Roche’s 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 medically-differentiated therapies that provide meaningful improvement to patients.
The Senior Medical Director leads development of the Clinical Development (CD) strategy and plan and is responsible for ensuring effective and efficient execution for the assigned molecule(s)/indication(s). Senior Medical Directors are expected to perform their responsibilities independently, and effectively lead multiple projects. Our late stage, clinical development organization is structured by therapeutic area and is responsible for developing and executing the late development clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.
You will lead, delegate and be responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s); you will represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups; you will be responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
You will collaborate 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.
You 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
You will lead health authority (HA) interactions, including the development of briefing packages by providing clinical science information and input; you will take a lead role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation; providing clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.
You will be accountable for training new CST members
This position is based on-site in San Francisco, CA (preferred); Boston, MA; Basel, CH; Welwyn, UK.
Relocation benefits are not being offered for this position.
Who You Are:
(Required)
You are a Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD trained Neurologist
You have 6+ years of pharma/biotech R&D experience and/or is recognized as an expert in your field; you can effectively contribute to pipeline strategy and lead cross-functional teams.
You have late stage experience within the Neurology space and have worked with various health authorities.
You have demonstrated the ability to work with pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships
You have significant experience designing and conducting clinical trials (i.e. one or more trials)
You have demonstrated experience in late stage development; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act a mentor
You have demonstrated the ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings
You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance, and demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols, health authority documents)
You have outstanding communication skills in both long-form scientific presentation and short-form communication of complex scientific topics
You have demonstrated 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
You are experienced working with various clinical trial designs
Preferred:
You have demonstrated clinical experience within multiple sclerosis
You have leadership experience.
You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: have built and cultivated important relationships both inside and outside of the organization and externally; have proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties.
You have the proven ability to use sophisticated analytical thought, identify innovative approaches and act as a mentor.
You have demonstrated the abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization.
The expected salary range for this position based on the primary location of South San Francisco, CA is $253,700 - $471,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related 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.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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.
