Clinical Trial Management - Head of Clinical Bioanalytical Operations

Posted 17 Dec 2019

Billerica, Massachusetts - United States

Req Id 201451

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:

The Head of Clinical Bioanalytical Operations is responsible for developing and implementing bioanalytical outsourcing strategies, efficiently managing CROs for given projects, and delivering validated clinical bioanalytical and immunogenicity assays & data.

 

This role is accountable for ensuring outsourced clinical bioanalytical and immunogenicity activities are performed according to the agreed timelines and quality and in compliance with current guidelines and internal standards.

 

  • Assure all aspects necessary for contracting studies are in place. This includes developing and maintaining a strong working relationship with support functions (Procurement, Legal, Quality Management)
  • In addition, leadership of the team that is responsible to outsource and monitor the clinical pharmacokinetic and immunogenicity sample analysis at the bioanalytical vendors and ensure timely delivery of results.  
  • Line management responsibilities include management of resource allocation, work prioritization, performance management and active development of people.
  • Oversee the budget for outsourced studies.
  • The person in this role will be responsible for implementing appropriate project management tools in order to manage timelines and deliverables for multiple studies and resources employed at CRO labs.
  • Accountable for an inspection-ready bioanalytical outsourcing process which meets GCP compliance and quality requirements
  • Maintain a robust and effective relationship with preferred partner CROs in given projects and manages any issues to an effective resolution.

 

Who you are:

A strong and accomplished leader who is able to drive, develop and lead teams. An individual who can guide, energize, influence and motivate people. Someone who can understand and provide input into operational strategy for bioanalytical outsourcing management. Someone who has excellent written and verbal communication skills; able to swiftly build trust-based relationships with internal and external contact persons.

 

A person with excellent budget and situational negotiation and conflict management skills. Strategic thinking and analytical skills, quick assessment and excellent judgment; able to identify risks and problems, to develop innovative problem-solving strategies even in complex situations, and to take appropriate measures when required. Novel thinking beyond own function; is familiar with and considers overall business objectives and company corporate strategy.

 

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:

 

  • An advance degree in a life science or related discipline preferable
  • 8 plus years’ experience, in clinical and drug development in the pharmaceutical/biotech/CRO industry preferred
  • 5 years of experience in the development, transfer to CRO and validation of bioanalytical assays, monitoring of PK/ADA or Biomarker analysis to support preclinical and clinical studies in drug development preferred
  • Knowledge of GLP, GCLP guidelines, ICH-GCP, clinical trial process, other relevant Guidance documents (from ICH, FDA, EMEA etc.), and of regulations and requirements for analysis of clinical samples
  • Keeping abreast with modern and novel technologies in the bioanalytical space, regulatory guidance, industry best practices, White Papers relevant to clinical bioanalysis to ensure practices are consistent with regulatory expectations and high scientific standards
  • Prior experience in leading a team, resource management, talent acquisition, and developing employees
  • Demonstrated experience in collaborating with other functions in a complex matrixed organization
  • Strong project management skills, willing to take on and build efficient business processes, able to identify risks and implement mitigation strategies
  • Strong communication skills, both written and verbal

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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