Senior Manager, Clinical Scientist
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AI Summary
Provides scientific and medical leadership for clinical research projects, including the development of core documents like protocols and target product profiles. Manages interactions with regulatory authorities, CROs, and key opinion leaders to ensure program objectives are met.
Summary
This position reports to the Head of Clinical Development at Gan & Lee Pharmaceuticals USA Corporation or designee. The position will work with Gan & Lee clinical program lead(s) to provide the scientific and clinical leadership and inputs in meeting the development objectives for the program.Education and Credentials
- Medical Degree, PhD, or PharmD.
Experience
- 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
Skills
- 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.
- Working knowledge of biostatistics is a plus.
- 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.
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.
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