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 PD Clinical Science Associate participates in development of the Clinical Development (CD) plan and supports the assigned Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Clinical Scientists have primary responsibilities for supporting 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. PD Clinical Science Associates are expected to perform their responsibilities with more independence by comparison to Assistant Clinical Scientists. PD Clinical Science Associates are likely to have external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of CD, etc.
- 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.
- 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 KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
- Gathers and analyzes data and information necessary to create the CD plan
- Where applicable and assigned, supports Clinical Development Physicians in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan
- As assigned and appropriate, supports Clinical Development Physicians in preparing for HA meetings
- Clinical Development Plan Implementation
- Provides clinical science support for assigned studies and programs:
- Supports 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
- Completes and/or leads other special projects, as and when assigned, or otherwise requested
- Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines
QUALIFICATIONS & EXPERIENCE:
We are looking for a candidate with Bachelor's Degree required (life sciences preferred) or advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.) with sound clinical trial experience (must demonstrate some clinical trial experience in pharma/biotech industry) and in-depth understanding of Phase II – III drug development. You will bring:
- Data listing review experience is preferred
- Experience authoring experimental protocols and/or study results and conclusions
- Relevant therapeutic area experience
- Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence. Has demonstrated, through past experience, abilities to competently manage the majority of Clinical Scientist deliverables associated with assigned clinical studies and 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
- Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
- Good business acumen; has working knowledge of the multidisciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
- Good interpersonal, verbal communication and influencing skills; can influence without authority
- Works well within teams and is effective in collaborating with others internally and externally
- Ability to travel ( Clinical Development