Senior Manager, Clinical Scientist

Responsibilities

• Provides scientific and/or medical expertise for clinical research aspects of the project
• Participates in strategic meetings/advisory boards as key clinical research representative
• Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc.)
• Consults with internal/external stakeholders and internal/external key opinion leaders
• Supports other functional members of the project team
• Interacts with investigators and CROs as the medical or scientific representative
• Provides medical and scientific interpretation of efficacy and safety data
• Participates in the interactions with regulatory authorities (e.g., FDA, EMEA meetings)
• Develops and reviews project publication plans, liaises with commercial teams, and participates in launch activities when required
• Creates and reviews abstracts and manuscripts created by internal or external sources

Qualifications

• Medical Degree, PhD, or PharmD
• At least 2-4 years in clinical development experiences at a pharmaceutical, biotechnology, CRO company, clinical training/practice, and/or academia
• Experiences in metabolic diseases (Diabetes, Obesity, NASH, NAFLD, etc.), Endocrinology (CKD, CRF, etc.), and Nutrition and Weight Management related drug development are a plus
• Board eligibility or certification preferred