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The Position
The Opportunity
At Roche Pharmaceutical Research and Early Development organisation, we transform science into medicines that change lives. You'll be embedded in a culture defined by curiosity, collaboration, and purposeful innovation — where science is rapidly transformed into life-changing therapies.
As a Biosample Project Leader, you'll play a critical role in ensuring the quality, efficiency, and impact of biosample strategies across our early development pipeline. You'll join the Regulated Bioanalysis and Biosample Operations chapter, where we collaborate across the entire drug development process — from discovery to on-market — to deliver the safe and effective therapies of tomorrow.
Your impact
* To provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme
* To ensure the appropriate level of sample quality by defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels
* To implement the biosample sourcing strategy within given projects through partnership with key stakeholders involved in project and study delivery
* To be accountable for project level oversight (from feasibility to study close-out) of laboratories/vendors and associated costs involved in biosampling activities and analyses
* To provide input to the laboratory selection process to ensure appropriate vendor selection where applicable and to actively promote knowledge sharing within Clinical Operations/BioX and across studies within a project by partnering with stakeholders
* To be accountable for the accurate and timely forecasting and management of individual project and study variable costs related to bio-sampling, in collaboration with key stakeholders
* To act as a subject matter expert e.g. within the chapter, and across BioX for specific business related topics or processes
* To mentor and coach others as required to maximise their capability and contribution to deliver high quality biosamples and to partner with cross functional parties and external vendors to communicate and train on relevant processes which underpin the laboratory operating model
Your profile
* Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi-centre clinical studies is essential and significant experience implementing clinical trials is required.
* Minimum of a degree in life sciences and previous experience in Pharma, CRO, hospitals, biobanks and biotech's in handling the operational needs for biosample management in either/both early and late stage projects and studies
* We will also consider early in careers applications relevant biopharmaceutical industry experience within clinical trial development
* Demonstrated knowledge of ICH GCP and clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
* You exhibit a growth mindset. You ask for feedback and act on it. You embrace opportunities to gain new skills and perspectives and provide honest feedback to others to help them grow.
* You are obsessed with meeting customer needs. You put yourself in your customers place and act boldly with them to bring better results to patients.
* You are able to radically simplify and prioritize for impact. You invest your time in things that accelerate progress for patients. You stop doing things that do not.
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.