Job Title: Associate Director, CMC Lead, Late-Stage Biologics      

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

Role Overview: The Associate Director of CMC Leadership will provide technical and strategic leadership for late-stage CMC activities supporting the development, characterization, validation, licensure application, commercial readiness, and lifecycle management of biologics manufacturing process, with a focus on monoclonal antibodies. This role is a critical addition to our growing organization and is highly visible within the CMC team and across other functions. Serving as a matrix leader, this role will work closely with the CMC function leads in drug substance, drug product, analytical, and clinical supply chain. This role will also partner closely with Program Management, Quality, Regulatory Affairs, CDMOs, and consultants.

The ideal candidate is an established technical and matrix leader with hands-on technical experience in biologics process development and manufacturing support, and proven track record in leading cross-functional teams to achieve complex technical and regulatory milestones and bring late-stage biologics therapeutics to commercialization.

Key Responsibilities: 

• Oversee technical operations and lead strategy discussions for late-stage CMC activities including process characterization, PPQ, licensure application, regulatory inspection, and lifecycle management of monoclonal antibody therapeutics.
• Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports, in-process-control documents, process validation master plan, and BLA Module 3 sections.
• Lead CMC meetings and ensure drug substance, drug product, analytical, clinical supply chain, quality, program management, and regulatory affairs teams are aligned with overall CMC and program strategy.
• Maintain an effective action tracker for internal and external CMC deliverables. Adapt to changing priorities to ensure corporate CMC objectives are at the forefront.
• Facilitate problem solving, action planning, and decision making within the CMC team while keeping program level stakeholders informed at regular intervals.
• Foster a strong relationship with CDMOs and consultants. Ensure the external partners are fully aligned on Oruka strategy and goals.
• Liaise with internal and external stakeholders to support timely completion of technical. documents, batch records, campaign readiness, lot release, campaign reports, change controls, deviation investigations, and CAPAs.
• Partner with CDMO counterparts to oversee all CMC service, ensuring high quality work, timely delivery, and efficient meetings.
• Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply and distribution plans.
• Drive preparation and presentation of CMC content for internal and external meetings, facilitate cross-functional offsite workshops, and help organize business review meetings with CDMOs
• Support the diligence process and contract negotiation with new CDMOs and consultants.
• Work with program managers and Finance to track budgets, contracts, and change orders.
• 20-25% travel in support of diligence process, strategy discussion meetings, and activity supervision at CDMOs.

Qualifications:

• Master’s or PhD in relevant disciplines with 10+ (MS) or 7+ (PhD) years of experience in biologics CMC functions including upstream, downstream, analytical, and drug product.
• Must have experience leading late- and commercial-stage CMC activities including process characterization, PPQ, BLA, regulatory inspections, life cycle management, and post approval submissions.
• Prior matrix leadership experience is highly preferrable. Have led cross-functional CMC teams to drive strategy alignment on risk mitigation, resource planning, process validation, regulatory filing, and post approval changes.
• Experience with pre-filled syringe and/or auto-injector is a plus.
• Strong program management skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
• In-depth knowledge of CMC quality and regulatory requirements in support of global regulatory filings
• Experience with managing CDMOs. Demonstrated track record of successful tech transfers to commercial CDMOs
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Strong sense of urgency and ability to direct the CMC team towards their deliverables in a highly fast paced environment

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, who will work in Waltham, MA -OR-remotely, is $182,000 to $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.

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: Executive Medical Director, Clinical Development         

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

Role Overview: The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.  This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.  The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.  The role reports to the Vice President of Clinical Development. 

