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Clinical Development Lead - Innovative drugs for Inborn Errors of Metabolism - IEM

Clinical Development Lead - Innovative drugs for Inborn Errors of Metabolism - IEM

Epalinges, CH

Epalinges, CH

Position Snapshot

 

Location: Epalinges, Switzerland
Company: Nestlé Health Science
Undefined period of time contract
Full-time, Act. Rate 100 %
Medical doctor (MD) with drug development expertise, ideally in the field of Inborn-Errors-of-Metabolism (IEM)
 

Position Summary

 

NHSc is headquartered in Switzerland and employs over 5,000 people around the world. We currently produce over a billion nutritional health solutions for consumers, patients and their healthcare providers. We also distribute industry-leading Vitamins, Minerals and Supplements brands (VMS) in both the healthcare practitioner and consumer channels, making NHSc uniquely positioned to cater to the most pressing health concerns of today.

 

As Clinical Development Lead you will drive the clinical drug development strategy and respective implementation of the clinical development programs in alignment with the NHSc business strategy. You will lead and oversee design, execution, analysis, interpretation and reporting of clinical studies along all phases of drug development in collaboration with the clinical operations team, the overall R&D community within Nestlé Health Science and the broader Nestlé. The successful candidate will act as a senior scientific leader in the Nestle Health Science global drug product development organization.

A day in the life of a Clinical Development Lead

 

  • Provide strong clinical and scientific leadership for developing innovative drugs (such as oral enzyme therapies) for Nestle Heath Science (NHSc) with a focus on “Inborn errors of Metabolism”
  • Develop thorough and risk-adjusted regulatory and clinical development strategies and execute respective clinical trial programs. A track record of drug development in the “orphan disease” space, especially in the field of inborn-errors-of-metabolism will be considered an important expertise
  • Develop and lead clinical development plans driven by unmet medical need and value propositions and ensure their integration into “Evidence Development Plans”. Consider drug development guidance, intellectual property, scientific basis and pathophysiology, epidemiology, as well as regulatory (emphasis on IND/NDA/BLA) and market access environments.
  • Embrace pharmaceutical therapy alongside diagnostics and nutrition/supplementation as key part of the therapy, in order to aim for holistic standards of care for patients with inborn-errors of metabolism.
  • Serve as senior NHSc “Inborn-errors-of-Metabolism” Clinical Expert and represent NHSc at major health regulatory agencies, scientific community, payers and other medical decision-making committees.
  • Develop and maintain relationships with top external experts to ensure opportunity maximization of clinical development programs and communications for NHSc
  • Deliver excellence in clinical presentations to key stakeholders in academia, regulatory agencies and reimbursement bodies to support establishment of medical value, clinical utility and credibility of NHSc products
  • Establish strong interaction within NHSc R&D teams, especially those in enzyme/protein research as well as our business focus on “inborn errors of metabolism”
  • Actively participate in business development initiatives, such as due diligence efforts and continuous evolution of the innovation strategy
What will make you successful

 

  • Ideally Medical doctor (MD) with board-certification indicative for profound clinical experience in patients with inborn errors of metabolism
  • Experience in Clinical Drug Development in either early and/or late-stage (incl. regulatory approval & launch) is clearly desired
  • In depth experience with design, conduct, analysis, interpretation and reporting of randomized clinical trials (RCTs), ideally in the regulated environment of “orphan disease” and related networks
  • Track record of relationship building with external partners (incl. scientific community network) and cross-functional internal teams to execute clinical development programs
  • Experience in regulatory interactions with health authorities (e.g. FDA, EMEA, PMDA) is desirable.
  • Expertise in medical writing (incl. scientific publication track record) and excellent verbal communication and presentation skills

 

The Nestlé Group is the world’s largest food and beverage company with 92.6 billion Swiss Francs in sales in 2019. It is present in 190 countries around the world, has 413 factories and its 308,000 employees are committed to Nestlé’s purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and services for people and their pets throughout their lives. Its more than 2000 brands range from global icons like Nescafé or Nespresso to local favourites. Company performance is driven by its Nutrition, Health and Wellness strategy. Nestlé is based in the Swiss town of Vevey where it was founded more than 150 years ago. Learn more about our Group and reasons to join us on www.nestle.com.

