Global Development Leader, CVRM

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.
 

Who You Are:

(Required)

• You have an MD, MD/PhD, PhD or PharmD with demonstrated clinical, scientific and development experience in both early and late stage development.

• You have 10+ years of pharma/biotech R&D experience; including a strong level of expertise transitioning a molecule from translational/early development to late stage.

• You have a demonstrated level of experience overseeing late stage development work within the cardio metabolic space, including NASH / MASH.

• You have significant experience designing and conducting clinical trials (i.e. multiple trials) across multiple disease indications/therapeutic areas.

• You have demonstrated late stage (phase III) industry experience.

• You have demonstrated experience authoring a global clinical development plan; you have identified and created clinical development strategies that have led to label-enabling outcomes; you have demonstrated experience working with various health authorities.

• You have a 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; you are able to make trade-off decisions and determine priorities and goals

• You have demonstrated experience as a cross functional project team lead;  You have a strong level of knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
   

Preferred:

• You have prior people management experience

• You have 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.
   

The expected salary range for this position based on the primary location of San Francisco, CA is $172,200 - $471,000.  Actual pay will be determined based on grade level 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.