Senior Principal, Clinical Data Lead

Company Description

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission: Caring Deeply, Achieving Excellence, Changing Lives.

Our team in San Francisco is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

Job Description

The Sr Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They will provide operational leadership and be accountable for of all Clinical Data Management activities throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR).

What you’ll do

• Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress.
• Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
• Develops risk mitigation or action plans and oversees execution when appropriate.
• Reviews operational performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution.
• Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed.
• Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and develops/implements risk mitigation strategies for all issues.
• Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.

Who You Are

You are recognized as an operational specialist in clinical data flow and study execution by all cross-functional groups. You enjoy leading project teams, thrive on project deadlines, and are passionate about the clinical trial arena.  

Qualifications

Required Skills

• Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 7+ years relevant work experience with a focus on clinical data management, 4+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock
• Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as J-Review or Business Objects required
• Deep understanding of drug development and biopharmaceutical industry required
• Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
• High attention to detail including proven ability to manage multiple, competing priorities
• Experience overseeing outsourced clinical trials work

Additional Information

The base compensation range for this role is $122,000 - $196,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and