Clinical Scientist Associate, Product Development Hematology (Mosunetuzumab)
Roche - South San Francisco, CA
Employment Type : Full-Time
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 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). PD Clinical 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. PD Clinical Science Associates are expected to perform their responsibilities with more independence by comparison to PD Clinical Science Assistants, 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.
PRIMARY DUTIES AND RESPONSIBILITIES:
1. 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), except the Development Working Group (DWG). 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
2. 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.
- 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 Commercialization Plan (IDCP)
- Contributes to the development of the CD plan for assigned molecule(s)/indication(s) and/or other programs
- Gathers and analyzes data and information necessary to create the CD plan
- Where applicable and assigned, supports PD Medical Directors/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 PD Medical Directors/Clinical Development Physicians in preparing for HA meeting
3. 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)
- Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by other Roche groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
- Helps coordinate the successful completion of documents with other groups
- As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
- May develop or provide input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with PD Medical Directors/Clinical Development Physicians (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
- Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs
- As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings
- Provides additional support with site training, as needed, or requested
- Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
- 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, analyzes, and reports any potential safety events
- Reviews, analyzes 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 in preparing for internal/external meetings and presentations
- Works closely with PD Medical Directors/Clinical Development Physicians, clinical operations, and other groups to close-out clinical studies, secure data and complete study reporting
- Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
- Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues or groups
- Supports PD Medical Directors/Clinical Development Physicians, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation. Writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
- 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
- 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
Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements.
QUALIFICATIONS & EXPERIENCE:
- Bachelors Degree required (life sciences preferred)
- Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
- 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
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
ABILITIES:
- Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
- Outstanding attention-to-detail
- 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
- 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.
- Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
- 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
- Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
- Works well within teams and is effective in collaborating with others internally and externally
- Ability to travel (<20%)