Position Title: Senior Scientist Clinical Innovation, Advanced Research
The Clinical Innovation team within Advanced Research is responsible for driving upstream clinical validation of efficacy of bioactives, formulations, diagnostics and wearables that will be transformed into consumer products. This requires knowledge and continuous improvements of existing methodologies and development of novel evaluation protocols for both skin and hair. This role requires collaboration globally with other teams involved in the innovation process including clinical research, formulation, biology/chemistry/biophysics, statistics, safety, regulatory, claims and external CROs.
- Be a driving force for efficacy evaluation using clinical and instrumental methodologies in skin care including but not limited to skin aging, hydration, pigmentation.
- Provide guidance to strategic partners in formulations/biology/chemistry/biophysics teams on appropriate clinical tests, evaluations, timing, CRO selection and cost.
- Develop clinical studies protocols, synopses or amendments; manage the delivery of clinical study protocols to CROs and IRBs, contractual study agreements; Oversight TMF files and archiving.
- Monitor study progress such as recruitment and protocol compliance using Electronic Data Capture (EDC) or electronic case report files (eCRF) systems
- Drive resolution of data issues and queries from the clinical studies through follow up between data management, CRO and statistics teams
- Track, review, report and manage study progress and budget
- Communicate and present clinical study results
- Cultivate and maintaining strong collaborative relationships with internal and external partners
- Comply with FDA regulations, Good Clinical Practice (GCP) guidelines and SOP’s for clinical studies.
- Represent clinical operations at the team level for individual studies and point of contact for all project activities with vendor(s)
- Master’s Degree or higher in the Biomedical Sciences, Biochemistry, Pharmaceutical or Cosmetic Sciences.
- 3 to 7 years of experience managing clinical trials in cosmetic, personal care, pharmaceutical or OTC industries and working with CROs
- Knowledge of skin biology, structure and function with hands on experience in skin bio-instrumentation and clinical efficacy assessments, analysis and interpretation.
- Knowledge of scientific methods, research design, medical practices and procedures that would be acquired through experience with human medical/cosmetic research studies
- Comprehensive understanding of the cosmetics development process, contributing to the clinical strategy and creation of the clinical development plans while working as part of an integrated team
- High level of organizational, prioritization, project management skills, problem solving and desire to innovate in a fast paced environment with sufficient sense of urgency to meet imposed timelines
- Understanding and adherence to ethical practices in human research studies, Good Clinical Practices and FDA regulations.
- Excellent oral and written communication skills.
- Ability to identify and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.
- Collaborate with the clinical support teams on the review, analysis, and interpretation of study results.
- Team oriented, collaborative and capable of working in a global company with diverse culture.
- Available for domestic and international travel (~10%).
- Legally eligible to work in the USA in a continuous basis.
We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
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