Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
EXPERIENCE AND QUALIFICATIONS:
- Academic/Scientific/Clinical:
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- M.D. Required
- Therapeutic knowledge within metabolism, obesity, and diabetes with relevant clinical, scientific, and clinical trial/development experience required
- Academic/teaching background is a plus
- Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance
- Experience publishing results of a scientific study in a peer-reviewed journal ispreferred
- Regulatory: Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations ispreferred
- Duration of Experience: 2 or more years of post-graduate academic or clinical experience
- Up to 30% global travel
Key Skills and Behaviours
- Ethics: Has impeccable ethics. Demonstrates, or proven ability to demonstrate, Roche Values
- Attention to detail: Outstanding attention to detail
- Business Acumen: Has working knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. Regularly leads development of disease strategies and plans
- Organization: Can prioritize multiple tasks and goals on time, on target, and within budget
- Interpersonal skills: Good interpersonal, verbal communication and influencing skills: can influence without authority
- Writing: Strong written communication skills
- Presentation skills: Good business presentation skills; is comfortable and effective when presenting to others, internally or externally.Confident and competent when interacting with others internally and externally: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
- Negotiation Skills: Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
- Decision Making: Knows how to make trade-off decisions while balancing ethics and efficacy
- Teamwork: Strong orientation to teamwork
SPECIFIC DUTIES AND RESPONSIBILITIES:
CDP Strategy and Planning
- Participates in development of the CD plan for assigned molecule(s)/indication(s)
- Gathers and analyzes data and information necessary to create the CD plan
- Works with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
- 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
- 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)
- As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
- Maintains the highest standards and levels of 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 key opinion leaders (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 and providing late stage input into Phase I and II protocols
- Supports internal partners in transitioning new drugs/indications into Medical Affairs (MA) studies, including providing CD input for MA study protocol development.
CDP Execution
- Participates in design, development, and execution of clinical studies
- Collaborates with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials
- May guide and advise others in the identification and selection of appropriate external investigators and sites
- Participates in the development and implementation of communications strategies to support ongoing and concluded studies. Includes investigator meetings and KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
- Participates in development and delivery of 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
- Collaborates with others in development of study analytics and data management plans
- Participates in ongoing reviews of medical/safety data
- Collaborates with relevant team members 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 relevant team members to ensure timely, completion of interim study reporting
- Collaborates with relevant team members and clinical operations to close-out clinical studies, secure data and complete study reporting
- Supports other CST members to ensure correct medical/scientific data interpretation for interim and final study reporting
- Acts as a medical monitor for assigned studies
Cross-Functional Team Leadership
- Participates in the relevant Clinical Science Team (CST)
- Participates as standing or ad hoc member of sub-teams (e.g. Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
- Supports training of new CST members
- May also, as appropriate, support relevant sub-teams in assigning and training new team members
Regulatory Activities
- Supports other CST members in development of briefing packages by providing clinical science information and input
- Supports other CST members in development of responses to HA questions by providing clinical science information and input
- Participates in health authority (HA) interactions, as appropriate, with supervision from more experienced Medical Directors
- Supports other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.
Local/Global Communities
- Visible in the local site community, e.g. contributes to scientific discussion in the community. Able to provide study/program updates to the wider community
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
