We are looking for a talented (Senior) Clinical Scientist to join our Rare Blood Blood Disease team.
The role will include a global filing opportunity.
Roche’s Clinical Development organization is structured by therapeutic area and is responsible for
developing and executing the late development (Phase II – IIIA) clinical strategies and plans to deliver
medically-differentiated therapies that provide meaningful improvement to patients. The (Senior)
Clinical Scientist participates in the development of the Clinical Development (CD) strategy and plan
and supports various deliverables for effective and efficient CD plan execution for the assigned
molecule(s)/indication(s).
Roche is seeking a Senior Clinical Scientist with significant drug development and clinical trials
experience to help contribute to the late-stage clinical development of treatments for rare blood
disorders.
The Senior Clinical Scientist assists the Clinical Science Leader (CSL) in all areas of a project that
include but is not limited to study planning, protocol development, medical monitoring, data
interpretation, and documentation as well as annual regulatory documents update.
Maintains scientific and clinical knowledge in the specific therapeutic and disease
area(s) of assignment
Collaborates with a variety of internal and external partners and stakeholders, such
as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary
internal groups, including other groups in PD, research, business development,
commercial operations, legal, etc.
You assist timely and scientifically the CSL in the development of a Clinical
Development Plan.
You ensure that GCP, Clinical Operating Guidelines, and Standard Operating
Procedures are followed within PDC.
You liaise and communicate with other functions including operations, biometrics,
safety, regulatory affairs and co-ordinate the clinical efforts on the project-related
issues.
You assist timely and scientifically in the preparation of all documents for regulatory
authorities.
You ensure correct data interpretation and appropriate content of interim and Final
Study Reports as well as of PDC documents submitted for approval.
You collaborate with other functions and assist in the preparation of abstracts,
posters, and oral communication for scientific meetings.
You will have close and frequent, but remote interactions with other members of the
global team located in the UK and in South San Francisco.
Who you are
We are looking for a professional with a PhD or equivalent, experience ideally in Oncology /
Hematology (RBD is a plus) and industry experience.
You will bring:
You have at least 5 years of experience in Clinical Trials within drug development
within the Pharma Industry/Biotech
You have strong clinical research experience in working on a clinical team (or
equivalent).
You are a strong team player, you have the ability to get ‘up to speed’ on a new
indication or on a new program.
You are able to evaluate, interpret and synthesize scientific data, you can verbally
present and critically discuss clinical trial data in internal and external meetings.
You have excellent verbal and written communication skills in English. You have an
international perspective.
Beyond this you have proven managerial skills – you can accurately assess strengths
and develop needs of employees, provide challenging assignments and opportunities
for development.
Please note that depending on your experience and qualifications, we may offer one of these titles:
Senior Clinical Scientist/Clinical Scientist.
Roche is an equal opportunity employer.