[Remote] Senior Manager, Clinical Scientist
Note: The job is a remote job and is open to candidates in USA. Gan & Lee Pharmaceuticals is seeking a Senior Manager, Clinical Scientist to provide scientific and clinical leadership for clinical development programs. This role involves collaborating with clinical program leads, offering medical expertise, and participating in strategic meetings with stakeholders and regulatory authorities.
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
- Provides support to 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). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities
- Provides input for a project publication plan, liaises with commercial and works on launch activities when required
- Creates and reviews abstracts, and manuscripts created by internal or external sources
Skills
- 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
- Demonstrated ability to manage multiple and diverse projects concurrently
- Demonstrated ability to develop positive relationships and collaborations
- Strong analytical skills; a strategic thinker, planner, and implementer
- Solid scientific skills and attentive to details
- Ability to operate independently with minimal supervision
- Deep experience with literature analysis, proven technical English writing skills
- Excellent written and oral communicator in English
- Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project)
- Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals
- 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
- Working knowledge of biostatistics is a plus
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