Nestlé Skin Health is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives.
Nestle Skin Health aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases.
Nestlé Skin Health is a subsidiary of Nestlé.
For our Global SIG Rx organisation, we are currently looking for 2 :
Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be attached to the Head of Medical Expertise and will be :
Responsible to provide a medical strategy, leadership, and expertise to individual (phase 1, 2, 3, or 4) clinical trials within a development program.
Activities and responsibilities :
Works as part of a diverse team, accountable for design, implementation, execution, and submission / approval of a clinical development plan to support decision milestones, regulatory requirements, and budget targets
Supports the development and execution of the Clinical Development Plan (CDP), adhering to Galderma clinical / data standards of quality for Phase I II III - IV trial
Ensures from a medical perspective that individual protocols are consistent with CDP and are aligned to achieve the Target Product Profile (TPP)
Supports Clinical development team for protocol development and full protocol package processing
Responsible for advising investigators and / or CRO on medically relevant questions during study execution
Supports Clinical development team for scientific aspects of data review / SSRM / coding / edit checks / CRF / DMC / other study documents
Develops presentation materials for trial-related advisory boards, investigator meetings, and protocol training meetings
As required, establish, implement, and support IDMC
Accountable for excellence in clinical trial strategy, design, execution and reporting ensuring high quality data is obtained
Responsible for continuous evaluation of drug benefit risk profile, including the aspects of relevance to patients in clinical studies, as well as external stake holders (e.
g., health authorities) in collaboration with Global Safety group
Supports ongoing review of clinical trial data, final analysis, and interpretation in collaboration with development team members
Provides medical strategy (i.e. medical rationale, objectives and end points) to clinical development protocols, plans, study outlines, investigator brochures, briefing packages, CTDs, draft labels, and other documentation as required
May interact with external and internal stakeholder in support of Research and / or Strategic opportunities including : target identification, review of programs at preclinical stage and due diligence, together with other medical matters as required
May serve as disease area scientific and medical expert with external stakeholders (e.g., regulatory authorities, CRO, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.
g., Research, Global Medical Affairs, Marketing, HEOR), Nestlé Research Units (e.g. NRC, NIHS), and internal decision boards
Delivers all relevant components / documents for maintenance of product licenses (e.g., clinical benefit-risk assessments for license renewals, responses to Health Authority)
Participates in scenario development for clinical development to support decision analysis and optimal resource allocation in program
Supports team to manage, forecast, and allocate resources (FTEs and budget) for the clinical program as needed&
Accountable for timely execution of clinical deliverables within approved budget
Supports clinical communication strategy in coordination with Scientific Communications
Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of Clinical Development members as appropriate
Expected qualifications :
Medical Degree required, dermatologist and experience in conducting clinical trials preferred, experience developing systemic agents (large and / or small molecule)
Prior experience in clinical research or drug development in an academic, CRO, or industry environment (industry experience preferred)
Experience with regulatory submissions and health authorities preferred
Must possess strong interpersonal and problem solving skill
Demonstrated experience in data presentation
Organizational awareness including significant experience working cross-functionally and in global teams
Experience in conducting clinical trials preferred
Experience developing systemic agents (large and / or small molecule)
Capable to work collaboratively and effectively in a matrix environment with multi-disciplinary functions
Must possess excellent interpersonal and communication skills with high learning agility
Must have prior experience in working with highly outsourced model
Exhibits and / or possesses strong learning agility, adaptability, and change management skill
Fluent in English, written and oral
Location : Lausanne Region, Switzerland.
Date : As of Q2 2018