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.

Requirements

Advanced degree in life sciences (MD, Pharm D, PhD, MS, or equivalent)
Experience in design, planning, executing, reporting and publishing clinical studies preferred.
Disciplinary expertise in oncology is strongly preferred.
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.
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.
Excellent verbal, written, and interpersonal communication skills.

Benefits

Competitive compensation plan
Flexible time off
Stock options
401k
Medical, dental, vision plans and more.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical study designprotocol developmentefficacy endpointssafety endpointsdata analysisscientific publicationsregulatory submissionsmedical information managementPK principlesclinical research protocols

Soft skills

analytical thinkingstrategic thinkingattention to detailindependent thinkingcritical thinkingmulti-taskingcommunication skillscollaborative relationshipspresentation skillsprocess improvement

Certifications

MDPharm DPhDMS