Clinical Development Lead, Strategic Projects

Roche•Pleasanton, CA

60d•$186,000 - $245,500•Onsite

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The Clinical Development Lead - Strategic Projects will support CDMA Network Leads and Roles as an internal strategic clinical leader, advisor, and sparring partner for complex strategic decisions that affect the broader Roche organization. In addition, the Clinical Development Lead will be accountable for the clinical development strategy, including large studies and complex programs for new and existing programs and/or projects in the assigned indication or technology areas, such as MassSpec or other initiatives, across the Roche matrix, including but not limited to all CDMA chapters, RDS (customer areas and other functions), RIS and Pharma. The Opportunity: You will solve unique or unprecedented problems that have an impact on a part of the organization, function or chapter and across networks and impacting the larger organizational goals You will act as a coach for colleagues with less experience and helps them develop skills/expertise You will stay abreast of internal and external developments, trends and other dynamics relevant to the work of CDMA to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s) You will optimize processes to increase quality and efficiency standards You will build and maintain strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence You will build and maintain relationships with international opinion leaders, investigators and key customers, bringing external know-how in-house for the development of new products and innovative study designs You will serve as the clinical thought leader for the regulatory clinical product requirements and clinical development strategies as well as related development, review, completion and submission of regulatory filings and other regulatory documentation, with an emphasis on US FDA requirements. You will support Roche Diagnostics as clinical thought leader in external interactions with US health authorities across indication areas and technologies impacting the broader organization.

Requirements

You have a MD (MMBS or DO) with relevant expertise in the Healthcare Industry and academic institutions; preferred experience in emergency medicine
You have extensive clinical expertise within the U.S. healthcare system
You have 15+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or Medical Device Study Management in all stages of global studies, development of study protocol design, data analysis, report writing and leading matrixed teams
You have demonstrated experience leading large complex development and indication programs, with an understanding of how these might impact the broader Roche organization
You have demonstrated knowledge in applicable standards and regulations (FDA, ICH-GCP, IVDD/IVDR, MDR, NMPA regulations etc) and an understanding of the healthcare industry or equivalent academic experience
You will partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
You have the ability to travel up to 25% or more (can vary per project phase and position)

Nice To Haves

Outstanding business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s product development process, e.g., clinical operations, biostatistics, regulatory, commercial, etc. and can proactively integrate multiple perspectives into the clinical development process and strategy for best end-results
You have the ability to work independently and have demonstrated analytical skills and strategic mindset
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 standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization.
You have experience working a fast-paced, matrix organization

Responsibilities

Solve unique or unprecedented problems that have an impact on a part of the organization, function or chapter and across networks and impacting the larger organizational goals
Act as a coach for colleagues with less experience and helps them develop skills/expertise
Stay abreast of internal and external developments, trends and other dynamics relevant to the work of CDMA to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
Optimize processes to increase quality and efficiency standards
Build and maintain strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence
Build and maintain relationships with international opinion leaders, investigators and key customers, bringing external know-how in-house for the development of new products and innovative study designs
Serve as the clinical thought leader for the regulatory clinical product requirements and clinical development strategies as well as related development, review, completion and submission of regulatory filings and other regulatory documentation, with an emphasis on US FDA requirements.
Support Roche Diagnostics as clinical thought leader in external interactions with US health authorities across indication areas and technologies impacting the broader organization.