Director, Clinical Operations

Director, Clinical OperationsWaltham, Massachusetts, United StatesAbout Us:Oruka Therapeutics 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.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 OperationsLocation: Waltham, MA Hybrid – onsite 3 days/week requiredReports To: Vice President, Clinical OperationsRole Overview: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 individual will successfully lead and optimize activity across multiple studies for Oruka Therapeutics. This critical role demands a strategic leader who possesses a keen ability to "zoom in" on intricate operational details while simultaneously "zooming out" to maintain a holistic view of program progress and timelines. 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. We are looking for a candidate that can demonstrate a high degree of integrity, pragmatism and is laser focused on commitment to study goals. You should be comfortable being a 'player/coach' taking on tactical tasks as required in support of the program.Key Responsibilities:Strategic Oversight & Agility in Clinical Study Planning, Management and Execution:Develop and implement strategic operational plans for clinical trials, ensuring alignment with program goals and business objectives.Proactively identify potential risks, bottlenecks, and deviations from timelines, and swiftly implement corrective actions with a flexible and adaptable approach.Demonstrate the ability to rapidly assess evolving circumstances (e.g., regulatory changes, unexpected site challenges, vendor issues) and adjust operational strategies accordingly.Maintain a high-level overview of all assigned clinical trials, understanding interdependencies and potential impacts on overall program timelines.Operational Excellence & Detailed Focus in Conducting Clinical Trials:Provide expert operational guidance and oversight for all phases of clinical trials, from study startup through close-out.Possess the ability to delve into granular operational details when necessary to identify root causes and inform strategic decisions.Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, Standard Operating Procedures (SOPs), and company policies.Oversee the selection, qualification, and management of Contract Research Organizations (CROs) and other third-party vendors, ensuring their performance meets expectations and timelines.Maintain oversight of clinical operations budgets, including regular forecasting and internal reporting to management and financeSupport supply chain planning and management with both clinical and non-clinical supplies for trial execution.Timeline Management & Proactive Problem Solving in Executing Clinical Trial Programs: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:We need a hands-on leader who can contribute individually to deliverables and meet deadlines to hit ORUKA milestones.Foster a culture of accountability, continuous improvement, and proactive problem-solving within the clinical operations group.Represent Clinical Operations in internal and external meetings, contributing to strategic discussions and decision-making.Qualifications:BA/BS required in a scientific/medical field preferredA minimum of 10+ years of experience in managing global clinical trials at all stages of developmentExperience in immunological and dermatologic disease areas welcomeCapable of managing direct reports from afar and study team members across multiple time zones and culturesDemonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activitiesDemonstrated successful management and oversight of CROs and other service providersDeep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetingsSignificant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activitiesStrong vendor management experience requiredExperience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.Experience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closureExperience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activitiesStrong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulationsStrong project management experience and skills is preferredDemonstrate strong leadership, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environmentStrong interpersonal, negotiation, influencing, problem-solving skillsExcellent written and verbal skills requiredWilling to travel domestically and internationally up to 25% of the timeProficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirableStrong computer and database skillsClear and concise oral and written communication skillsExcellent organizational skills and experience prioritizing conflicting demandsCritical thinking, problem solving, ability to work independently.Consistently operate with urgency, clarity and concisenessCommunicate effectively and articulate complex ideas in an easily understandable wayCompensation: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.Location: Waltham, MA Hybrid – onsite 3 days/week requiredSalary Range for the Role$213,000 - $240,000 USDWhat We Offer:A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.Competitive salary and benefits package.A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.Opportunities for professional growth and development.