Clinical Development Lead, Oncology/Pathology, Companion Diagnostics

Who We Are

At Roche, we are passionate about transforming patients’ lives and we are courageous in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

 

The Opportunity

Clinical Development fills the pipeline of novel medical value diagnostic tests by designing and driving clinical development strategies for differentiated diagnostic solutions and clinical decision support that address unmet medical needs. 

 

The Clinical Development Lead, Oncology/Pathology, provides clinical leadership and acts as subject matter expert to develop the clinical development strategy for novel laboratory and digital diagnostic products in the areas of oncology/tissue-based pathology at Roche Diagnostic Solutions (RDS), with a primary focus on companion diagnostic solutions. You will define the clinical requirements for new diagnostic products, design clinical studies, lead the clinical development and validation strategy to register these products as In Vitro Diagnostics with regulatory agencies, drive medical value innovation and clinical differentiation of key products, and contribute to driving exploratory research towards novel product opportunities including digital clinical decision support.

 

This position may be based out of Tucson/AZ, Pleasanton/CA, Mannheim or Penzberg/Germany, and Rotkreuz or Basel/Switzerland, with remote work locations possible. Please note that the majority of the project teams’ activities are US West coast based (Mountain/Pacific time). The position will report to the Head of Clinical Development Oncology Pathology Lab, in Clinical Development and Medical Affairs at RDS. There will be no positions reporting administratively into this role, but the incumbent is expected to function as a leader of matrixed teams and to mentor and supervise the work of junior members of the Clinical Development team.  

 

Specific responsibilities

Serving as a Clinical Development Lead at the Director level, you will:

 

Assess the medical value of novel in vitro diagnostic (IVD) assays in the context of the proposed intended use:

• Stay abreast of pertinent developments in cancer biology through review of the biomedical and scientific literature and conference attendance.
• Maintain broad medical, clinical, and scientific knowledge of cancer diagnostics technologies and applications.
• Analyze and document the clinical, biological, and scientific rationale for development of new tissue-based IVD assays.

 

Contribute to multi-functional project teams to support regulatory clearance/approval of novel IVD assays in multiple regions worldwide:

• Apply scientific expertise in the design of analytical and clinical studies to the creation of development strategies for validating the clinical utility and performance of new IVD assays in the context of their intended uses.
• Assume primary responsibility for preparation of clinical validation plans that document agreed-upon clinical development strategies. 
• Review clinical diagnostic protocols, clinical study reports, and other documents that support clinical study planning and interpretation.
• Work with members of Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, Business, and other functions to ensure appropriate implementation of clinical development strategies.
• Contribute to pre-submission documents prepared for the FDA or other regulatory health authorities; represent Clinical Development during interactions with regulatory health authorities.

Interact directly with pharmaceutical company partners to support co-development of companion diagnostic (CDx) IVD assays: 

• Facilitate and participate in productive peer-to-peer discussions with pharmaceutical company partners.
• Ensure alignment of pharmaceutical and IVD clinical validation plans.
• Educate pharmaceutical partners about regulatory and practical issues unique to the development of CDx IVD devices. 

 

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

To be successful in this role you have to bring the following qualifications / skill set:

• MD, PhD, PharmD or equivalent degree.
• 5+ years related mechanistic cancer-focused scientific research experience.
• 3+ years (5+ years preferred) of clinical research experience with a proven ability to design clinical studies and critically evaluate study results.
• Experience in the diagnostics, medical device, or pharmaceutical industry desired with relevant disease area expertise in Oncology or Pathology 
• Experience in contributing to regulatory submissions and/or other interactions with health authorities.
• Understanding of CDx developmental strategies and regulatory requirements (preferred).
• Experience in design-control processes and in IVD devices for oncology (preferred).
• Strong communication, strategic, and problem-solving skills.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.
• Proven ability to handle multiple projects simultaneously.
• Ability and willingness to travel approximately 10-15 % of time. 

 

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Job Level:

Manager with direct reports