Oruka Therapeutics
Director, Clinical Operations
Waltham, Massachusetts, United States · Director
Sponsorship not specified$213k-$240kDetected 49 days ago
GCPProject ManagementNegotiationForecastingExcelSupply ChainVendor ManagementClinical TrialsResearchLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingAdaptabilityOrganizational SkillsMicrosoft OfficeGxP
About the role
- We are seeking an exceptionally nimble and flexible Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources.
- The successful candidate will be a proactive problem-solver, adept at navigating complexities, anticipating challenges, and implementing agile solutions to ensure our clinical trials remain on schedule and within budget.
Responsibilities
- Develop and implement strategic operational plans for clinical trials, ensuring alignment with program goals and business objectives.
- Maintain a high-level overview of all assigned clinical trials, understanding interdependencies and potential impacts on overall program timelines.
- Maintain oversight of clinical operations budgets, including regular forecasting and internal reporting to management and finance
- Support supply chain planning and management with both clinical and non-clinical supplies for trial execution.
- Lead and manage clinical trial timelines, ensuring key milestones are met and proactively mitigating any delays.
- Implement robust tracking and reporting mechanisms to monitor trial progress and identify potential deviations early.
- Develop and execute contingency plans to address unforeseen challenges and keep trials on track.
- Facilitate effective communication and collaboration across cross-functional teams to drive trial progression.
- Operate as a "Hands-On" Leader & Develop Teams in a Fast-Paced Environment:
Requirements
- A minimum of 10+ years of experience in managing global clinical trials at all stages of development
- Experience in immunological and dermatologic disease areas welcome
- Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities
- Strong vendor management experience required
- Experience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.
- Experience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure
- Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities
- Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
- BA/BS required in a scientific/medical field preferred
- Capable of managing direct reports from afar and study team members across multiple time zones and cultures
- Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
- Demonstrated successful management and oversight of CROs and other service providers
- Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings
Nice to have
- Strong project management experience and skills is preferred
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 candidates is $213,000 - $240,000.
- 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.
- Salary Range for the Role
- $213,000 - $240,000 USD
Benefits
- Competitive salary and benefits package.
- Proactively identify potential risks, bottlenecks, and deviations from timelines, and swiftly implement corrective actions with a flexible and adaptable approach.
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: Director, Clinical Operations
- 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.
- Reports To: Vice President, Clinical Operations
- 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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