Lead Clinical Scientist, Product Development, CVRM

Genentech • Daly City, CA

2d

About The Position

The Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 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 in order 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 on appropriate sub-teams and forums, leading training of study site personnel, acting as a primary point-of-contact for questions and enquiries 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 have interactions with external stakeholders, e.g. investigators, Therapy Area Experts (TAEs) and vendors. Alongside CSL, they may participate in external interactions with Health Authorities (HAs). Lead Clinical Scientists perform their responsibilities independently.
The Opportunity
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; in addition, you are able to contribute to manuscripts for submission to peer-reviewed journals.
You have demonstrated experience in trial design, protocol writing/ICF, (writing or amendment), constructing appropriate 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 and so forth) and support the medical review process.
You are experienced in (or have clear ability) 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 demonstrated experience working with external stakeholders; including, guided by the CSL, contribute to TAE interactions (e.g. advisory boards, individual engagements, steering committees) and contribute to building relationships with significant external partnerships/institutions (e.g. business alliance partners, academic institutions) in order to advance clinical studies and programs.
You have experience presenting, with guidance by the CSL, the clinical science aspects of the program at non-reference HA interactions (TC/F2F) and contribute to varied aspects of 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.

Requirements

• 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 with governing laws, regulations, guidelines and Roche SOPs on global clinical trial execution is required and some 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.
• You have a demonstrated understanding of the multidisciplinary functions involved in drug development; including therapeutic area relevant clinical trial experience or clear potential to assimilate with some support.

Nice To Haves

• You the ability to independently carry out the majority of the 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 have the ability to effectively integrate and contribute to a cross-functional study team in order to support the global study strategy
• You have proven ability to work effectively and efficiently within cross-functional teams, e.g. Study Leadership Team/CSL with therapeutic area-relevant clinical trial experience or clear ability to adapt with transferable skills
• Interpersonal skills: Strong interpersonal, 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree