Galderma is a global leader focused on changing the way the world thinks about skin health. Galderma was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. As part of Nestlé Skin Health, Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin.
For our Global SIG Rx organization, we are currently looking for:
Senior Medical Expert (M/F)
Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will report to the Head of Medical Expertise and will be responsible for providing medical input, leadership, and expertise to clinical programs, including overall medical leadership and strategy to the development plan and execution of a clinical protocol(s).
Activities and responsibilities:
•May fill the role of clinical development team lead within the SIG and/or an external Clinical Research Organization which is responsible for a clinical program with a compound being developed in one or more indications
•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
•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 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, HE&OR), Nestlé Research Units (e.g. NRC, NIHS), and internal decision boards
•Develops presentation materials for trial-related advisory boards, investigator meetings, and protocol training meetings
•As required, establish, implement, and support IDMC
Supports ongoing review of clinical trial data, final analysis, and interpretation in collaboration with development team members
•Accountable for design, implementation, execution, and submission/approval of a clinical development plan to support decision milestones, regulatory requirements, and budget targets
•Accountable for the development and execution relating to the medical input to the Clinical Development Plan (CDP), adhering to Galderma clinical/data standards of quality for Phase I – II – III - IV trials
•As member of a clinical development team, ensures 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
•Advises investigators and/or CROs on medically relevant questions emerging during study execution
•Supports Clinical development team for medical/scientific aspects of data review/SSRM/coding/edit checks/CRF/DMC/other study documents
•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
•Accountable for creation of and for giving critical input to clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access, and commercialization of the compound(s)
•May fill the role of leader of clinical interactions with external and internal stakeholder and supports Research and Strategic Opportunities Departments including target identification, review of programs at preclinical stage and due diligences together with other medical matters as needed
•May act as medical expert and leader in interactions 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, HE&OR), Nestlé Research Units (e.g. NRC, NIHS), and internal top management decision boards
•Delivers all relevant components/documents for maintenance of product licenses (e.g., clinical benefit-risk assessments for license renewals, responses to Health Authorities)
•Drives 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
•In conjunction with clinical and medical affairs team, plans and executes publication and clinical communication strategy
•Supports career development of other clinical colleagues
Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of Clinical Development Team members as appropriate.
Expected qualifications:
•Medical Degree required, Dermatologist preferred with advanced knowledge in clinical development and experience in all development phases preferred
•Minimum of 10 years of involvement in clinical research or drug development including Biologics in an academic or industry environment spanning clinical activities in Phases I through III including at least 5 years relevant industry experience
•Minimum of 10 years of demonstrated leadership, management, and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing), or sections of clinical programs in a global/matrix environment (including remote) in pharmaceutical or biotech industry
•Experience with regulatory submissions and health authority interactions required
•Minimum of 5 years people management experience required, this may include management in a matrix environment
•Proven ability to interpret, discuss, and represent efficacy and safety data derived from clinical trials
•Considerable organizational awareness including significant experience working cross-functionally and in global teams
•Medical and operational expertise in relevant therapeutic area required. Demonstrated technical knowledge and innovation in clinical development study designs that provide relevant evidence to decision-makers
•Experience developing systemic agents (large and/or small molecule)
•Prior experience in working with highly outsourced model. Includes managing and familiarity in working with CROs
•Excellent interpersonal and communication skills with high learning agility
•Exhibits and/or possesses strong learning agility, adaptability, and change management skills
•Fluent oral and written English