Clinical Development Lead, Strategic Projects

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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.
   

Who You Are:
(Required)

• 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)
   

Preferred:

• 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
   

This position is based onsite in Pleasanton, CA.
Relocation benefits are not being offered for this position.
 

The expected salary range for this position based on the primary location of Pleasanton, CA is $186,000 - $245,500.  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

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche 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.

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