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As the Global Clinical Program Lead, you are a strategic planning expert in the Clinical Operations Program Leadership team and are responsible for partnering with key stakeholders and CDMA (Clinical Development & Medical Affairs) functions.  You serve to deliver diagnostic solutions through successful designing, planning and coordination of high quality and efficient evidence generation activities for registrational and non-registrational purposes.

The Opportunity

You ensure proactive alignment with LCT (Life Cycle Teams) / PT (Project Teams), medical/clinical, evidence generation and execution strategies within CDMA. (40%)

You drive planning, development and delivery of evidence generation programs with full accountability for the program progress, budgets, timelines, strategic scenario assessments, proactive program risk management in partnership with cross-functional stakeholders including LCT Project Leads, Regulatory Affairs, R&D (Research & Development), Diagnostics Partners and other CDMA chapters. (40%)

You drive the development of the Integrated Evidence Generation Plan for the products in scope in partnership with internal and external stakeholders. (15%)

You collaborate with the Functional Partner (FP) and Sub-Chapter Leads (SCL), ensure adequate allocation of resources by timely communication of demands and skill set requirements in alignment with priorities of the respective CDMA Networks and Project Teams. (5%)

You may be nominated as Functional Partner and act as the key strategic partner for LCTs (primary interface of CDMA and LCTs) with subject matter expertise, providing guidance for priority, budgets and capacity coordination within chapter and/or sub-chapter;  enabling the joint CDMA delivery on the LCT strategy and collaborating with CDMA Network, Indication Leads and CDMA Chapters to align strategic decisions at the CA LT (Customer Areas Leadership Teams) and SPC (Solution Portfolio Committee).

You are accountable for the oversight of the program-level budget of assigned programs.

You drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first. You partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity.

You work across Clinical Development and Medical Affairs communities to identify mutual value and opportunities for collaboration.

Who You Are

You have a Master's degree in a related area of study, or equivalent combination of education and relevant experience.

You have 10+ years of related experience with a Master’s degree, 13+ years with a Bachelor’s degree. 

You are regarded as a technical expert in Clinical Operations. You have in-depth and/or broad expertise in Diagnostics Product Development and clinical operations specifically, or related areas.

You have experience leading/managing the lifecycle of an IVD molecular clinical study (highly preferred).

Leadership

You are able to anticipate business, organization, vendor and regulatory issues and recommend product, process and/or service improvements.

You have led global/large strategic programs or projects with considerable risk and complexity; can develop the strategy for project execution.

You can solve unique and strategic problems with broad impact on Roche's clinical development; this requires conceptual and innovative thinking to develop solutions

You can communicate complex ideas, anticipate potential objections and persuade others at senior levels to adopt a different point of view.

Locations

You are based out of Carlsbad, CA.

*Relocation Benefits are not available for this position.*

The expected salary range for this position based on the primary location of Carlsbad is $169,600 and $315,000.  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

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark 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.