[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.ResponsibilitiesProvides scientific and/or medical expertise for clinical research aspects of the projectParticipates in strategic meetings/advisory boards as key clinical research representativeProvides 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 leadersProvides support to other functional members of the project teamInteracts with investigators and CROs as the medical or scientific representativeProvides medical and scientific interpretation of efficacy and safety dataParticipates 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 authoritiesProvides input for a project publication plan, liaises with commercial and works on launch activities when requiredCreates and reviews abstracts, and manuscripts created by internal or external sourcesSkillsMedical Degree, PhD, or PharmDAt least 2-4 years in clinical development experiences at a pharmaceutical, biotechnology, CRO company, clinical training/practice, and/or academiaDemonstrated ability to manage multiple and diverse projects concurrentlyDemonstrated ability to develop positive relationships and collaborationsStrong analytical skills; a strategic thinker, planner, and implementerSolid scientific skills and attentive to detailsAbility to operate independently with minimal supervisionDeep experience with literature analysis, proven technical English writing skillsExcellent written and oral communicator in EnglishStrong 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 goalsExperiences in metabolic diseases (Diabetes, Obesity, NASH, NAFLD, etc.), Endocrinology (CKD, CRF, etc.), and Nutrition and Weight Management related drug development are a plusBoard eligibility or certification preferredWorking knowledge of biostatistics is a plusCompany OverviewFounded in 1998, Gan & Lee Pharmaceuticals has successfully developed the first Chinese domestic insulin analog. It was founded in 1998, and is headquartered in Beijing, Beijing, CHN, with a workforce of 1001-5000 employees. Its website is http://www.ganlee.com.