Associate Director, Clinical Operations

Job Title: Associate Director, Clinical Operations

Location: Waltham, MA.  Hybrid 3 days/week onsite.

Role Overview:

We are seeking an exceptionally nimble and flexible Associate 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 and will support the Director of Clinical Operations in a specific therapeutic indication. 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.

Our environment is dynamic, and each day presents new challenges and opportunities for growth.  This is a “hands-on” role, and the successful candidate will be able to work alongside team members, regardless of levels, to drive results.

Key Responsibilities:

Drive Study Execution

• Help plan and run clinical trials from startup through close-out
• Stay close to study timelines, milestones, and deliverables to keep things on track
• Identify risks early and work with the team to address them before they become bigger issues
• Step in where needed—whether that’s reviewing documents, following up with vendors, or troubleshooting site challenges

Work Closely with CROs and Vendors

• Partner with CROs and vendors on day-to-day execution
• Track performance and timelines, and follow up when things are off track
• Contribute to vendor selection and help ensure we’re getting what we need from external partners

Stay Close to the Details

• Review key study documents and plans with an operational lens
• Make sure studies are being run in line with GCP, SOPs, and regulatory expectations
• Support inspection readiness—keeping documentation organized and audit-ready

Help Keep the Program Moving

• Track study budgets and timelines at a working level
• Flag issues early and escalate when needed
• Help coordinate across functions (clinical, regulatory, data, etc.) so teams stay aligned

Be a Strong Team Contributor

• Work as part of a small, collaborative team where everyone contributes
• Take ownership of your areas and follow through on commitments
• Bring a practical, solutions-oriented mindset to challenges
• Willing to mentor within the Clinical Operations organization

This position will require travel up to 35% (Domestically and internationally)

Qualifications:

• BA/BS required in a scientific/medical field preferred
• A minimum of 8-10+ 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-minimum of 1-2 years of line management experience
• 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.
• Minimum of 5 years of project management experience.
• 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, decision making ability, 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
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable-Smartsheet experience a plus
• 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 is $182,000 - $208,000. 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.

Job Location:                                        

• Waltham, MA. Hybrid 3 days/week onsite