1. Cross-Functional Team Membership
- Can lead and/or otherwise represents CD in sub-teams (e.g. Study Management Teams)
- relevant to assigned molecule(s)/indication(s) and helps ensure cross-functional
- integration, coordination and alignment to enable effective and efficient CD plan execution.
- Accountable for training 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.
- Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff.
- Consistently complies with all governing employment laws, regulations and company HR policies & procedures.
2. Global Clinical Development Planning
- Maintains the highest standards and levels of scientific and clinical knowledge in clinical oncology.
- Develops and provides clinical science information for inclusion into the Integrated.
- Development Commercialization Plan (IDCP), and China assessments on the pre-LIP
- molecular as part of Development Acceleration deliverables.
- Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups.
- Participates in CD strategy development and may present to various internal committees.
- Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs: 1)Seeks guidance from his/her manager, as and when needed, to ensure appropriate design and development of the CD plan; 2) Responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCPs; 3) Guides CST and relevant sub-teams in developing all CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.); 4) Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
- Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
- Communicates with HAs, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of Roche and patients. Escalates matters, as needed, in a timely manner to his/her manager or other internal partners/stakeholders.
- 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).
3. Clinical Development Plan Implementation
- Provides clinical oversight across all relevant studies and programs:
- Designs and develops clinical studies
- Collaborates with others in the development of the product safety profile
- Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials
- May participate in the identification and selection of appropriate external
investigators and sites
- Guides and collaborates with others on patient registry design and development
(including strategies for patient registry recruitment)
- Acts as CD lead in the development of study analytics and data management
plans for each study
- Represents, alongside his/her manager or others, Roche in key investigator and
other external presentations, meetings and other communications
- Ensures investigators are appropriately and thoroughly briefed, in a timely
manner, on medical/scientific matters relating to each study Acts as a medical
monitor for assigned studies
- Conducts ongoing reviews of medical/safety data
- Collaborates with relevant teams and other groups to measure and monitor study
progress against objectives and plans, including any variances, and proactively
communicate any issues, challenges and potential strategies to resolve such
- Collaborates with other groups to ensure timely and appropriate completion of
interim study reporting
- Collaborates with clinical operations to close-out clinical studies, secure data and
complete study reporting
- Accountable to ensure correct medical/scientific data interpretation for interim
and final study reporting
- Plays a lead 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 materials
- Works with regulatory and other internal partners/stakeholders in the completion
and submission of regulatory filings and other regulatory documentation.
Supports others with clinical science information and input for regulatory
submissions and other regulatory processes. Includes developing labeling and
packaging language, etc.
- Develops and 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 Roche.
- Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment.
- Responsible to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target.
- Completes and/or leads other special projects, as and when assigned, or otherwise requested.
- Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines.
Qualifications & Experience:
- M.D. with at least 3 years of clinical experience in oncology
- 3 or more years pharma-industry experience, with focusing on clinical trials.
- In-depth understanding of Phase II – III drug development, knowledge/understanding of
- Phase I & IV drug development is a plus
- Experience authoring a full clinical study protocol is preferred
- Comprehensive understanding of clinical oncology, understanding/experience on molecular biology is a plus
- Familiar with competitive activity in oncology
- Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Versed in medical aspects of GCP (Good Clinical Practice), ICH (International
- Conference on Harmonisation of Technical Requirements for Registration of
- Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
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