Medical Director

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

GENERAL POSITION SUMMARY AND PURPOSE:

The Roche Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients.

The Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient execution for the assigned molecule(s)/indication(s).

The Medical Director is an entry-level PD Clinical Director position and, as such, Medical Directors are developing their knowledge of clinical studies and the pharma/biotech industry.

EXPERIENCE AND QUALIFICATIONS:

Academic/Scientific/Clinical:

M.D. Required

Relevant clinical, scientific, or clinical trial/development experience in same/similar therapeutic area 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 is preferred

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 is preferred

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

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。