Lead Clinical Scientist

GENERAL POSITION SUMMARY/PURPOSE:

Genentech’s Research and Early Development (gRED) Early Clinical Development (ECD) organization is responsible for developing and executing early development clinical strategies and plans to provide proof-of-concept data with respect to safety, efficacy, and the utility of biomarkers for gRED new molecular entities. The Lead Clinical Scientist (E4A/SE6 level) participates in development of clinical strategies for assigned molecule(s)/indication(s) and is responsible for developing and effective and efficient execution of the Clinical Development Plan (CDP) for one or more molecules. Lead Clinical Scientists are expected to perform their responsibilities independently, have core knowledge of the CS function to enable increased participation in department level initiatives, and may contribute to complex projects with supervision.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

Cross-Functional Team Leadership & People Management

• Contributes as a standing member of the Clinical Science Sub-Team (CST), is an ad hoc member of the Core Team, and may represent CS on other relevant sub-teams. Presents and leads discussions relating to clinical data or protocol execution. Helps cross-functional team members synthesize/contextualize clinical data to facilitate discussion and decision making. May independently lead working groups and/or subteam initiatives in support of protocol, disease area, or CDP.

• Represents Clinical Science (CS) on Execution Team(s) of assigned molecule(s)/indication(s), and ensures cross-functional integration, coordination and alignment in protocol development and execution decisions and documentation to enable effective and efficient CDP execution. Trains other study team members (internal and/or external personnel) on study protocol

• Contributes to CDP and development of long-range strategy for assigned programs

• Drives authoring, review and team decisions required to develop study protocols, ICFs, and study start-up documents documents requiring clinical expertise (eg, development/updating of CRFs, monitoring plans, study registry and disclosure etc.).

• Conducts medical data review. Collaborates with the Visual Analytics Manager to tailor visualizations and summaries of Spotfire’s clinical and safety data required for ongoing medical data review. Collaborates with Data Management to ensure all queries submitted to sites by CS have been appropriately addressed.

• Processes and conducts regular review and analysis of protocol deviations.

• Drafts clarifications to protocols and protocol amendments as needed, and ensures any protocol amendments and corresponding ICFs and study related documents are completed/updated as needed.

• Responsible for ensuring the completeness and quality of CS documents in the trial master files (TMF).

• Primary POC for protocol-related inquiries from internal colleagues and external sites. Liaises with Medical Monitor, CST Lead, and other CS team members to address inquiries and drive protocol-level decisions and deliverables.

• Addresses queries or triages as appropriate. Trains study site personnel on protocol execution. May oversee vendors contracted for protocol deliverables.

• May author, in collaboration with relevant team members and/or support functions, clinical sections of regulatory documents, or responses to healthy authority (HA) or ethics committee inquiries.

• Collaborates cross-functionally to develop simplified/novel/fit-for-purpose presentation of study data.

• Contributes to publications for peer-reviewed journals and/or scientific abstracts for submission to national and international scientific conferences.

• Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.

• Collaborates with biostatistics to develop and QC data tables, listings, and figures and develops data-driven. study- specific analyses, as appropriate.

• Collaborates with Clinical Safety to identify and track any potential safety events within a given study and/or across studies.

• Identifies the need for revision and/or development of new eCRFs in response to incoming study data and/or changes in clinical practice or clinical protocol requirements. Writes eCRF Completion Guidelines for novel eCRFs.

• Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.

• Assists with portfolio enabling work, if requested.

• May assist with clinical evaluation for due diligence activities for in-licensing and development opportunities, if requested.

• May mentor and/or train new Clinical Scientists, Interns, or Rotation candidates.

• Supports or leads business and process improvement goals and initiatives.

• Supports or leads the development/maintenance of CS resources and procedural documents/SOPs.

SELECTION CRITERIA:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

• Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.)

• 4 or more years pharma/biotech industry experience preferred

• 4 or more years experience with clinical trials preferred

• 2 or more years relevant therapeutic area experience preferred

• Has experience working in complex matrixed setting(s)

• Experience with cross-functional authoring full clinical trial protocols

• Experience publishing clinical trial results in peer-reviewed journals

• In-depth understanding of drug development

• Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance

• Comprehensive understanding of product and safety profiles

• Well-versed in medical aspects of GCP (Good Clinical Practice) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

ABILITIES:

• Proven abilities to perform CS responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of CS deliverables associated with assigned clinical studies

• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, gRED values

• Outstanding attention to detail

• Strong business acumen; has knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results

• Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance

• Excellent 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

• Outstanding written communication skills

• Proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally

• Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points

• Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc.; stays focused and on-point, is able to raise problems or challenges in a productive and mature manner

• Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end-results

• Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively identifies and addresses important factors affecting clinical trial design and execution

• Aptitude or proven ability to manage others (can lead and motivate direct reports, prioritize and oversee their work through to successful outcomes, and support their career development efforts)

• Ability to travel globally (10%; variable based on project assignment)

Job Level: