The Oncology / Hematology Clinical Science department in Global Product Development at Roche is looking to fill PhD / PharmD Fellowship positions located in Basel, Switzerland.
The duration is limited to 2 years and suitable candidates have completed their PhD / PharmD no more than 4 years ago.
The Roche Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late-stage development (Phase 2-3) clinical strategies to deliver medically differentiated therapies that provide meaningful improvement to patients.
The Postdoctoral Fellow supports the molecule / study / project team for effective and efficient Clinical Development Plan (CDP) execution.
This includes contributing to clinical documentation, supporting training of study site personnel, acting as a point-of-contact for questions and enquiries to clinical studies, conducting ongoing medical / safety data reviews, and providing clinical science input into study reporting.
Postdoctoral Fellows perform their responsibilities with guidance and direction from more experienced colleagues.
PRIMARY DUTIES AND RESPONSIBILITIES :
CDP Execution and Strategy
Provide support in developing and / or preparing clinical science information for inclusion into the CDP.
With guidance, contribute to study protocol / ICF (Informed Consent Form) writing or amendment, construct appropriate CRFs (Case Report Form) and coordinate cross-functionally.
With guidance, contribute to internal / external clinical presentations and communications (e.g., investigator meetings, study site interactions, patient information, study newsletters).
Present at appropriate internal meetings, e.g., Study Leadership Team. Contributes to abstracts, posters, content for scientific meetings.
Work with Clinical Scientists / Medical Directors / Clinical Directors and cross-functional groups to execute the Medical Data Review Plan, secure databases, data interpretation and contribute to study reporting.
With guidance, contribute to Clinical Trial Application (CTA) / Ethics Committee (EC) written interactions, briefing packs, written responses to Health Authority (HA) questions, preparations for HA interactions and clinical data input to regulatory submissions.
Liaise with study site personnel to optimize clinical trial conduct.
EXPERIENCE AND QUALIFICATIONS :
Advanced Clinical / Science Degree (PhD / PharmD) achieved no more than 4 years ago in a subject related to biosciences (e.
g., biology, biochemistry, pharmacy, biotechnology)
Ability to work and have all correspondence (verbal and written) in English and work with international colleagues based in Basel, the UK and the US
Prior clinical development experience is preferred but not required
Clear evidence of ability to assimilate information and skills and apply them with appropriate independence with clear potential and leadership qualities relative to a particular clinical trial and Study Leadership Community or equivalent
Ability to effectively integrate and contribute to a cross-functional study team in order to support the global study strategy
When does it start?
The start date of this fellowship is Q4 2022, or on availability. In case of specific preferences, please indicate your preferred starting date in your motivation letter.
All applications need to include a CV and a motivation letter .