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Senior Director, Clinical Operations

BigHat Biosciences

San Mateo, CAFull-time$275–295K/yrPosted 1mo agoVerified open 5 days ago

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At a glance

Compensation
$275–295K/yr
Location
San Mateo, CA
Schedule
Full-time
Work Authorization
Not specified

Job overview

BigHat Biosciences is hiring a Senior Director, Clinical Operations. The Senior Director, Clinical Operations will lead the design, execution, and management of early‑stage oncology and inflammatory disease biologic trials, aligning strategies with corporate goals and regulatory standards while building a high‑performing operations team in a fast‑paced startup environment.

Key focus areas include Develop and execute clinical operational strategies to advance biologics from early‑phase trials to regulatory approval, Collaborate with cross‑functional teams to align clinical strategies with company goals, and Provide insights into trial design, site selection, and patient recruitment strategies.

Successful candidates bring Experienced Clinical Operations Lead and Early-Stage Clinical Development Of Biologic Drugs. Important skills include Oncology, Inflammatory Diseases, ICH-GCP Guidelines, FDA Regulations, EMA Regulations, and Global Clinical Trial Processes. Preferred (not required): Molecularly Targeted Therapies.

Skills & qualifications

RequiredNice to have

Skills

OncologyInflammatory DiseasesICH-GCP GuidelinesFDA RegulationsEMA RegulationsGlobal Clinical Trial ProcessesVendor ManagementCRO OversightBudget ManagementTrial Risk ManagementClinical Site-Side Sample ManagementBiomarker Program SupportData Management PrinciplesData Quality OversightClinical Document GenerationCommunicationLeadershipProblem-SolvingMolecularly Targeted TherapiesClinical Operations LeadershipClinical Trial DesignClinical Trial ExecutionClinical Trial ManagementRegulatory RequirementsStrategy DevelopmentBest Practices for Trial ExecutionCollaboration

Qualifications

Advanced Degree in Life Sciences, Pharmacy, or Related Field10+ Years Clinical Operations ExperienceExperience Leading Early-Phase Clinical TrialsExperience Building and Leading TeamsPhD, MD, PharmD

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
401(k) Match
Parental Leave

Full job description

The role: We are seeking an experienced and motivated Clinical Operations Lead to join our drug development team, focusing on early-stage clinical development of biologic drugs in oncology and inflammatory diseases. As the Director and Lead of Clinical Operations, you will oversee the design, execution, and management of clinical trials, ensuring alignment with corporate objectives and regulatory requirements. You will lead a high-performing clinical operations function, develop strategies to accelerate development timelines, and establish best practices for trial execution. This is a unique opportunity to contribute at both strategic and operational levels in a fast-paced, collaborative startup environment.

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