Genentech ยท 3 days ago
Senior Clinical Research Scientist
Boston, MA
Full-time
Onsite
Senior LevelGenentech is a leading biotechnology company focused on developing and executing late stage clinical strategies. The Senior Clinical Research Scientist will lead the clinical science aspects of the Clinical Development Plan and work closely with various stakeholders to support late stage programs.
BiotechnologyLife ScienceManufacturing
Responsibilities
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 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)
Qualification
Required
You hold a bachelor's Degree (life sciences); Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc)
You have extensive 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 subteam
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
Preferred
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 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 leading and mentoring others
You have experience solving unique or unpredictable problems that might have an impact on the goals and objectives as set by the organization
You have the ability to partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
You have demonstrated Interpersonal skills: Strong verbal communication and influencing skills; can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
Founded in 1976
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
CEO
Michael Laird
Vice President
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