Lead Clinical Scientist Haematology (Glofitamab)
At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
Collaborative innovation is at the very heart of the organisation and we invest more than most other companies in R&D to drive this. We have a truly differentiated portfolio across oncology, inflammation, immunology, infectious diseases, ophthalmology and neurology which covers a uniquely broad spectrum of innovative solutions for healthcare needs of the future. Projects address all stages of prevention, diagnosis and treatment of disease as well as enhancing the quality of life.
We are proud of our history bringing patients first-in-class and best-in-class products, and we continue to develop products that have breakthrough designations for high unmet needs. Roche has a long track record in bringing novel treatments to patients and we continue to explore novel investigational therapies for treating patients with hematological diseases.
Roche’s Clinical Development organisation 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. Clinical Science participates in the development of the Clinical Development (CD) plan and supports the assigned PD Medical Director/Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s).
Lead Clinical Development Scientists have primary responsibilities for supporting PD Medical Directors/Clinical Development Physicians with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting
To find out more about what it’s like to work in our Oncology and Haematology Clinical Science team in Welwyn,
Primary duties and responsibility:
Cross-Functional Team Membership:
- Participates in the relevant Clinical Science Team (CST)
- Represents CD in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s). As needed and appropriate, addresses CD study or other program-specific questions; provides updates; delivers presentations; etc.
- As requested, supports PD Medical Directors/Clinical Development Physicians with training new CST members
Global Clinical Development Planning:
- Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
- 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 Key Opinion Leaders, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
- Supports PD Medical Directors/Clinical Development Physicians, as assigned, in developing and/or preparing clinical science information for inclusion into the CD strategy for the relevant therapeutic/disease area(s), annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialisation Plan (IDCP)
- Contributes to the development of the CD plan for assigned molecule(s)/indication(s) and/or other programs
- Gathers and analyses data and information necessary to create the CD plan
Clinical Development Plan Implementation:
- Provides clinical science support for assigned studies and programs
- Participates in ongoing CST and relevant sub-team meetings, other interactions and communications
- Provides input on clinical study designs. Designs CD studies with guidance and oversight from PD Medical Directors/Clinical Development Physicians
- Conducts appropriate literature searches
- Collaborates with clinical operations, other groups and PD Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc. Helps coordinate consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)
- May develop or provide input for clinical presentation slides and other materials for internal/external meetings or clinical research (e.g: administrator training, study newsletters, communications to study sites, etc.)
- Provides additional support with site training, as needed, or requested
- Responds to questions from other internal and external parties regarding assigned studies and programs
- Collaborates with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. Works with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
- Participates in safety meetings and tracks, analyses, and reports any potential safety events
- Reviews, analyses and discusses clinical study reporting documents with PD Medical Directors/Clinical Development Physicians and various other groups
- Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
- Supports PD Medical Directors/Clinical Development Physicians with ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs for the relevant therapeutic area of assignment
Who you are:
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
To be successful within this role you will be or have:
We are looking for a professional with Bachelors Degree (life sciences preferred), advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.) and 5 or more years clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry).
- Data listing review experience is preferred
- Experience authoring experimental protocols and/or study results and conclusions
- Relevant therapeutic area experience
- In-depth understanding of Phase II – III drug development
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Comprehensive understanding of product and safety profiles
- Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- Works well within teams and is effective in collaborating with others internally and externally
- Ability to working successfully with remote teams
- Impeccable ethics
- Outstanding attention-to-detail
- Good interpersonal, verbal communication and influencing skills; can influence without authority
- Strong written communication skills
- Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
- Ability to travel
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
Good luck with your application.