Kodiak Sciences

Senior Manager / Manager, Clinical Data Management

Kodiak Sciences  •  Palo Alto, CA (Onsite)  •  6 days ago
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Job Description

Kodiak Sciences is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. This role is on-site at Kodiak's headquarters in Palo Alto, CA.  We are seeking a dedicated and detail-oriented person to support data management activities for clinical trials. This role will contribute to database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission-ready data. The ideal candidate will bring strong hands-on experience and a collaborative mindset, working closely with cross-functional teams to drive successful trial execution and regulatory submissions.  Responsibilities
  • Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
  • Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
  • Collaborate with external data management vendors to ensure timely and high-quality deliverables; track performance against project timelines and quality standards.
  • Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA).
  • Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
  • Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting.
  • Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms).
Education / Qualifications
  • Bachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.
  • 10+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
  • Experience managing study-level data management activities and working with external vendors.
  • Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).
  • Demonstrated experience supporting regulatory submissions is a plus.
  • Strong problem-solving, organizational, and communication skills.
Kodiak Sciences

About Kodiak Sciences

Kodiak is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform™ uses molecular engineering to merge the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak's discovery engine. Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases. KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy. KSI-101, our third product candidate, is a novel anti-IL-6, VEGF-trap bispecific protein for the treatment of retinal inflammatory diseases. We are advancing our platform technology to embed small molecules and other active pharmaceutical ingredients for multifactorial diseases.

WORKING AT KODIAK

We foster a culture of curiosity, creativity, compassion and courage. Our collective goal is to make a difference in the world. We do that as a team driven by the shared desire to tackle some of the world’s biggest challenges. If this sounds exciting, we want to hear from you!

Kodiak supports a vibrant and active lifestyle, striving to provide an optimal work-life balance. We are located in Palo Alto, in the heart of the world-class biotech hub of Silicon Valley, and within walking distance to California Avenue’s shops, restaurants and public transportation.

Industry
Biotech & Life Sciences
Company Size
51-200 employees
Headquarters
Palo Alto, California
Year Founded
2009
Website
kodiak.com
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