Work Your Magic with us! Start your next chapter and join EMD Serono.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

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.

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role

Scientific Director,The Clinical Pharmacology (CP) Expert Team Lead (CPET-Lead) position in Quantitative Pharmacology (QP) within broader Clinical Measurement Sciences (CMS) organization will be scientific and strategic cross-functional lead role, responsible for developing and executing the QP strategies including model-informed drug development (MDD) independently, 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 Development, Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, and other colleagues within the R&D organization. The ultimate aim is to develop the right medicine with the right dosage (level, regimen and adjustments with different conditions and specific populations) and right drug combinations for ALL patients and to provide health authorities and prescribers with appropriate information.   

 

The CP Expert Team Lead provides strong leadership independently for integrating individual functional contributions, developing CP translational strategy in alignment with the overall clinical development plan, seeking the endorsement from management, and executing the program strategy/plan according to appropriate timeline.

The approach includes, but is not limited to, translation from bench to bedside and reverse translation back to the bench, knowledge transferring from literature or external collaboration 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 LCM or an early termination with speed, efficiency and innovation based on data and model informed drug development (MIDD) approach in close collaboration with the experts on the team.The scope includes the internal programs from exploratory development (ED) through life cycle management, and relevant external collaboration programs of all stages related to CP discipline, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas.

As a cross-functional team leader, this role leads relevant workstreams at the CP Expert Team, as well as providing integrated team input to the GPT and leading/participating in highly interactive discussions at both levels Independently.  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.

CP Expert Team Lead 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

 

Who You Are

Minimum Qualifications:

PhD or MD in related sciences or equivalent training, and 5+ years of experience as clinical pharmacology lead and application of MIDD principles in a drug-development setting Fluency in English

Preferred Qualifications:

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 Demonstrated ability for productive collaboration in a multi-disciplinary team, using effective communication and taking personal accountability for timely delivery of results.Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc.Excellent knowledge of drug discovery & development and MIDD principlesTrack record in delivering in discovery and development settingsExcellent knowledge of work packages (non-clinical and clinical) related to PK/PDGeneral knowledge of disease area, more in depth understanding of biology, pharmacologyExcellent knowledge of regulatory requirements and submission across the main regionsGood understanding about quantitative sciences such as quantitative pharmacology, safety and biomarkersGeneral knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html