Senior Medical Director, Late Stage Development, Rheumatology

Genentech • Boston, MA

31d

About The Position

By applying our expertise in immunology, Roche/Genentech continues to deliver on its commitment to address unmet needs for patients with kidney diseases. Our industry-leading pipeline continues to make advancements to deliver meaningful options for those affected. Genentech's Late Stage, Rheumatology team is expanding with a Senior Medical Director opportunity. As a leader, you will be instrumental in advancing our commitment to patient care . It is a high-impact, visible role at a time of significant opportunity within the Rheumatology Disease area. 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 Who You Are: (Required) You have an MD (MBBS) or MD/PhD; with at least 4 years of clinical, scientific and/or development experience. Board Certified Rheumatologist highly preferred; physicians with substantial experience in rheumatology drug-development may be considered. 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 experience developing global clinical development plans and have worked with various health authorities. You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance. You have demonstrated 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 e xperience publishing results of a clinical trial in a peer-reviewed journal is required

Requirements

• MD (MBBS) or MD/PhD; with at least 4 years of clinical, scientific and/or development experience
• Board Certified Rheumatologist highly preferred; physicians with substantial experience in rheumatology drug-development may be considered
• 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
• Experience developing global clinical development plans and have worked with various health authorities
• Significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance
• Demonstrated ability to work with pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships
• Significant experience designing and conducting clinical trials (i.e. one or more trials)
• Demonstrated experience in late stage development; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act a mentor
• Experience publishing results of a clinical trial in a peer-reviewed journal is required

Nice To Haves

• Strong drug development experience in SLE and/or other Rheumatologic diseases
• Strong level of knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process
• Leadership experience
• 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

Responsibilities

• Lead, delegate and be responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s)
• Represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups
• Responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
• 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
• 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
• Lead health authority (HA) interactions, including the development of briefing packages by providing clinical science information and input
• 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
• Accountable for training new CST members

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees