Director, Clinical Operations

Job Title: Director, Clinical Operations

Location: Waltham, MA  Hybrid – onsite 3 days/week required

Reports To: Vice President, Clinical Operations

Role 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 finance
• Support 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 preferred
• 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
• 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
• 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
• Strong project management experience and skills is preferred
• Demonstrate strong leadership, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environment
• Strong interpersonal, negotiation, influencing, problem-solving skills
• Excellent written and verbal skills required
• Willing to travel domestically and internationally up to 25% of the time
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Clear and concise oral and written communication skills
• Excellent organizational skills and experience prioritizing conflicting demands
• Critical thinking, problem solving, ability to work independently.
• Consistently operate with urgency, clarity and conciseness
• Communicate effectively and articulate complex ideas in an easily understandable way

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. 

Location: Waltham, MA  Hybrid – onsite 3 days/week required