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. 

The Opportunity

The Therapeutic Data Manager Lead will contribute to the company's Clinical Data Management organizational and Therapeutic Area Data strategies, lead and deliver on complex projects, and interact with external partners. Responsible for global and broad organizational high impact deliverables.

Responsibilities will include:

Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects.

Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.

Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.

Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.

Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.

Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.

Who You Are:

Required:

BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.

7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)

Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).

Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.

Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.

Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.

Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.

Preferred:

Medical affairs experience (Phase IIIB - IV trials experience)

Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).

Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).

Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.

BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.

Location / Travel

This is an onsite role and must be on campus a minimum of 3 days per week.

Up to 10% travel for conferences, investigator meetings, etc.

The expected salary range for this position based on the primary location of South San Francisco, California is $140,900 - 261,700.  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

Relocation benefits are not available for this posting.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.