Lead Medical Director Product Development Cardiovascular Metabolic
Lead Medical Director Product Development Cardiovascular Metabolic
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Job Description
The Position
We advance science so that we all have more time with the people we love.
The Opportunity
Roches Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II III) clinical strategies and plans that deliver medicallydifferentiated therapies that provide meaningful improvement to patients.The Lead Medical Director makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient for the assigned molecule(s)/indication(s).
You will support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s); gathering and analyzing data and information necessary to create the CD plan.
You will collaborate with a variety of internal/external partners & stakeholders as well as multidisciplinary internal groups including business development research commercial legal etc.
You may participate in meetings reviews discussions and other interactions regarding early development/Phase I studies to provide clinical science input & guidance; including reviewing and providing late stage input to Phase I & II protocols.
You have a demonstrated understanding of Phase II III drug development.
You will take an active role with 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.
You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy strategic and annual LCP; you will work with other CST members and relevant subteams to develop CD plan components (e.g. analytics/data strategy KOL development publications strategy etc.
Who You Are:
(Required)
You have an MD/MBBS MD/PhD 3 years clinical experience; Board Certified training in areas of the Cardiovascular Renal Metabolic (CVRM) space preferred
You have significant experience working with the principles and techniques of data analysis interpretation and clinical relevance.
You have 5 years of pharma/biotech late stage clinical development experience.
Preferred:
You have demonstrated experience as a clinical development lead; you have the proven ability to use sophisticated analytical thought identify innovative approaches and act a mentor.
You have demonstrated experience working with various clinical trial designs (e.g. accelerated approval pivotal breakthrough etc)
You have sound knowledge of the pharma/biotech industry the multiple functions and roles involved in the drug development process.
You have the ability to collaborate 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
You have strong interpersonal skills: Outstanding interpersonal verbal and written communication and influencing skills: has built and cultivated important relationships both inside an organization and externally. Has proven abilities to influence internal partners and stakeholders thought leaders national advocacy organizations national standardsetting bodies and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization.
Relocation benefits are not being offered for this position.
The expected salary range for this position based on the primary location of South San Francisco CA is $233500 $433600. Actual pay will be determined based on experience qualifications geographic location and other jobrelated factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Who we are
A member of the Roche Group Genentech has been at the forefront of the biotechnology industry for more than 40 years using human genetic information to develop novel medicines for serious and lifethreatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Genentech is an equal opportunity employer and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity or expression national origin or ancestry age disability marital status and veteran status.For more information about equal employment opportunity visit ourGenentech Careers Homepage.
If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.
Required Experience:
Director
Employment Type
Full-Time
