Early Clinical Development Lead, Neurology and Immunology Director Clinical Research

Posted 11 Jan 2023

Billerica, Massachusetts - United States

Req Id 259722

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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:

 

  • Early Clinical Development Lead represents the Global Clinical Development function in the Research Units’ relevant teams (e.g. Discovery Project Teams, DPT) and other appropriate committees.
  • Serve as the Early Clinical Development Representative within the DPTs or GPTs to ensure the definition of a clear path to FiH and PoC and related Go / No Go criteria – Early Clinical Development representatives may also serve as clinical leads within the DPTs.
  • Provide input into the clinical development/medical relevance of innovative targets, the design and interpretation of preclinical studies investigating efficacy, safety and biomarker profiling of novel compounds, at all phases of research and preclinical development.
  • Provide input into the design and interpretation of studies based on advanced analytics of real-world data (RWD), pre-clinical and clinical trial results, to support precision medicine strategies.
  • Contribute to the proposal, planning and implementation of investigational studies specifically addressing experimental medicine issues (e.g. patient profile, efficacy and safety biomarkers, identification of combination partners).
  • Contribute to the overall strategy for a biomarker-based patient selection across the related therapeutic areas together with the Biomarker functions and contribute to the generation of the iDP and clinical trial protocol.
  • Collaborate with Subteams to translate the preclinical data set into a meaningful and efficient early clinical development plan and designing associated clinical studies accordingly.
  • Critically review sections of documents including, but not limited to, protocols, the investigator brochure, clinical study reports, patient narratives, and submission related documents
  • Coordinate clinical R&D efforts involving reverse translational research in close collaboration with the Bioinformaticians, Biostatisticians and the group of Quantitative Pharmacology
  • Present the early clinical development strategy at investigator meetings, scientific advisory boards and health authority
  • Establish and maintain strong relationships with key opinion leaders with an emphasis on building active relationships with clinical centers
  • Provide input in the course of Due Diligence processes, to evaluate new assets and/or new technical platforms, to ensure their added value for the TA portfolio and the Organization.
  • Provide input to the evaluation of Investigator sponsored trials, to evaluate new assets and ensure their added value within the N&I portfolio

 

  • Serve as representative in relevant Committees
  • Support / Contribute to annual budget and resource planning.
  • Increase scientific knowledge in the Neurology and Immunology organization by attending international congresses and related workshops. Promote and assist the organization of scientific development activities within the Department, such as internal courses and inviting external speakers and contribute to development advisory board meetings.

 

Who You Are:

Minimum Qualifications:

  • Medical Degree (MD) with Ph.D or substantial post doctoral basic laboratory experience
  • In-depth knowledge of ICH-GCP and other applicable regulatory guidelines / practices
  • Extensive research experience documented by a track record of publication in scientific peer-reviewed journals

 

Preferred Qualifications:

  • Successful track record of clinical trial leadership, with in-depth understanding of the requirements for IND/CTA enabling studies and clinical trial procedures
  • Extensive experience in interactions with Health Authorities in Europe and US
  • Global recognition as expert in clinical drug development with profound knowledge in research, translational and precision medicine, clinical development from early development to proof-of concept
  • Requires substantial professional experience in Immunology, including clinical trials:
    • 8+ years of clinical experience in academia or industry
    • Experience in a pharmaceutical or biotechnology industry, including a deep understanding of all development phases
  • Fluency in English
  • Entrepreneurial spirit and action / results driven
  • Very strong analytical skills and solid strategic orientation
  • Strong team player, able to work in a complex matrix organization with experience in multi-cultural and cross-functional teams
  • Working experience with relevant R&D interface partners, Research including a deep understanding of research methods, Pharmacology, DMPK, Toxicology & Safety Pharmacology, Biomarker development, Clinical Development & Operations and Regulatory Affairs
  • Understanding the needs of R&D as well as non-R&D (e.g. marketing, portfolio management) interface partners, external academic, biotech and pharmaceutical collaborators as well as regulatory agencies
  • Excellent initiative and driven by a strong sense of the urgency.
  • Ability to work in a constantly changing and challenging environment


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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