Position Snapshot

 

Location: Epalinges, Switzerland
Company: Nestlé Health Science
Undefined period of time contract
Full-time, Act. Rate 100 %
Medical doctor (MD) with drug development expertise, ideally in the field of Inborn-Errors-of-Metabolism (IEM)
 

Position Summary

 

NHSc is headquartered in Switzerland and employs over 5,000 people around the world. We currently produce over a billion nutritional health solutions for consumers, patients and their healthcare providers. We also distribute industry-leading Vitamins, Minerals and Supplements brands (VMS) in both the healthcare practitioner and consumer channels, making NHSc uniquely positioned to cater to the most pressing health concerns of today.

 

As Clinical Development Lead you will drive the clinical drug development strategy and respective implementation of the clinical development programs in alignment with the NHSc business strategy. You will lead and oversee design, execution, analysis, interpretation and reporting of clinical studies along all phases of drug development in collaboration with the clinical operations team, the overall R&D community within Nestlé Health Science and the broader Nestlé. The successful candidate will act as a senior scientific leader in the Nestle Health Science global drug product development organization.

A day in the life of a Clinical Development Lead

 

  • Provide strong clinical and scientific leadership for developing innovative drugs (such as oral enzyme therapies) for Nestle Heath Science (NHSc) with a focus on “Inborn errors of Metabolism”
  • Develop thorough and risk-adjusted regulatory and clinical development strategies and execute respective clinical trial programs. A track record of drug development in the “orphan disease” space, especially in the field of inborn-errors-of-metabolism will be considered an important expertise
  • Develop and lead clinical development plans driven by unmet medical need and value propositions and ensure their integration into “Evidence Development Plans”. Consider drug development guidance, intellectual property, scientific basis and pathophysiology, epidemiology, as well as regulatory (emphasis on IND/NDA/BLA) and market access environments.
  • Embrace pharmaceutical therapy alongside diagnostics and nutrition/supplementation as key part of the therapy, in order to aim for holistic standards of care for patients with inborn-errors of metabolism.
  • Serve as senior NHSc “Inborn-errors-of-Metabolism” Clinical Expert and represent NHSc at major health regulatory agencies, scientific community, payers and other medical decision-making committees.
  • Develop and maintain relationships with top external experts to ensure opportunity maximization of clinical development programs and communications for NHSc
  • Deliver excellence in clinical presentations to key stakeholders in academia, regulatory agencies and reimbursement bodies to support establishment of medical value, clinical utility and credibility of NHSc products
  • Establish strong interaction within NHSc R&D teams, especially those in enzyme/protein research as well as our business focus on “inborn errors of metabolism”
  • Actively participate in business development initiatives, such as due diligence efforts and continuous evolution of the innovation strategy
What will make you successful

 

  • Ideally Medical doctor (MD) with board-certification indicative for profound clinical experience in patients with inborn errors of metabolism
  • Experience in Clinical Drug Development in either early and/or late-stage (incl. regulatory approval & launch) is clearly desired
  • In depth experience with design, conduct, analysis, interpretation and reporting of randomized clinical trials (RCTs), ideally in the regulated environment of “orphan disease” and related networks
  • Track record of relationship building with external partners (incl. scientific community network) and cross-functional internal teams to execute clinical development programs
  • Experience in regulatory interactions with health authorities (e.g. FDA, EMEA, PMDA) is desirable.
  • Expertise in medical writing (incl. scientific publication track record) and excellent verbal communication and presentation skills

 

The Nestlé Group is the world’s largest food and beverage company with 92.6 billion Swiss Francs in sales in 2019. It is present in 190 countries around the world, has 413 factories and its 308,000 employees are committed to Nestlé’s purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and services for people and their pets throughout their lives. Its more than 2000 brands range from global icons like Nescafé or Nespresso to local favourites. Company performance is driven by its Nutrition, Health and Wellness strategy. Nestlé is based in the Swiss town of Vevey where it was founded more than 150 years ago. Learn more about our Group and reasons to join us on www.nestle.com.

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