Clinical Scientist *PC 1539

Your Role:

This position will lead and/or participate in meetings, reviews, discussions and other interactions regarding early development of Phase I and Phase II pivotal studies to provide clinical science input and guidance to the Biomedicine, Inc. team.

Essential Duties and Responsibilities: 

• Develop the Biomedicine Global Clinical Development plan in collaboration with the Clinical Development Physician for assigned indication(s).
• In collaboration with Clinical Development Physicians/Medical Director, develop innovative clinical study designs.
• Review protocols and provide Clinical Development input into the early development of Phase I and Phase II pivotal studies.
• Review and/or write additional clinical science documentation and/or clinical science input into other documentation managed by Biomedicine (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.).
• Gather, analyze and summarize data and information necessary to create the Clinical Development plan.
• Lead the response generation or assists Clinical Development team in responding to clinical/clinical site inquiries.
• Stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment and participate in competitive intelligence assessments.
• Represent Clinical Development in sub-teams relevant to assigned therapies/indication(s). As needed and appropriate, address Clinical Development study or other program-specific questions; provide updates; deliver presentations; etc. May act as the lead Clinical Development representative on sub-teams.
• Support the completion and submission of regulatory filings and other regulatory documentation.
• Deliver key presentations, both internally and externally, to convey the Clinical Development perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing the company.
• Collaborate with clinical operations, other groups and Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.
• As needed/appropriate, collaborate with others in the review of safety narratives and other safety-related guidelines and participate in safety meetings and track, analyze and report any potential safety events.
• Provide clinical and scientific support with site training, as needed, or requested
• Where assigned, act as the primary CD liaison/point-of-contact from the team for inquiries from clinical operations, clinical research organizations (CROs), etc. Responsibilities include:
• Respond to questions from other internal and external parties regarding assigned studies and programs.
• Collaborate with Clinical Development Physicians, clinical operations, data management and other groups to conduct clinical review of study data.
• Review, analyze, present and discuss clinical study reporting documents with internal and external audiences.
• Work closely with Clinical Development Physicians, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting.
• Participate in the development and implementation of communications strategies to support existing and concluded studies.
• Lead or contribute to writing or, if applicable, writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinate submissions to scientific meetings and/or other appropriate venues or groups.

Requirements:

• Advanced degree (MBA, MPH, PharmD, PhD) preferred; 2-5 years' work experience, Data listing review experience and familiarity with standard clinical and regulatory references such as CTCAE, MedRa, etc.; Or an equivalent combination of education or experience
• Experience in the principles and techniques of data analysis, interpretation with a s