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The PDC (Pharmaceutical Development Clinical) organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients.
The Lead Clinical Scientist is responsible for the clinical science aspects relative to the study team, Study Leadership Team (SLT) or project team and may lead a clinical study or other project as part of these teams in order to support effective and efficient execution of the Clinical Development Plan (CDP) for the molecule/indication. .
This includes, but is not limited to, contributing to the clinical science aspects of the CDP strategy and clinical documentation, representing the CDP on appropriate sub-teams and forums, leading training of study site personnel, acting as a primary point-of-contact for questions and enquiries to the CDP at a study level, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting.
Lead Clinical Scientists will have interactions with external stakeholders, e.g. investigators, TAEs and vendors. Alongside CSL, they may participate in external interactions with health authorities (HAs).
Lead Clinical Scientists are expected to perform their responsibilities independently.
We currently have an exciting opportunity for a Lead Clinical Scientist to join the team based in Basel, CH or Welwyn, UK to work on clinical trials in non malignant hematology.
The Opportunity
You are able to independently carry out the majority of your study conduct responsibilities.
You work with colleagues in clinical science and cross-functional groups to lead the execution of the Medical Data Review Plan, secure databases, data interpretation and contribute to study reporting (CSR).
You have experience in working independently in trial design, with protocol/ICF writing or amendment, in the construct of appropriate CRFs and the coordination of these items cross-functionally
You contribute and develop outlines for internal/external clinical presentations and communications (e.g., investigator meetings, study site interactions, patient information, study newsletters). You have experience in presenting at appropriate internal meetings (e.g. Study leadership Team, GDT) and external meetings (e.g. investigator meetings, advisory boards, steering committees)
You develop outlines for and contribute to abstracts, posters and content for scientific meetings. Contribute to manuscripts for submission to peer-reviewed journals
You have experience or clear ability, collaboratively with colleagues in clinical science and cross-functional groups, to contribute to Clinical Trial Application (CTA)/Ethics Committee (EC) written interactions, briefing packs, written responses to Health Authority (HA) questions, clinical science data/preparations for HA interactions and clinical data input to regulatory submissions. Guided by the Clinical Science Lead, you have the ability to contribute to different and varied aspects of regulatory submissions and to present clinical science aspects of the program to non-reference HAs.
You work in a collaborative environment with internal and external stakeholders and partner cross functionally with early development stakeholders especially in preclinical sciences, discovery sciences and/or developmental sciences
You are able to drive relevant discussions at the Study leadership Team.
You are able to provide day-to-day support and guidance to Clinical Science Fellows and Clinical Scientists.
Guided by the Clinical Science Lead, you have the ability to contribute to Therapeutic Area Experts, Business alliance partners, academic institutions interactions.
You are familiar with governing laws, regulations, guidelines and applicable SOPs with respect to global clinical trial execution. You have strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulation.
Who You Are:
(Required)
You hold a bachelor’s Degree focused in Biology, Biomedical Sciences and/or other relevant Life Science areas; Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc).
You have 3 or more years of early and/or late stage clinical development within the industry with demonstrated expertise in late stage R&D drug development. You have a good understanding of the multidisciplinary functions involved in drug development. You have relevant and transferable late-stage Phase 3 and/or registrational clinical trial experience in onco-hematology.
Prior experience in gene therapy or haemostasis/thrombosis is preferred.
You have strong interpersonal, verbal communication and influencing skills: you can influence without authority and you have proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally.
If you are a patient- centric Clinical Scientist with a strong analytical mindset who enjoys making an impact in an area of unmet clinical need, we would like to hear from you.
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.
Roche is an Equal Opportunity Employer.
