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Rakuten Medical · 3 days ago

Clinical Scientist

San Diego, CA

Full-time

Hybrid

Mid, Senior Level

$120K/yr - $160K/yr

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies. The Clinical Scientist will provide scientific support for clinical development activities, collaborate with various teams, and execute medical affairs activities to ensure successful clinical studies and maintain regulatory compliance.

BiotechnologyHealth CareMedicalService IndustryTherapeutics

Responsibilities

Contribute to the clinical strategy and creation of the clinical development plans for various oncology indications, working as part of an integrated drug development team

Provide scientific input to protocol development and definition of efficacy and safety endpoints for proof of concept, Phase I, Phase II, and III clinical trials

Collaborate with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assure appropriate data review and accurate data reporting

Prepare data and contribute to scientific publications including posters, abstracts and manuscripts

Support the clinical team with the development of program documents, including the clinical sections of various regulatory documents and submissions to support product approvals

Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations

Present and provide program updates at internal Leadership meetings and external stakeholders event

Proactively seek out and recommend process improvements

Build and manage the IIR/collaboration research and expanded access/compassionate use program(s)

Plan, organize and manage medical-scientific events, symposia, advisory boards (eg. KOL selection, meeting materials, and logistics)

Represent Rakuten Medical at major scientific meetings and conferences. Staff conference booths and develop meeting reviews/reports as assigned

Perform subject-specific literature reviews to assist the organization in staying abreast of the scientific landscape and developments

Create and implement policies, SOPs and work instructions governing the operations of medical affairs to meet all compliance standards and regulations

Establish strong collaborative relationships with key internal and external stakeholders

Serve as medical affairs reviewer for promotional and non-promotional scientific materials

Build and manage the medical information capabilities for Rakuten Medical. Develop and communicate appropriate, quality, compliant, and timely responses for Medical Information requests

Create and maintain a product knowledge database including, but not limited to, written standard response letters and FAQ documents that are scientifically accurate and fair-balanced

Other duties as assigned

May be required to travel up to 30% of the time regionally or international based on project needs

Qualification

Advanced degree in life sciencesOncology expertiseClinical study designDrug development processICHGCP knowledgeAnalytical skillsCommunication skillsInterpersonal skillsCritical thinking

Required

Advanced degree in life sciences (MD, Pharm D, PhD, MS, or equivalent)

Strong scientific background, preferably with clinical and/or research experience in medical, surgical, or radiation oncology

Strong experience of clinical study design, including scientifically, medically and statistically appropriate endpoints

Understanding and ability to apply principles of PK, correlative studies and other studies integrate into clinical research protocols

Comprehensive understanding of the drug development process in all phases of testing with emphasis on Phase 2 and 3 clinical studies

Experience with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements

Strong analytical and strategic thinking skills; detailed oriented, an independent and critical thinker. Proven ability to review, interpret, and present complex scientific data. Ability to multi-task and shift priorities quickly while working under tight deadlines

Excellent verbal, written, and interpersonal communication skills

Preferred

Experience in design, planning, executing, reporting and publishing clinical studies preferred

Disciplinary expertise in oncology is strongly preferred

Prior experience leading or managing medical information functions, reviewing medical and promotional materials with expert knowledge of pharmaceutical regulations and standards, managing investigator-initiated research or collaborative research initiatives, and working with expanded access programs is preferred

Experience with interacting with clinical investigators and medical experts