Senior Clinical Scientist, Product Development (Lupus)

Job content

• Cross-Functional Team Leadership &Management
• Participates in the relevant Clinical Science Team (CST)
• Represents CD in sub-teams (e.g. Study Management Teams) relevant to assigned molecule(s)/indication(s). 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 requested, or otherwise appropriate, trains new CST members
• May also, as appropriate, support relevant sub-teams in assigning and training new team members
• As appropriate, participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources
• As appropriate, coaches and guides less experienced Clinical Scientists
• Where applicable, may manage one or more direct reports and is, in such instances, accountable for hiring, training, developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures2. 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)
• Participates in competitive intelligence and/or other market/industry assessment activities and projects. Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, businessdevelopment, commercial operations, legal, etc.
• May serve as the CD representative for early development, post-marketing and/or diagnostics projects, and/or as CD representative to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)
• Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)
• Provides clinical science contributions into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
• As assigned/applicable, develops the CD plan for assigned molecule(s)/indication(s) and/or other programs
• Provides additional guidance and direction to CSTs and other relevant teams in developing all CD plan components (e.g. analytics/data strategy, KOL development, publications strategy, etc.)
• Where applicable, develops and provides information and input to other groups regarding budget/resource requirementsnecessary to implement and execute the CD plan
• Participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients3. Clinical Development PlanImplementation
• Provides strategic clinical science support for assigned studies and programs:o Leads or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communicationso Develops innovative clinical study designso Conducts, or delegates, appropriate literature searcheso 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 dosemodification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc. Helps ensure consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)o Writes, or oversees others in development of, additional clinical science documentation and/or clinical science input into other documentation managed by other Roche groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)o Oversees the successful completion of documents with other groupso As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentationo Collaborates with clinical operations to develop and implement the overall data quality plano Develops, or otherwise delegates development of clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)o Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programso As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetingso May provide additional support with site training, as needed, or requested; or, delegates these responsibilities to other Clinical Scientistso Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.; or, delegates these responsibilities to otherClinical Scientistso Responds to, or guides others in their responses to, questions from other internal and external parties regarding assigned studies and programso Conducts or oversees others in conducting clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. and working with others to develop and communicate relevant medicalinquirieso Plays a leadership role in safety meetings; identifies and escalates any potential safety eventso Participates in senior-level discussions and reviews of clinical study reporting documentso Ensures appropriate items are included in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments; or, delegates these responsibilities to other ClinicalScientistso As appropriate, responds to HA inquirieso Works closely with PD Medical Directors/Clinical Development Physicians, clinical operations and other groups to close-out clinical studies, secure data and complete study reportingo Plays a leadership role in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materialso Delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Rocheo Writes or oversees others in developing abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinating reviews with internal partnersand stakeholders. Ensures timely coordination of submissions to scientific meetings and/or other appropriate venues or groupso Plays a leadership role in completion and submission of regulatory filings and other regulatory documentation.Writes sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
• Works with others to drive ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs for the relevant therapeutic area of assignment
• Completes and/or leads other special projects, as and when assigned, or otherwise requested
• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines