Roche’s Clinical Development organization is structured by therapeutic area and is responsible for designing and executing the late development (Phase II – IIIA) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Clinical Scientist participates in development of the Clinical Development (CD) strategy and plan and supports the assigned PD Medical Director/Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s).
PD Clinical Scientists have primary responsibilities for supporting PD Medical Directors/Clinical Development Physicians with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting.
PD Clinical Scientists are expected to perform their responsibilities independently. PD Clinical Scientists are likely to have regular external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of CD, etc. They may also, alongside the PD Medical Director/Clinical Development Physician, participate in external interactions with health authorities (HAs).
1) Cross-Functional Team Leadership & Management:
- Represents CD in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s), except the Global Development Team (GDT). As needed and appropriate, addresses CD study or other program-specific questions; provides updates; delivers presentations; etc. May act as the lead CD representative on sub-teams
- As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools and other resources
- Where applicable, may lead one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff. Consistently follows all governing employment laws, regulations and company HR policies & procedures 2
2) Global Clinical Development Planning:
- Stays 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)
- Collaborates with a variety of internal and external organizations and partners, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
- May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these
- Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input into these
- Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)
- Participates, alongside PD Medical Directors/Clinical Development Physicians, in the development of clinical science contributions into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
- Develops the CD plan with the PD Medical Director/Clinical Development Physician for assigned molecule(s)/indication(s) and/or other programs Gathers and analyzes data and information necessary to build the CD plan. May also delegate such research and analysis to less experienced Clinical Scientists
- Supports PD Medical Directors/Clinical Development Physicians by providing additional mentorship and direction to CSTs and other relevant teams in developing all CD plan components (e.g. analytics/data strategy, KOL development, publications strategy, etc.)
3) Clinical Development Plan Implementation
- Provides strategic clinical science support for assigned studies and programs:
- Leads or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications
- Develops creative clinical study designs for review and discussion with PD Medical Directors/Clinical Development Physicians and/or Global Development Team Leaders (GDTLs)
- Conducts appropriate literature searches o Collaborates with clinical operations, other groups and PD 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. Helps coordinate consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)
- Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation led by other Roche groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
- Helps coordinate the successful completion of documents with other groups
- As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
- Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
- 3 or more years clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry),
- Confirmed abilities to perform Clinical Scientist responsibilities independently and with limited mentorship. Has proven, through past experience, abilities to competently lead the majority of Clinical Scientist deliverables associated with assigned clinical studies
- Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
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