Clinical Biomarker Operations Manager

Posted 01 Jul 2019

Billerica, Massachusetts - United States

Req Id 192369



A career with EMD Serono is an ongoing journey of discovery: our 52,000 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:

At EMD Serono the Clinical Biomarker Operations Manager is responsible for being an effective contributor who can provide delivery of Biomarker activity at the asset and clinical trial level, while ensuring rational alignment of asset strategy and protocol execution.  This is including, but not limited to: the set-up and maintenance of biomarker/companion diagnostic (CDx) and related operational frameworks, a key point of contact for cross-functional clinical trial teams and translational medicine leaders, engagement with external vendors, and partnerships and collaboration with cross functional study team members.

This includes:

  • Interface management, through coordinating internal and external activities to provide adequate quality and the timely delivery of biomarker/CDx according to the project needs.
  • Securing an adequate review process for all biomarker & CDx relevant documents by involving the relevant sub-functions.
  • Responsibility for fostering current quality standards and regulation in the clinical environment.  
  • Will be a member of clinical operation and biomarker subteams
  • Organizing regular and ad hoc meetings to ensure adequate functional planning & tracking when required.
  • Documenting associated issues and risks; involved in operational program reviews and with team members, document outcomes, decisions and key learnings
  • Contribute to operational effectiveness in the initiation and oversight for request management of Biomarker assay development or sample analysis; ensures all work is documented in alignment with the protocol and the program strategy
  • Partners with Biomarker leadership to coordinate and execute against the leveraging of internal and third-party relationships to drive sample execution
  • As part of Global Clinical Operations organization, contributes to and supports the need to streamline the processing for cleaning sample metadata as needed to ensure integrity of specimens and downstream analysis


Who you are:

Minimum Qualifications:

  • Bachelor’s degree in Biology, Pharmaceuticals or other Science discipline with 3+ years of experience in clinical operations, or Master’s degree in Biology, Pharmaceuticals or other Science


Preferred Qualifications:

  • PhD or Master’s degree in Biology, Pharmaceuticals or other Science discipline strongly preferred
  • 4+ years clinical operations experiences and a minimum of 2 plus years experiences with clinical biomarker processes.
  • Knowledge in immunology or oncology fields is an asset.
  • Proven regular trainings in GCP.
  • Knowledge of regulations and guidance about companion diagnostic development is an advantage. 
  • Experience working within a matrixed organization  
  • Proven organizational and project management skills
  • Demonstrated experience establishing effective priorities for self, while working with a sense of urgency, delivering on multiple projects and often dynamic deadlines
  • Skilled listener with ability to be involved in complex internal and external relationships; experience with third party governance oversight desirable
  • Acute attention to detail and ability to work with high volumes of data independently with some guidance and support and in collaboration with a multi-disciplinary scientific team
  • Experience in developing and implementing agile, creative solutions, helping to solve business challenges within the line organization, across the company, and in partnership with external collaborators
  • Highly collaborative team player who regularly seeks perspectives both within and outside of his/her direct accountability to develop and implement high value solutions
  • Advanced technical capabilities in Microsoft suite of applications 



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

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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