Oruka Therapeutics

Oruka Therapeutics

Clinical Trial Manager/Senior Clinical Trial Manager

Waltham, Massachusetts, United States · Senior

Sponsorship not specified$146k-$161kDetected 51 days ago
GCPClinical TrialsFDA RegulatoryLeadershipBiostatisticsRegulatory Affairs

About the role

  • Will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka's clinical pipeline.

Responsibilities

  • Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
  • Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence.
  • In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.
  • Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
  • Support the preparation and submission of clinical trial applications, including INDs, NDAs, and other regulatory documents with functional leads.
  • Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.

Requirements

  • Bachelor's or Master's degree in life sciences or a related field.
  • 5-7+ years of experience in clinical operations, with a focus on managing complex clinical trials.
  • Expertise in GCP and regulatory requirements.
  • Strong leadership and team management skills.

Compensation

  • An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
  • The anticipated salary range for Manager level is $146,000 - $161,000 and Sr.
  • Manager level is $161,000 - $187,000.
  • The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.
  • Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
  • Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required. Remote may be considered.

Benefits

  • Competitive salary and benefits package.

Company info

  • Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
  • As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
  • Job Title: Clinical Trial Manager/Senior Clinical Trial Manager
  • Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases.
  • Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year.
  • Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.
  • For more information, visit www.orukatx.com
  • As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.
  • Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
  • Remote may be considered.
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
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This listing is sourced directly from Oruka Therapeutics's careers page and normalized into a canonical job model.