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Senior Clinical Trial Manager

Oruka TherapeuticsWaltham, Massachusetts, United States
Hybrid Full-time $155K/yr - $180K/yr

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Experience Level

Senior

Qualifications

Qualifications:Proven experience in clinical trial management, preferably in the biotechnology or pharmaceutical industry. Strong knowledge of regulatory requirements and clinical trial methodologies. Excellent organizational and leadership skills with a focus on results. Ability to manage multiple projects simultaneously while maintaining attention to detail. Effective communication skills, both written and verbal, to collaborate with diverse teams.

About the job

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologics aimed at redefining the treatment landscape for chronic skin conditions. Our mission is to provide individuals afflicted by chronic skin diseases, such as plaque psoriasis, with unparalleled freedom from their ailments through therapies that may require administration only once or twice annually. We are advancing a unique portfolio of potentially leading antibodies, engineered by Paragon Therapeutics, that target the fundamental mechanisms of plaque psoriasis and other dermatologic and inflammatory conditions. To learn more, please visit www.orukatx.com.

As we expand our core team, we are on the lookout for exceptional talent across various functional areas. We seek individuals who are not only searching for employment but also aspire to be part of a transformative mission. If you are passionate about making a meaningful impact and are eager to help cultivate a vibrant, inclusive, and positive organizational culture, we encourage you to apply.

Job Title: Senior Clinical Trial Manager

Location: Hybrid – Waltham, MA. Candidates are expected to work in the office 3 days per week.

Role Overview:

The Senior Clinical Trial Manager will act as the clinical functional lead, spearheading clinical trial initiatives for Oruka's innovative dermatological treatments. You will be responsible for ensuring compliance with trial protocols, regulatory standards, and operational efficiency while collaborating with cross-functional teams to propel Oruka's clinical pipeline forward. A Senior Clinical Trial Manager is expected to manage the clinical trial independently, effectively planning and executing the study to guarantee the quality of deliverables within the specified budget and timeline.

Key Responsibilities:

  • Clinical Trial Management:
    • Lead and oversee multiple clinical trials from initiation through completion, ensuring compliance with study timelines and financial parameters.
    • Collaborate with investigators, vendors, and cross-functional teams to assure excellent study execution and operational performance.
    • Supervise the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.

About Oruka Therapeutics

Oruka Therapeutics is at the forefront of developing groundbreaking biologics that aim to revolutionize treatment protocols for chronic skin diseases. Committed to improving the lives of patients, Oruka strives for high rates of disease clearance with innovative therapies that minimize treatment frequency.

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