Clinical Scientist, Ophthalmology

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 

The Roche/Genentech Product Development Clinical Science 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 Clinical Scientist 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 inquiries to the CDP at a study level, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting.

Clinical Scientists may have interactions with external stakeholders, e.g. investigators, Therapy Area Experts (TAEs) and vendors. Alongside the CSL, the lead clinical scientist may participate in external interactions with Health Authorities (HAs).

• You are able to support / help 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 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.
   

The preferred location for this position is South San Francisco, CA (USA).

Boston, MA (USA), Basel (Switzerland) or Welwyn (UK) might be considered.

Relocation benefits will not be provided.

Who You Are:
(Required)

• You hold an Advanced Clinical/Science Degree  (e.g. PhD, PharmD, Master's Degree, MPH etc).

• You have 1 - 2 years of late-stage (phase II/III) and/or early-stage (phase I/II) clinical development industry experience.

• 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 regulation.

• You have an understanding of the multidisciplinary functions involved in drug development; including therapeutic area relevant clinical trial experience or clear potential to assimilate with some support.
   

Preferred:

• You have demonstrated clinical development experience within the ophthalmology