Scientific Director, Quantitative Pharmacology

Posted 08 Nov 2021

Billerica, Massachusetts - United States

Req Id 233020

Details

 

A career with EMD Serono 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. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

 

 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

 

 

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 Quantitative Pharmacology (QP) within the broader Translational Medicine organization is a strategic, scientific and cross-functional role of deploying strategic MID3 & pharmacometrics (PMx) plans as well as leading programs as Clinical Pharmacology Expert Team Lead from the early translational to the late-stage clinical development in cross functional drug discovery and development project teams. The individual will work in close collaboration with colleagues in Clinical Biomarkers and Diagnostics, Bioinformatics, Biostatistics, Research, Clinical Development and other colleagues within the R&D organization and represent QP in global project teams (GPT).

The individual is expected to know the Clinical pharmacology (CP) strategy and the ways to integrate MID3 plans to develop novel medicines with the right dose (level, regimen and adjustments with different conditions and specific populations) and right drug combination for the right patient population and to provide health authorities and prescribers with appropriate information.  

The Scientific Director provides strong leadership for integrating individual functional contributions from QP, developing MID3 strategy in alignment with the overall clinical development plan, seeking the endorsement from management, and executing the program strategy/plan according to appropriate timeline.

 

  • This scientific leader will enable strategic integration of advanced modeling & simulation (M&S) methodologies (e.g., disease models, model-based meta-analysis, Bayesian decision analytics, clinical trial simulations, RWD pharmacometrics, AI/ML)  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 MID3 strategy, and execution of the agreed upon strategy/plan according to appropriate timelines to influence internal decision-making and contribute to regulatory filings.
  • 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.

 

Your Responsibilities

  • Ensures that CP & MID3 strategy is developed, aligned (with cross-functional development plans), endorsed and executed with studies scheduled in a cost-effective manner to support the indication, patient population, and phase of development while taking into account the competitive landscape
  • Chair regular CP Expert Team meetings, record minutes, and provide decisions / recommendations to line management and the Program Lead or Manager (PgL/PgM) or Global project team (GPT)
  • Be accountable, conduct  and/or oversee Pharmacometrics (PMx) deliverables (e.g., population PK, PK/PD, exposure-response, PBPK) and corresponding regulatory submission documents for assigned programs across the drug development lifecycle
  • The preparation of CP related section of major clinical and regulatory documents (clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books, etc.)  and cross-functional responses to health authority ‘requests for information’ concerning the CP scientific areas
  • 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.
  • Keep up-to-date with scientific development in MID3 space and share expertise with colleagues
  • Interacts with the leader from TxM biomarker expert team to represent a unified view from TxM aiming at selecting right dose, right combination and right population
  • May need to contribute as a member of in-licensing due diligence teams if needed
  • Participate into MID3 research by mentoring summer interns or managing academic externalized works as needed

 

Who you are:

Minimum 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 or engineering;

 

Preferred Qualifications:

  • Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas.
  • Excellent knowledge of drug discovery & development
  • Track record in delivering in discovery and development settings
  • 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,
  • 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.
  • 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.
  • 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!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

Curious? Apply and find more information at https://jobs.vibrantm.com

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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.

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