Clinical Program Leader
Clinical Program Leader
At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
As a valued partner for effective decision-making, project, and clinical study execution, the Strategy Portfolio & Clinical Operations Function (SP&CO) maximizes Pharma Research and Early Development’s (pRED) portfolio value by enabling teams to progress projects efficiently & effectively, providing objective analysis and strategic context and by executing the clinical studies that bring medicine to patients.
The Clinical Program Execution (CPEx) organization is comprised of a diverse team of passionate leaders in operational strategy bringing excellence in clinical study execution within Pharmaceutical Research & Early Development (pRED). CPEx sits within Strategy, Portolio, and Clinical Operations and is a fit-for-purpose, integrated organisation with a DTA (Discovery & Translational Medicine Area)-aligned operating model.
As a critical team member of the CPEx organization, The Clinical Program Leader (CPL) drives the program level operational strategy and provides leadership to all operations functions assigned to pRED clinical projects. The CPL reports to the Senior Clinical Program Leader for their assigned DTA and provides coaching and operational strategic guidance to Clinical Research Study Leaders in collaboration with Study Lead Team Leads.
Acting as a key partner with internal stakeholders (Protect Team Leads, Translational Medicines Leads), Global Project Manager, Clinical Pharmacologists, Biomarker Leaders, etc.) you will ensure the effective and successful implementation of the early Clinical Development Plan (CDP). Furthermore, you will make informed and risk based decisions involving operational execution and delivery to achieve business objectives. To support a culture of innovation and continuous learning, you will serve as a change champion to foster continuous improvement and organizational transformation.
Key job responsibilities
- You serve as a leadership team (LT) member on the Neuroscience and Rare Diseases DTA (NSRD DTA) team within CPEx
- You are responsible & accountable for all operational activities within a project and ensures these activities are performed according to quality, schedule and cost standards
- You develop and lead the operational strategy of the Clinical Development Plan (CDP) for assigned projects in partnership with the NSRD DTA
- You develop, validate, and pressure test timeline scenarios and budget estimates using various tools & modeling simulations in support of governance decisions (Clinical Candidate Selection, Entry into Human, Entry into Phase 2)
- You represent Clinical Ops as core & contributing member of the Project Team and the Clinical Expert Team
- You provide strategic oversight to CRO partners at the program level
- You conduct systematic risk evaluations and operational assessments of protocols in collaboration with Study Management Team Leads (SMTL)
- You are responsible for budget forecasting & providing resource demand for assigned projects
- You represent Clin Ops on Due Diligence efforts and provide operational strategic input to CDP
- You may serve as Business Lead, BPO, or core contributor for Clin Ops Strategic Initiatives
- With 10 years ‘experience in clinical research experience, you own a proven track record in project or study leadership roles across multiple global programs/studies in a pharma, biotech, or CRO setting is required
- You have a deep understanding of clinical drug development throughout a product’s life cycle with particular focus on Phase I and Phase II studies in neuroscience
- A background in Neuroscience or Rare diseases in diverse range of patient populations is a clear asset for this role but not a requirement.
- As a leader, your project & program management skills will serve, inspire and motivate others within the organization. Line management experience and PMP certification are both a plus
- You will negotiate challenging timelines/enrollment scenarios with stakeholders
- Driving accountability with team members & stakeholders, you ensure successful delivery and operational execution of clinical studies
Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.
Please specify your preferred location while submitting your application between Basel, Welwyn or New-York.
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
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Roche is an equal opportunity employer.