead and SME within function group depending on his/her experience. Senior CPET-L will also act as the CP expert on the team. As a CP expert, you will support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the targeted population, applying principles of MID3.
Who you are:
• Bachelor’s degree with 20 plus years of experience, master’s degree with 15 plus years of
experience, or PhD with 7 plus years of experience is required.
• PhD or MD in related sciences or equivalent training in clinical pharmacology, PK/PD sciences,
pharmacometrics or allied disciplines preferred.
• Direct industrial experience of 10 plus years of experience is strongly preferred.
• Strong understanding of clinical drug development strategies, and quality related requirements in
drug development in GXP-related areas.
• Ability to independently deploy model-informed drug development strategies (e.g., translational PK/PD model-informed dose selection, PBPK model-informed DDI risk assessment, population PK and exposure-response guided pediatric extrapolation, population pharmacology-based Asian bridging strategy, and model-informed clinical pharmacology characterization for product labeling)
• Significant professional experience in at least one of the translational sciences areas
• Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc.
• Track record in delivering in discovery and development settings.
• General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth
understanding of biology and pharmacology is a plus.
• Excellent knowledge of regulatory requirements and submission across the main regions.
• Strong understanding about translational sciences such as quantitative pharmacology, safety and biomarkers
• Robust knowledge of and experience in regulatory science aspects of clinical pharmacology as applied in global drug and biologic development, associated Health Authority interactions and product labeling
• Externally recognized for scientific leadership in the field of clinical pharmacology/ pharmacometrics as evidenced by publications, Board certification, and/ or leadership roles in scientific organizations, consortia or Editorial Boards of scientific journals.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
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