Senior Director, Global Regulatory Affairs
EMD Serono

Billerica, Massachusetts

This job has expired.


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.

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:

Lead a growing team to deliver on the vision of equipping EMD Serono to be a leader in precision medicine through excellence in scientific discovery, clinical translation and companion diagnostic development driving value by treating the right patient with the right medicine.

Lead the GRA companion diagnostics (CDx) and devices team to support all Project teams across the enterprise, including the growing Oncology TA with the development, and approval of CDx/ Devices and support their commercial utility.

Implement EMD Serono wide CDx and Precision Medicine (PM) regulatory strategy, in conjunction with technical, development, commercial, IP and business development teams by leading PM projects and work streams according to agreed deliverables, timelines and budget. Embed a culture of change that embraces CDx approaches in drug development through building collaboration and breaking down silos between groups that work in the Biomarker continuum within EMD Serono and externally.

This position will report to Head Global Regulatory Affairs, Oncology & Companion Diagnostics.

KEY RESPONSIBILITIES:

  • In collaboration with core teams within R&D and Commercial, establish diagnostic GRA strategies at the pipeline and project level
  • Establish strategic partnerships to deliver diagnostic solutions to support the pipeline
  • Ensure team exhibits timely management and delivery of projects/work streams within agreed budget
  • Must be able to manage multiple projects and workstreams across TAs, GHO and R&D, including assessment of workload and resourcing requirements to deliver the team's objectives
  • Maintain an up-to-date knowledge of all assigned projects, strategy and progress. Clearly and concisely report projects progress and outcomes
  • Ensure learnings and best practices are shared across R&D
  • Liaises with Project teams, TA heads, and other core team leaders.
  • Works with policy, BD, TAs and business unit colleagues and key leadership within project teams
  • Works with project leads to ensure efficient implementation of all key deliverables
  • Provides frequent project status updates related to PMDx/ Device deliverables and finances
OTHER SKILLS NEEDED:
  • Proven ability to strategize, prioritize, and manage multiple projects simultaneously to ensure quality, timely, on-target and within budget accomplishment of tasks.
  • Managerial experience with demonstrated track record of successfully managing high-performance cross-functional matrix teams in a complex organization
  • Ability to lead strategic thinking
  • Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
  • Attention to detail with excellent planning, time management and organizational skills
  • Excellent communication and presentation skills, high- level negotiation skills and the ability to resolve conflict in a constructive manner

ADDITIONAL DETAILS:

A CDx leader is required to understand assay development, medical device regulatory, clinical trial design and execution and worldwide regulations in order to deliver a CDx product that gets commercialized and sold globally. To be successful, you must be able to integrate and synthesize development and commercial CDx strategy for Sr Management communication, managing complex variables with high degrees of uncertainty to align a drug and device GRA program.
  • This role requires interacting in a matrix environment with a number of stakeholders, including functional line leads for clinical, stats, operations, quality and biomarker development
  • This role requires interaction with teams in US, EU, Canada, China, and Japan at minimum.

Who You Are:

Minimum Qualifications:
  • M.D. or Ph.D. in the Biological Sciences and 10 years of pharmaceutical and IVD manufacturer experience or M.S. with 15+ years of Pharma experience.
  • Understanding of drug discovery & development, especially late stage development and approval process and life cycle management
  • Broad knowledge of technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)
  • Proven track record of having supported CDx product development (pre-submission packets, SRD and IDE authoring and PMA documentation) for class II and class III devices
  • Understanding of drug discovery & development, especially late stage development and approval process and life cycle management
  • Understanding of IVD development, including design history file evaluation, risk assessments and all related analytical and clinical validation requirements
  • Experience performing due diligence and auditing vendors for CDx test placement.
  • Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
  • Understanding of CLSI, NYDOH and other industry standards for assay validation
  • Understanding of IVD regulations, including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
  • Able to integrate and synthesize development and commercial CDx strategy for Sr Management communication
  • Must be detail oriented with strong organization skills in order to manage and meet deliverables
  • Deep scientific and regulatory expertise with criteria described above
Preferred Qualifications:
  • Significant experience leading large teams of leaders leading 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!

Curious? Apply and find more information athttps://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.

Job Requisition ID: 220139

Location: Billerica

Career Level: E - Professional (10+ years)

Working time model: full-time


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