Clinical Trial Expert, pRED Clinical Operations

Global Development Clinical Science         ·        Little Falls, New Jersey / Welwyn, Hertfordshire / Basel, Basel-City         ·         Full time

The Position

Relocation benefits are not available for this job posting

 Who Are We:

Doing Now What Patients Need Next

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. We are courageous 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.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

In Roche Pharmaceutical Research and Early Development (pRED) we believe that rapid and innovative advances in science, technology, digital and big data are our greatest opportunities. We are passionate about improving the lives of patients and we strive for ambitious ideas, innovative approaches and urgent action. Together we create a culture defined by curiosity, responsibility and humility where our people are empowered and encouraged to bring forward extraordinary life-changing innovation. 

Pred Clinical Operations: 

Our North Star is to increase R&D Productivity and Patient Centricity. This is supported by our CO Strategy to deliver value for pRED CO and our portfolio. We aspire to be a leading edge Clinical Operations organisation that drives innovative patient-centric approaches in study design and execution, utilizes advanced analytics to drive data-driven decisions, and embeds innovative technologies into our ways of working to improve productivity and delivery of programs and studies. We strive to create an inclusive workplace where team members own their development and learning and are empowered to create and innovate.

Role Purpose: 

As part of the CO Expert Chapter the Clinical Trial Expert is accountable for a range of areas driving all phases in the execution of trial(s).  The role will require enterprise wide interconnectivity and networking and monitoring of the internal and external environment   S/he is responsible for the delivery of operational portfolio activities in support of the Programme Management Chapter within timelines, budget, quality while contributing towards the CO North Star of improving productivity and approaching study delivery from a patient centric mindset.  The Postholder will be accountable for delivering strategic components within their area of expertise that improve productivity metrics of CO.

Members of the Expert Chapter can have a wide variety of contributions which impact the delivery of pRED portfolio 

What You Will Do: 

• Ensures the Clinical Operations organisation achieves and maintains a  sustainable high level of portfolio delivery performance by, implementing and maintaining solutions that deliver on the CO North Star.  
• With a strong background in trial execution contribute to specific study strategies 
• Establishes, and maintains optimal relationships with key internal partners, stakeholder  groups, and external partners.  
• Clinical Trial Experts support the quality of CTs, by participating in audits and inspection readiness though the study lifecycle while contributing to CAPAs as required.
• Leadership role in the implementation of systems maintenance, tools and reports required across the clinical trial life cycle (eCOA, IxRS etc). Coordinating imaging and rater components of study startup, including input into requests for proposal, authoring of documents and potentially site personnel training. 
• Contribute to the development and maintenance of  relevant study oversight documentations/charters (i.e. trial risk management plan, communication plan, monitoring plan, data cleaning plan, etc.).   
• Track clinical study progress and address issues that may come up in close collaboration with study teams, affiliates, sites, and CROs as appropriate.  Collaborate with stakeholders in generating relevant reports and KPIs to monitor trial progress.  
• Establish standard approaches and provide support across the clinical portfolio in a range of area such as Investigator Meeting, Imaging, Training Materials etc

How You Will Do It:

In Clinical Operations Mindset and behaviour is as important to us as skills and capabilities

• Systems thinking
  • Connect with the bigger picture, prioritize Roche, pRED or wider team over Function and individual, apply enterprise view
  • Collaborative and creative mindset, ability to partner inside and outside Roche 
• Show and embrace agile behavior
  • Follow a logic of incrementally improving approaches and solutions (80/20 approach where applicable/ MVPs/ iterate)
  • Stand in the shoes of stakeholders and able to build strong customer relationships
  • Ability to cope with uncertainty and manage ambiguity 
• Empowerment and accountability
  • Take ownership and accountability 
  • Empower people to contribute according to their skills, capacity and interest
  • Decisions are made by the most appropriate person on the topic
  • Foster a speak-up culture
• Demonstrate a growth mindset 
  • Give, seek and receive constructive feedback
  • Openly and proactively share information, failure, ideas, experience and learnings with others
  • Drive innovations and foster the power of experimentation
• Create value in an agile organization by increasing our focus on playing the role of Visionary, Architect, Coach and Catalyst
  • As a visionary, you facilitate the creation of a bold, shared vision and higher purpose that is co-created with customers to advance a vision.
  • As an Architect, you seek value creation across the whole organisation, shaping organisational architecture and culture.
  • As a Coach you help everyone in the network build the skills and mindsets they need to succeed in an empowered system, acting as a role model and coach, with a willingness to be coached.  
  • As a Catalyst you help connect others’ work to a collective purpose, creating connections and collaboration across the organisation.

Who You Are: 

You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, patient centric and entrepreneurial spirit. 

• Have a growth mindset and are excited about learning through experience
• Feel comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments
• Have experience in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus)
• Hold a university degree or equivalent years of experience, preferred focus in life sciences
• Find passion in achieving successful outcomes by leading, coaching and inspiring others
• Want to make a difference and find excitement in innovating practices, therapeutics and processes
• Possess strong working knowledge of drug development process and respective regulations
• Feel comfortable traveling internationally based on specific program needs
• Experience in working across the clinical trial lifecycle with a solid understanding of the clinical trial environment, including ICH-GCP as well as the sequence and interdependencies of the clinical trial management
• Experienced in the clinical trial management tools and systems and their interdependencies e.g. IxRS, eCOA, centralised endpoint review (images, ECG or else), digital biomarkers etc.
• A solid grounding in business performance improvement methodologies including project conceptualisation,  situational analysis, solution design, implementation and continuous improvement.
• Ability to collaborate with a range of stakeholders in the implementation of the strategic direction for the respective early development clinical studies.
• Proven ability to contribute and/or lead specific areas of trial execution within the agreed upon timelines
• Strong interpersonal skills, written, oral communication and negotiations skills.  Must be highly organised and detail-oriented.
• Strong problem solving skills and analytical skills.

Your Location: Little Falls, Welwyn, or Basel

Roche embraces diversity and equal opportunity in a serious way. We are committed to building teams that represent a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. If you still have questions then please check our FAQs and videos on careers.roche.ch/faq

Roche is an equal opportunity employer. 

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Job Facts

Job Sub Category: Global Development Clinical Science
Schedule: Full time
Job Type: Regular
Posted Date: Jul 18th 2022
Job ID: 202207-127250

Beginning September 30, 2021, Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. 

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