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Global Clinical Program Lead

13+ years
Not Disclosed
10 Dec. 7, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Global Clinical Program Lead

Company: GenMark Diagnostics, now a member of the Roche Group
Location: Carlsbad, CA (Relocation benefits not available)


About Roche

At Roche, we are transforming healthcare, pushing back the frontiers of science, and ensuring that everyone has access to the healthcare they need. Together, we embrace diversity, inclusion, and innovation, working across functions and geographies to improve patient outcomes globally.


Position Overview

As the Global Clinical Program Lead, you will serve as a strategic planning expert within the Clinical Operations Program Leadership team. You will work closely with key stakeholders to design, plan, and coordinate evidence generation activities for both registrational and non-registrational purposes. Your role will be critical in ensuring the successful development and execution of diagnostic solutions across multiple therapeutic areas, with full accountability for program progress, budgets, timelines, and risk management.


Key Responsibilities

  1. Program Strategy and Execution:

    • Proactively align with Life Cycle Teams (LCT) and Project Teams (PT) to ensure evidence generation activities are efficiently executed within Clinical Development & Medical Affairs (CDMA).

    • Lead the planning, development, and delivery of evidence generation programs, ensuring timely progress and risk management.

    • Take full accountability for program budgets, timelines, and scenario assessments, collaborating with internal teams and external stakeholders.

  2. Integrated Evidence Generation Planning:

    • Develop the Integrated Evidence Generation Plan for the products in scope, ensuring alignment with stakeholders in R&D, Regulatory Affairs, Diagnostics Partners, and other CDMA chapters.

  3. Cross-functional Collaboration:

    • Act as the key strategic partner for LCTs, working closely with sub-chapter leads and Functional Partners to ensure adequate resource allocation and support for the project teams.

    • Collaborate across regions, cultures, and time zones to foster an inclusive environment and drive joint CDMA delivery on LCT strategy.

  4. Patient and Customer-Centric Mindset:

    • Drive patient and customer-centricity by prioritizing the needs of patients and customers in every aspect of the program.

    • Partner with CDMA, R&D, and external stakeholders to deliver high-quality evidence generation outcomes.

  5. Strategic Problem Solving and Leadership:

    • Anticipate business, organizational, and regulatory issues, proposing product, process, and service improvements.

    • Solve complex problems with a broad impact on Roche's clinical development, using innovative and conceptual thinking to find solutions.

    • Communicate complex ideas effectively, ensuring buy-in from senior leadership and stakeholders.


Qualifications & Experience

  • Education:

    • Master's degree in a related field or equivalent combination of education and relevant experience.

  • Experience:

    • 10+ years of related experience with a Master’s degree or 13+ years with a Bachelor’s degree.

    • Expertise in Diagnostics Product Development and clinical operations, with a strong background in IVD molecular clinical studies (highly preferred).

  • Skills & Competencies:

    • Demonstrated leadership experience in managing global/large strategic programs or projects with considerable risk and complexity.

    • In-depth understanding of clinical development processes and the ability to solve strategic problems with broad impact.

    • Strong communication skills with the ability to influence senior-level stakeholders and drive alignment on complex projects.


Compensation and Benefits

  • Salary Range: $169,600 - $315,000 (based on experience, qualifications, and location)

  • Bonus: Discretionary annual bonus based on individual and company performance

  • Benefits: Comprehensive benefits package (details provided upon request)


Why Join Roche?

At Roche, we are at the forefront of healthcare innovation, providing transformative diagnostic solutions to improve patient care. As part of the Roche family, GenMark's ePlex system offers a sample-to-answer solution designed to address significant challenges in clinical laboratories. Join us to help shape the future of healthcare and make a meaningful impact on patients’ lives.


GenMark Diagnostics is an Equal Opportunity Employer.
We do not discriminate based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, medical condition, marital status, veteran status, or any other protected characteristic under the law.


Apply Now to take the next step in your career with Roche as a Global Clinical Program Lead!