Global Development Leader, CVRM

Genentech•Boston, MA

2d•Onsite

About The Position

Roche’s Product Development organization, structured by therapeutic area, is accountable for the design and execution of late-stage clinical development strategies and plans aimed at delivering medically differentiated therapies that demonstrate clinically meaningful benefit to patients. Roche is seeking a Global Development Lead (GDL) to provide strategic and scientific leadership for the clinical development of a new asset and/or indications within the Cardiovascular, Renal, and Metabolism (CVRM) therapeutic area. The GDL is accountable for the development of the Clinical Development (CD) strategy, the design and execution of the CD plan, and the operational oversight of clinical programs for assigned molecule(s)/indication(s). This role requires strong cross-functional collaboration to ensure alignment across regulatory, biomarker, safety, and commercial functions. The GDL also contributes to overarching therapeutic area strategies, bringing deep clinical expertise and scientific insight to inform portfolio decisions. This is a key leadership role with the opportunity to shape the development path of an innovative CVRM therapy within Roche’s pipeline. The ideal candidate will have experience in the Cardiovascular, Renal & Metabolic space; along with extensive experience in late stage drug development and managing large-scale clinical trials. 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 have demonstrated late stage clinical development expertise with relevant experience in CVMR, including the transition from early to late stages of development You have demonstrated experience as a cross functional project team lead 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 will participate in meetings, reviews, discussions and other interactions regarding early development 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 have demonstrated experience in a leadership position; you will be accountable for creating and leading a cross-functional global development team This position is based on-site in Boston, MA, USA or San Francisco, CA, USA. Relocation benefits are not being offered for this position.

Requirements

MD, MD/PhD, PhD or PharmD with demonstrated clinical, scientific and development experience in both early and late stage development
10+ years of pharma/biotech R&D experience; including a strong level of expertise transitioning a molecule from translational/early development to late stage
Demonstrated level of experience overseeing late stage development work within the cardio metabolic space, including NASH / MASH
Significant experience designing and conducting clinical trials (i.e. multiple trials) across multiple disease indications/therapeutic areas
Demonstrated late stage (phase III) industry experience
Demonstrated experience authoring a global clinical development plan
Identified and created clinical development strategies that have led to label-enabling outcomes
Demonstrated experience working with various health authorities
Proven track record of effective decision making skills; making good business decisions/exercising sound business judgment; consistently and effectively balances decisions with imperatives for ethics and efficacy; able to make trade-off decisions and determine priorities and goals
Demonstrated experience as a cross functional project team lead
Strong level of knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process
Demonstrated late stage clinical development expertise with relevant experience in CVMR, including the transition from early to late stages of development

Nice To Haves

Prior people management experience
Outstanding interpersonal, verbal, and written communication and influencing skills: have built and cultivated important relationships both inside the organization and externally; have proven abilities to influence internal partners and stakeholders, external thought leaders, 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 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 creating and leading a cross-functional global development team

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