Associate Director, Head of Clinical Assay Development (CAD)

Posted 15 Sep 2020

Billerica, Massachusetts - United States

Req Id 208535

Details

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:

 

As Head of Clinical Assay Development (CAD) for New Biological Entities within the Drug Disposition & Design department, you will be responsible for managing a team of scientists to develop clinical bioanalytical PK and immunogenicity (ADA/Nab) assays.

 

You will provide scientific oversight of assay transfer and validation at CROs and be accountable that outsourced clinical assays are performed in compliance with current guidelines and internal standards.

 

You will participate in the development and implementation of a consistent and aligned assay strategy to support preclinical and clinical studies and IND/BLA/NDA submission. Through internal collaboration and external interactions, you will help drive innovation in the area of NBE DMPK. Your work will support biotherapeutics projects from early discovery through Life Cycle Management (LCM), primarily for clinical phases.

 

Who you are:

 

Minimum qualifications:

  • Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years of experience, or PhD in life science or related discipline required

 

Preferred qualifications:

  • MS degree with 8+ years of experience, or PhD degree in pharmacokinetics, immunology, biochemistry, or related field with 5+ years of industrial experience
  • Experienced in clinical PK and immunogenicity assay development and validation, on LBA platforms, such as ELISA, MSD, Gyros and Quanterix
  • Experienced working in GLP/GCP regulated environment, in-depth knowledge of FDA/EMA regulations on bioanalytical assays
  • Excellent knowledge of CRO operations and experience managing CROs (including issue resolution) on clinical bioanalytical assays. 
  • General knowledge of drug development & discovery processes, disease biology & pharmacology
  • Fluent spoken and written English
  • Cooperative mindset, ability to work in matrixed teams, and able to contribute to budget projections
  • Excellent managerial, organizational and communication skills
  • German, Chinese or additional languages a plus

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

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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