Scientific Director, Pharmacometrics

Company: Merck Gruppe
Location: Billerica
Posted on: February 22, 2021

Job Description:

Experience the joy of curiosity, search for a job Click here for additional search options 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. Your role: Scientific Director, Pharmacometrics (PMX) position in Quantitative Pharmacology within the broader Translational Medicine organization will be strategic, scientific and cross-functional role, responsible, for developing and executing Model Informed Drug Development (MIDD) plans and strategies from the early translational to the late-stage clinical development in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Clinical Biomarkers and Diagnostics, Bioinformatics, Biostatistics, Research, Clinical Development and other colleagues within the R&D organization. This position will provide important leadership to the overall Quantitative Pharmacology strategy and tactical plan, and will strengthen the PMX platform capabilities. This scientific leader will enable strategic integration of advanced modeling & simulation (M&S) methodologies for assigned small molecule and biologics projects across disease areas, in alignment with the overall clinical development plan. A key expectation of this role is proactive alignment with key stakeholders on the pharmacometric strategy, and execution of the agreed upon strategy/plan according to appropriate timelines to influence internal decision-making and contribute to regulatory filings. This position will be responsible for his/her project related PMX assignments either executed independently, or in collaboration with external PMX CROs, with accountability for high-quality submission-enabling M&S reports. The incumbent will be expected to manage multiple development projects simultaneously and contribute actively in discussions and presentations to senior management. Responsibilities in this role will additionally include scientific leadership of platform research efforts applying advanced pharmacometric methods (e.g., disease models, model-based meta-analysis, Bayesian decision analytics, clinical trial simulations, RWD pharmacometrics, AI/ML) to advance MIDD.

• Develop and execute MIDD strategies/plans fully integrated with the overall preclinical and clinical plans;
• Using MIDD methodologies to strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with global biostatistics, clinical pharmacology expert leads, Medical Sciences, Research, and other quantitative disciplines;
• Initiate, coordinate and oversee outsourced PMX activities as needed;
• Be accountable for population pharmacology deliverables (e.g., population PK, PK/PD, exposure-response, PBPK) and corresponding regulatory submission documents for assigned programs across the drug development lifecycle
• Strengthen and build internal PMX platform capability on disease progression models and clinical trial simulations;
• Keep up-to-date with scientific development in PMX and share expertise with--colleagues
• Contribute to external presentations and publications and be an actively engaged ambassador of EMD Serono in the broader scientific/ professional community of clinical pharmacology and pharmacometrics.
• Participate into Pharmacometrics research by mentoring summer interns or managing academic externalized works Who you are: Required qualifications:
  • 7+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with a doctorate (PhD, PharmD or MD) relevant in the related disciplines of pharmaceutics, clinical pharmacology, Statistics or engineering;
  • Excellent knowledge and hands-on expertise in R and/or SAS, NONMEM and/ or MONOLIX, and related pharmacometrics software
  • Hands-on experience in PMX approaches and strategies to be deployed in drug development programs, including but not limited to population PK/PD, disease progression modeling, clinical trial simulations
  • Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases
  • Strong understanding and working 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
  • Demonstrated ability to present strategy and discuss outcome of model-based approaches via interactions with governance boards and regulatory agencies and promote MIDD internally and externally
  • Demonstrated ability for productive collaboration in a multi-disciplinary 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 Preferred:
    • General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus
    • Experience working with both small molecules and biologics is highly desirable 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! The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Job Requisition ID: 215733 Career Level: E - Professional (10+ years) Working time model: full-time Careers during Covid-19
      Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone's health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. US Disclosure
      The Company is an Equal Employment Opportunity--employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. North America Disclosure
      The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from--8:00am--to--5:30pm--ET Monday through Friday.

Keywords: Merck Gruppe, Billerica , Scientific Director, Pharmacometrics, Executive , Billerica, Massachusetts