Overview
The Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing late stage (Phases 2-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients. The Lead Clinical Science position is responsible for the clinical science aspects relative to the study team, Study Leadership Team (SLT) or project team and may lead a clinical study or other project as part of these teams to support effective and efficient execution of the Clinical Development Plan (CDP) for the molecule/indication. This includes contributing to the clinical science aspects of the CDP strategy and clinical documentation, representing the CDP in sub-teams and forums, leading training of study site personnel, acting as a primary point-of-contact for questions to the CDP at a study level, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting. Lead Clinical Scientists will interact with external stakeholders (e.g., investigators, Therapy Area Experts (TAEs) and vendors) and may participate in interactions with Health Authorities (HAs). Lead Clinical Scientists perform their responsibilities independently.
Responsibilities
* You are able to contribute and develop outlines for internal/external clinical presentations and communications (e.g., investigator meetings, study site interactions, patient information, newsletters); you have the ability to present at internal meetings (e.g., Study Leadership Team, Global Development Team) and external meetings (e.g., investigator meetings, advisory boards), abstracts, posters and content for scientific meetings; you can contribute to manuscripts for submission to peer-reviewed journals
* You have demonstrated experience in trial design, protocol writing/ICF (writing or amendment), constructing CRFs and coordinating cross-functionally; you understand the integration of individual (pivotal) studies into the broader CDP context, including alignment with the Clinical Science Team (CST)
* You have demonstrated experience and the ability to conduct and design protocol medical reviews; you will oversee the clinical data review (data analysis, cleaning, etc.) and support the medical review process
* You are experienced in contributing to CTA/EC written interactions, briefing packs and responses to HA questions; contribution to the strategic approach and cross-functional coordination
* You have experience working in a collaborative environment and interacting with external stakeholders; including, guided by the CSL, contributing to TAE interactions (e.g., advisory boards, individual engagements, steering committees) and building relationships with external partners/institutions to advance clinical studies and programs
* You have experience presenting the clinical science aspects of the program at regulatory interactions (non-reference HA interactions) and contributing to regulatory submissions
This position is located in San Francisco, CA (US), Boston, MA (US), Welwyn (UK), or Basel (CH).
Relocation benefits will not be provided.
Qualifications
* Required
* You hold an Advanced Clinical/Science Degree (e.g., PhD, PharmD, MSN, MPH, etc)
* You have 3+ years of clinical development industry experience with demonstrated ability in late stage R&D drug development
* You have 3+ years of experience designing and conducting medical data reviews (MDRs)
* You have demonstrated knowledge of governing laws, regulations, guidelines and Roche SOPs on global clinical trial execution and some knowledge of medical aspects of GCP, ICH, FDA, EMA and other relevant guidelines and regulations
* You have a demonstrated understanding of multidisciplinary functions involved in drug development, including therapeutic area relevant clinical trial experience or clear potential to assimilate with some support
Preferred
* You have the ability to independently carry out the majority of study conduct responsibilities
* You have experience conducting large clinical outcome trials
* You have experience in endocrinology, diabetes, cardiology, gastroenterology, hepatology, immunology and/or other relevant disease areas
* You can effectively integrate and contribute to a cross-functional study team to support the global study strategy
* You have proven ability to work effectively within cross-functional teams, e.g., Study Leadership Team/CSL with therapeutic area-relevant trial experience or transferable skills
* Interpersonal skills: strong interpersonal, verbal communication and influencing abilities; ability to influence without authority and build relationships with key partners and stakeholders, internally and externally
The expected salary range for this position based on the primary location San Francisco, CA is $141,000 - $262,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance.
This position also qualifies for the benefits detailed at the link provided below.
Benefits
Genentech is an equal opportunity employer. It is our policy to employ, promote, and otherwise treat employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including discrimination on the basis of protected veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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