Roche/Genentech Clinical Development organization is looking to develop and execute late stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients.
Requirements
- You have 6+ years academic and/or industry experience, with a primary focus in late stage clinical development; you have the ability to independently carry out the majority of their study conduct responsibilities and clear evidence of independence with respect to clinical science oversight and setting out the clinical science strategy to the clinical sub team.
- You have strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required
- You have in-depth knowledge of cross-functional teams involved in the drug development process and can integrate multiple perspectives into the CDP.
- Experienced in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements.
- You have demonstrated experience working with a Study Management Team (SMT), including training, responding to clinical study queries and support on clinical activities
- You have experience active as a co-lead in collaboration with various stakeholders, including study investigators.
- You have experience solving unique or unpredictable problems that might have an impact on the goals and objectives as set by the organization
Responsibilities
- You will provide oversight of Medical Data Review Plan execution, database lock, data interpretation and CSR and manage the process in the context of the broader CDP.
- You have the ability to set out the strategy for trial/protocol development and context in the broader CDP to GDT/LCT, ensuring appropriate data are reflected in the protocol, ICFs and CSR.
- You will establish the clinical science strategy for CTA/EC submissions, briefing packs and responses to HA questions and provide context with respect to the broader CDP to the filing team, GDT and other stakeholders.
- You can act independently with investigators and oversight of investigator meetings.
- You have experienced contributing to Therapeutic Area Expert interactions to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees)
- You have in-depth knowledge of cross-functional teams involved in the drug development process and can integrate multiple perspectives into the CDP.
- Experienced in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements.
Other
- You have demonstrated experience independently managing relationships with significant external partnerships/institutions (e.g. business alliance partners, academic institutions), in order to advance clinical programs)
- You hold a bachelor’s Degree (life sciences); Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc).
- You have a proven track record of leading and performing in a fast-paced, matrix environment; ability to work independently and influencing others with strategic decisions
- You have experience leading and mentoring others
- You have the ability to partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity.
