Clinical Program Leader

Roche•Tucson, AZ

About The Position

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. The Position Key Accountabilities: The key accountabilities for this position include, but are not limited to: Ensure proactive alignment with LCT (Life Cycle Teams) / PT (Project Teams), medical/clinical, evidence generation and execution strategies within CDMA. 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. Drive the development of the Integrated Evidence Generation Plan for the products in scope in partnership with internal and external stakeholders. In collaboration 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. May be nominated as Functional Partner acting 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). Accountable for the oversight of program-level budget of assigned programs. Locations: US, Germany, UK (Tuscon, Penzberg, UK)

Requirements

Bachelor degree in scientific discipline or related field required.
10+ years of experience in clinical trials is required
Experience in diagnostics, biotechnology and/or pharmaceutical clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs.
Demonstrated ability to work collaboratively across all levels of an organization and to lead influentially.
Ability to operate and lead efficiently in a heavily matrixed and multi-site organisation
Understands the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.).
Excellent knowledge of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH-GCP, Federal guidelines, GMP, GLP, ISO, etc.)
Ability to initiate and effectively lead change efforts, and ensure people accountability.
Strong communication, presentation, and interpersonal skills and ability to build close working relationships across the organization and with alliance partners.

Responsibilities

Plans and executes clinical trial programs for assigned area of focus for registrational trials and/or non-registrational and/or research studies for US or outside US.
Responsible for the implementation and maintenance of the clinical trial-related policies, as well as processes and procedures related to the Design Control requirements.
Provides input to budgets.
Identifies opportunities to reduce costs.
May manage portions of larger area(s) budget.
Accountable for ensuring that budgets and schedules are met.
Provide technical expertise to staff for the development of clinical trial documents and records (protocols, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, etc.) and trial conduct.
Maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensure operational excellence.
Acts as liaison with the Clinical and Medical groups within RMS and the Diagnostics division and other partners to identify and implement collaborative studies, regulatory activities, and other programs.
Responsible for adhering to regulations, guidelines and departmental standard operating procedures.
Manages relationships with international opinion leaders, investigators and key customers.
Manages internal and external resources to support scheduled studies.
Represents the department at cross functional project teams and Business Unit level.
Implements of global study support strategies and initiatives.
Regularly interacts with executive management on work of area(s) that impacts larger organizational goals.
Responsible for establishing plans for area with input from more senior management.
Fully accountable for the results and achievements of the area.
Works independently and is highly autonomous.
Serves as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
Other duties as assigned by management.