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

Study Lead, pRED Clinical Operations

In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines.

Together we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

In Clinical Operations (CO), we aspire to be a leading edge organization 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 drive productivity and delivery of programs and studies. We strive to create a workplace where team members own their own development and learning and are empowered to create and innovate.

Job mission

As part of the CO Programme Cluster, the Study Lead provides leadership for one or more global Study Management Teams responsible for delivering internally managed as well as outsourced First in Man through Proof of Concept studies. You are accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines.

Your impact

You lead global study teams to deliver clinical studies according to the expected and specified quality standards, within timelines and budget by the following:

Driving study strategy through designing study strategy, integrating the patient voice,driving diversity in enrollment, reviewing / contributing and evaluating executability of study protocols, country selection and data delivery plans, in partnership with cross-functional stakeholders.

Leading study teams by providing operational expertise (creating / driving study timelines, milestones and budget) and thought leadership to global teams that are accountable for delivering clinical studies.

Managing risk and compliance by identifying, managing and mitigating risks and issues while ensuring the study team is trained on and adheres to all appropriate standards, including ICH/GCP, SOPs and other regulations.

Managing vendor performance by providing direction and oversight for outsourced activities to ensure CRO and vendor delivery against contracted scope of work.

Innovating and championing change by driving process improvement, implementing new technologies and participating in supplemental non-project work - e.g., participating in cross-functional initiatives, attending and participating in conferences, ad boards.

Your profile

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 sound 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 processes and respective regulations

Feel comfortable traveling internationally based on specific program needs

Advocate for what you and your team need to succeed

Have a sound understanding and appreciation of the scientific basis for different study types, with the ability to question scientific rationale and practical aspects of protocol design

Location

Welwyn, UK / Basel, Switzerland

This position is office-based and candidates must be able to commit to spending a majority of working time in the office (refer to local site policies).

Our commitment

Roche commits to recognising talent and aptitude. We prioritize encouraging and supporting our employees in their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career.

We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

 

 

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.