Scientific Director, Pharmacometrics Lead Position at EMD Serono

EMD Serono is seeking Scientific Director to join its Pharmacometrics team based in Billerica, Massachusetts USA. To apply click on the link below: https://jobs.vibrantm.com/job/Billerica-Scientific-Director%2C-Pharmacometrics-MA-01821/780541701/ Scientific Director, Pharmacometrics Lead A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role: The Scientific Director in Pharmacometrics (PMx) within our Quantitative Pharmacology organization is a strategic, scientific and cross-functional role of deploying strategic MID3 & pharmacometrics (PMx) plans. You will work in close collaboration with colleagues within the R&D organization. This position will participate in the Quantitative Pharmacology activities to strengthen the PMx platform capabilities by contributing to the strategic use of modeling & simulation (M&S) methodologies across our projects and disease areas, in alignment with the overall clinical development plan and executing the program strategy/plan according to appropriate timelines and involving relevant stakeholders. This position will be responsible for Program/project related PMx assignments either executed independently or in collaboration with external PMx CROs. You develop and execute MID3 strategies/plans fully integrated into the overall preclinical and clinical plans. In using MID3 methodologies you strongly contribute to decision making at critical milestones based on quantitative principles and in close collaboration with global biostatistics, clinical pharmacology expert leads, Medical Sciences, Research, and other quantitative disciplines. You perform hands-on population PK/PD modeling and simulation using state of the art approaches to support project deliverables. Whilst initiating, coordinating and overseeing outsourced PMx activities as needed, you strengthen and build internal PMx platform capabilities on disease progression models. Up to date scientific development in PMx and sharing expertise with colleagues is key as is participating in Pharmacometrics research by developing your own innovative approach or mentoring fellows or overseeing academic externalized works. You contribute to external presentations and publications in the broader scientific/ professional community of clinical pharmacology and pharmacometrics and represent the Quantitative Pharmacology entity in transactions with internal and external stakeholders. In addition to primary accountability for Advanced Pharmacometrics leadership on drug development projects and enabling platforms, may additionally serve as a clinical pharmacology expert team leader on global project teams and/ or due diligence (business development) project teams as the primary representative of the Quantitative pharmacology organization. Who you are: Required Qualificaitons: * 7+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with a doctorate (PhD, PharmD or MD) relevant in the related disciplines of Pharmaceutical Sciences, Statistics or Engineering * Hands-on experience in Pharmacometrics approaches and strategies to be deployed in drug development programs, including but not limited to population PK/PD, disease progression modeling, and clinical trial simulations * Strong understanding and knowledge of statistics, including Bayesian methodologies, as relevant to population modeling, trial simulations, model-based meta-analyses, and other advanced pharmaco-statistical techniques in pharmacometrics * Excellent knowledge in R and/or SAS, NONMEM or related pharmacometrics software Preferred Qualifications: * Experience with Bayesian decision analytic frameworks for pharmacometric M&S-based estimation of probability of success is highly desired * Experience with PBPK modeling and simulation is a plus. * Knowledge of application of AI/ML in quantitative pharmacology is a plus * Experience with translating/ transitioning QSP models to population PK/PD frameworks with multi-dimensional (e.g., -omics) covariates for deployment in clinical development for proof-of-mechanism and reverse translation is a plus * Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases * General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus. * Present strategy and discuss outcome of model-based approaches via interactions with governance boards and regulatory agencies * Promote MID3 internally and externally * Demonstrated ability of productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results * Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks * Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment * Outstanding presentation, communication and organization skills; ability to lead, influence and motivate others. 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/ Regards, Akash Khandelwal PhD Global Head of Pharmacometrics This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. 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