Clinical Development Lead Adult Gut Health

仕事内容

Position Snapshot

Location: Lausanne, Switzerland

Company: Nestlé Health Science

Permanent Contract

Full-time, Act. Rate 100%

Master Degree with minimum of 5-10 years’ experience in Clinical Development with a strong understanding of the gastro-intestinal market (pharma, biotech, diagnostics, medtech, nutrition).

Genuine opportunities for career and personal development

Dynamic international working environment

Position Summary

Founded in 2011, Nestlé Health Science (NHSc) is a globally recognized leader in the field of nutritional

science, committed to redefining the management of health. We offer an extensive portfolio of science-based consumer health, medical nutrition, supplement brands, and pharmaceutical therapies.

NHSc is headquartered in Switzerland and we have more than 7,000 employees around the world, with a presence in 66 countries.

As Global Clinical Development Lead Adult Gut Health, you will lead the development and implementation of clinical development strategies for the Business Area Adult GI Health under your responsibility, in alignment with the NHSc business strategy, to support successful market and patient access for NHSc nutritional products. You will drive and oversee design, execution, analysis and reporting of clinical studies in collaboration with the clinical operations team R&D community within Nestlé Health Science and the broader Nestlé, in alignment with the overall corporate strategy.

A day in the life of a Global Clinical Development Lead Adult GI

• Being part of developing a new global business that incorporates nutritional solutions, diagnostics, and pharmaceuticals within the area of GI Health, assimilate, digest and transform all relevant scientific and clinical information/facts necessary for developing and implementing the medical and clinical aspects of the GI Health strategy in emerging areas including Microbiome, Inflammatory Bowel Disease/Immunology & Liver Disease and Acute Care Health.
• Manage, directly or indirectly, the clinical development of the projects in nutritional GI Health. Lead and coordinate the clinical efforts needed for product expansions in different regions.
• Bring clinical and medical expertise to establish strong connections with internal & external experts, Patient Groups and relevant internal and external stakeholders in the field of GI Health and nutrition, drugs development and diagnostics.
• Actively represent and lead the clinical development matters for NHSc in GI within strategic alliances and ongoing partnerships
• Develop and execute portfolio clinical strategies for both product development and life cycle management, in support of the nutritional GI health strategy.
• Develop clinical development plans driven by intended use (claims) and value propositions. Ensure their integration into Evidence Development Plans (EDPs), consider development path, intellectual property, areas of unmet needs, epidemiology, regulatory and market access.
• Integrate diagnostics and pharmaceutical therapy with nutrition as key part of the therapy, ideally leading to new standard of care of treatment.
• Integrate nutrition and nutritional physiology knowledge in the development programs and strategy.
• Serve as senior NHSc GI clinical expert internally and externally and represent clinical development before regulatory agencies, payers and other medical decision making committees.
• Develop and maintain relationships with KOLs to deliver high value clinical studies and communications for NHSc GI products.
• Make clinical presentations to key stakeholders in academia, regulatory agencies, reimbursement bodies to help establish medical value, clinical utility and credibility of NHSc products.
• Establish strong interaction within R&D, especially those involved in GI research and development across Nestle and actively participate in due diligence efforts, as well as development of the innovation strategy.
  

What Will Make You Successful

• Medical Doctor (MD) with minimum of 5-10 years’ experience in Clinical Development with a strong understanding of the gastro-intestinal market (pharma, biotech, diagnostics, medtech, nutrition).
• Board certification in (adult) gastroenterology or equivalent qualification considered relevant. Background in medical nutrition and/or microbiome would be considered a strong asset.
• In depth experience with design and management of clinical trials.
• Experience in leading clinical development programs successfully with breath of early through late Phase experience, registration and market launch with a compelling value proposition, including successful US and Global registration.
• Experience in regulatory submissions to the FDA, EFSA and other regulatory agencies, including interaction with these agencies on novel trial designs and new indications as well as the ability to effectively address inquiries from investigators, customers, internal teams and external agencies.
• Experience in building and leading an R&D therapeutic area in a high-growth environment
• Understanding of the regulated (medical) food environment (e.g EFSA, FDA) considered a plus.
• Ability to analyze, interpret and make decisions on complex scientific information. Ability to effectively address inquiries from investigators, customers, internal teams and external agencies.
• Fluent in English