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

Job Title: Clinical Trial Manager/Senior Clinical Trial Manager         

Location: Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.  Remote may be considered.

About Us: 

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.  

Role Overview: 

Will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka's clinical pipeline.  Independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe. May serve as the clinical functional lead and lead clinical trial initiatives for Oruka's cutting-edge dermatology treatments.

Key Responsibilities: 

• Clinical Trial Management:
• 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.
• Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.
• In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.
• Team Leadership:
• Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
• Successfully interface with Data Management, Biostatistics and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines
• Foster a collaborative team environment focused on operational efficiency and continuous improvement.
• Regulatory and Compliance Oversight:
• Ensure that clinical trials are conducted in compliance with all applicable regulations, including FDA, EMA, and ICH-GCP guidelines.
• 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.
• Budget and Resource Management:
• Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.
• Monitor and control trial costs to ensure alignment with project forecasts and company objectives.
• Negotiate contracts and budgets with clinical vendors and investigators.
• Vendor and Site Management:
• Oversee the selection and management of clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.
• Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.
• Perform risk assessment and management, addressing issues proactively to mitigate operational issues. 

Qualifications:

• 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.

Job Location:

• Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.  Remote may be considered.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Manager/Sr. Manager, Clinical Outsourcing

Location: Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.

Role Overview

The Manager/Sr. Manager, Clinical Outsourcing is responsible for supporting business aspects of vendor and site agreements across defined clinical service providers and other outsourcing needs for current and future clinical trials. Responsibilities include contract negotiations, budget management, and contract quality control through the support the Clinical Operations, Biometrics and Medical Affairs departments in the oversight of service provider performance. This position reports to either the Sr. Dir, Clinical Outsourcing or to the Associate Director of Clinical Outsourcing.  This position is expected to drive effective vendor selection, contract lifecycle management in partnership with multiple functions across Oruka Therapeutics to support high quality clinical trial planning and execution.

Key Responsibilities

• Assist in the development of structure and processes supporting a newly created Clinical Outsourcing function within Clinical Operations
• Drive the creation of complex RFI and RFP document templates
• Lead and contribute to complex outsourcing initiatives and process improvement as identified
• Creates effective partnerships with vendors to cultivate and support long term relationships
• If applicable, negotiation of Clinical Trial Agreements and site budgets with US and Canadian sites
• Oversight of third party negotiations of global Clinical Trial Agreements / Site Budgets
• Participates and assists with vendor governance activities as needed
• Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance
• Manages corporate risk by working with legal to develop contracts that ensure services are completed with high quality and within budgets and timelines
• Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs
• Negotiate final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers
• Negotiates change orders and ensures vendors adhere to contract terms.
• Generates Request for Information (RFIs), Request for Proposal (RFPs), and assist Clinical Operations, Biometrics or Clinical Development with the service provider selection process including bid comparison analysis, bid defense coordination and leadership of proposal review meetings
• Oversight and execution of contract lifecycle management for assigned clinical studies, vendors and/or program(s)
• Drives the identification, development, improvement and implementation of processes and tools related to outsourcing activities
• Key contributing member of the Clinical Outsourcing team and mentors junior team members

Minimum Qualifications  

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• 6+ years of related experience in a Biotech or Pharmaceutical organization.
• Solid foundational understanding of drug development, clinical operations and clinical outsourcing
• Ability to prepare/negotiate/track external provider work/change orders, etc.
• Excellent negotiation skills
• Provide a customer service approach to internal team members
• Must demonstrate an understanding of vendor budgets and payment terms.
• Experience in RFI/RFP development, proposal evaluation, and contract and budget management.
• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet
• Must be a self-starter who works with limited supervision
• Works effectively in a matrix cross-functional environment and can effectively influence stakeholders
• Good business judgment and a strong understanding of the unique aspects of clinical financials
• Must have the ability to interact with a diverse set of clinical team and functions across Oruka Therapeutics
• Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present budget information effectively
• High sense of accountability/urgency

Preferred Qualifications   

• Preferred experience in RFI/RFP development, proposal evaluation, preparation/negotiation of clinical contractual agreements, manage contract lifecycle and budget management for assigned clinical project/operations
• Experience in working across a wide variety of functions supporting the drug development process and specialty service vendors
• Experience in trials with complex outsourcing models

 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 the Manager level is $146,000 – $161,000 and for the Senior 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.

Location:

Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.