Roche
Healthcare
MedicalDirector-CVM
Neural analysis suggests this role is
optimal for Director candidates.
“Medical Director - CVM at Roche. Skills: Therapeutic knowledge, Clinical development, Regulatory affairs. Participate in development of CD plan. Gather data for CD plan”
Industry & Context.
Data analysis; Data interpretation; Decision making; Trade-off decisions; Problem identification; Challenge identification; Strategy development
Up to 30% global travel
What They're Looking For.
Must Have
M. D. Required, Therapeutic knowledge within metabolism, obesity, and diabetes, Relevant clinical, scientific, and clinical trial/development experience, Experience working with data analysis principles, Experience working with data interpretation principles, Experience working with clinical relevance principles, 2 or more years of post-graduate academic or clinical experience, Impeccable ethics, Outstanding attention to detail, Working knowledge of pharma/biotech industry, Working knowledge of drug development process, Regularly leads development of disease strategies, Regularly leads development of disease plans, Prioritize multiple tasks and goals on time, Prioritize multiple tasks and goals on target, Prioritize multiple tasks and goals within budget, Good interpersonal skills, Good verbal communication skills, Good influencing skills, Written communication skills, Good business presentation skills, Comfortable and effective when presenting to others, Confident and competent when interacting with others, Knows how to make trade-off decisions, Balances ethics and efficacy in decisions, Orientation to teamwork
Nice to Have
Academic/teaching background is a plus, Experience publishing results of scientific study, Knowledge of medical aspects of GCP, Knowledge of medical aspects of ICH, Knowledge of medical aspects of FDA, Knowledge of medical aspects of EMA, Knowledge of other relevant guidelines, Knowledge of other relevant regulations
What You'll Do.
Participate in development of CD plan
Gather data for CD plan
Analyze data for CD plan
Develop CD plan components
Develop and provide budget requirements
Develop and provide resource requirements
Stay abreast of internal developments
Stay abreast of external developments
Participate in competitive intelligence
Participate in market assessment activities
Maintain scientific knowledge
Maintain clinical knowledge
Collaborate with clinical investigators
Collaborate with clinicians
Collaborate with scientists
Collaborate with key opinion leaders
Collaborate with multidisciplinary internal groups
Provide clinical science input for Phase I/II protocols
Provide late stage input for Phase I/II protocols
Support transition of new drugs into Medical Affairs
Provide CD input for MA study protocol development
Participate in design of clinical studies
Participate in development of clinical studies
Participate in execution of clinical studies
Collaborate in development of product safety profiles
Collaborate in development of clinical sections of investigator
Collaborate in development of presentations
Collaborate in development of other materials
Guide identification of external investigators
Advise identification of external investigators
Guide selection of external investigators
Advise selection of external investigators
Guide selection of external sites
Advise selection of external sites
Participate in development of communications strategies
Participate in implementation of communications strategies
Participate in investigator meetings
Participate in KOL interactions
Participate in advisory boards
Participate in major medical meetings
Participate in congresses
Participate in publications development
Participate in development of key presentations
Participate in delivery of key presentations
Convey CD perspective in presentations
Provide updates on strategies
Provide updates on plans
Provide updates on activities
Present at advisory boards
Present at external forums
Represent Roche at external forums
Collaborate in development of study analytics
Collaborate in development of data management plans
Participate in ongoing reviews of medical data
Participate in ongoing reviews of safety data
Collaborate to measure study progress
Collaborate to monitor study progress
Communicate issues proactively
Communicate challenges proactively
Communicate potential strategies proactively
Collaborate to ensure timely completion of interim study
Collaborate to ensure timely completion of study close-out
Collaborate to ensure timely completion of data securing
Collaborate to ensure timely completion of study reporting
Support correct medical data interpretation
Support correct scientific data interpretation
Act as medical monitor for assigned studies
Participate in relevant Clinical Science Team
Participate as member of sub-teams
Support cross-functional integration
Support cross-functional coordination
Support cross-functional alignment
Support training of new CST members
Support sub-teams in assigning new team members
Support sub-teams in training new team members
Support development of briefing packages
Support development of responses to HA questions
Participate in health authority interactions
Support completion of regulatory filings
Support submission of regulatory filings
Provide clinical science information for regulatory submissions
Provide clinical science input for regulatory submissions
Provide clinical science information for regulatory processes
Provide clinical science input for regulatory processes
Develop label language
Develop packaging language
Contribute to scientific discussion in local site community
Provide study updates to wider community
Provide program updates to wider community
How You'll Work.
Team & Collaboration
Cross-functional teams; Multidisciplinary internal groups; Clinical Science Team; Sub-teams; Cross-functional integration; Cross-functional coordination; Cross-functional alignment
Communication Scope
Verbal communication; Written communication; Business presentation; Interpersonal skills; Influencing skills; Presentation skills; Interacting with others; Conveying perspective; Providing updates; Scientific discussion
Process & Methodology
CD plan development, CD plan execution, Study management, Resource requirements, Budget requirements
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position **EXPERIENCE AND QUALIFICATIONS:** * **Academic/Scientific/Clinical:** * 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 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 *
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