Key Responsibilities:

• Strategic Leadership:
• Drives the clinical development strategy for one or more assets
• Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
• Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
• Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
• Clinical Trial Design and Oversight:
• Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
• Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
• Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects 
• Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment
• Stays current with relevant medical literature and clinical trial methodologies

• Contributes medical expertise to external interactions, including KOL engagement, advisory boards, and regulatory interactions as appropriate

• Cross-Functional Collaboration:
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment
• Presents clinical data to internal and external stakeholders as appropriate
• People Leadership & Team Development:
• Leads and develops a high-impact team
• Provides coaching, mentorship, and performance management
• Fosters a culture of accountability, collaboration, and scientific rigor
• Supports hiring and resource planning in partnership with leadership

Qualifications:

• Medical degree (MD) ideally with board certification in a relevant specialty
• Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership
• Proven people leadership experience, including managing and developing direct reports in small or growing teams
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience
• Excellent communication, leadership, and analytical skills
• Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution 

Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting

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 $331,000 to $368,000. 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.

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: Scientist/Senior Scientist, Upstream, Process Development & Manufacturing (Biologics)  

Location: Hybrid – Waltham, MA required to be in-office 3 days/week -OR- Remote

Position Overview: 

We are seeking an experienced and motivated Scientist/Senior Scientist to support upstream manufacturing activities. This role will be instrumental in contributing to process development and delivery of clinical trial material at CDMOs. The ideal candidate will collaborate cross-functionally within the CMC team including downstream, analytical, and drug product and other stakeholders such as QA, regulatory, and program management.  The successful candidate will help support CMC strategy in a fast-paced, innovative environment. You will be an integral part of a growing team with an opportunity to contribute towards developing best-in-class biotherapeutics.

Key Responsibilities

• Support cell culture process development and manufacturing activities at external CDMOs.
• Execute and support upstream process development, scale-up, and tech transfer to enable drug substance supply.
• Partner closely with CDMOs to execute fit‑for‑purpose upstream processes aligned with development timelines.
• Support planning and execution of drug substance manufacturing campaigns, including batch record review, sampling plans, deviations, investigations, and change management.
• Serve as person‑in‑plant (PIP) during key manufacturing campaigns to support real‑time issue resolution.
• Identify and mitigate technical and development risks using phase‑appropriate strategies.
• Manage upstream timelines and deliverables to ensure on‑time material delivery and effective cross‑functional handoffs.
• Apply phase‑appropriate QbD principles and analyze process data to support development decisions.
• Contribute to upstream sections of regulatory submissions (INDs, IMPDs).
• Travel up to 20–25% to support CDMO activities.

Qualifications

• PhD or Master’s degree in Engineering or Biological Sciences with ~3-5 years of experience in upstream process development and/or manufacturing of biologics.
• Strong hands‑on expertise in CHO cell culture process development, scale‑up, media optimization, and bioreactor operations; mAb experience preferred.
• Solid understanding of upstream process parameters, product quality attributes, and troubleshooting in clinical manufacturing.
• Experience supporting or leading upstream tech transfer to CDMOs.
• Familiarity with phase‑appropriate cGMP and development regulatory expectations.
• Demonstrated ability to analyze and interpret process and manufacturing data.
• Exposure to upstream process characterization (PC) and process performance qualification (PPQ) is a plus
• Strong written and verbal communication skills and ability to work effectively with cross‑functional and external partners.
• Self‑motivated, execution‑focused, and comfortable operating in a fast‑paced, early‑stage biotech environment.

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 $130,000 to $208,000, who will work in Waltham, MA or remote if not living within commutable distance to Waltham. 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.

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: Senior Publications Manager         

Location: Remote          

Role Overview: We are looking for a Senior Publications Manager to lead publication planning and execution across our clinical and scientific programs. This role will be responsible for driving high-quality, timely development of manuscripts, abstracts, posters, and related scientific communications in close partnership with internal cross-functional teams and external medical writing vendors.

This is a highly collaborative, hands-on role for someone who understands the strategic importance of publications in biotech and can manage multiple deliverables across a fast-moving environment. The right person will be comfortable building processes, partnering with subject matter experts, and ensuring scientific outputs are accurate, compliant, and aligned with broader medical affairs and development objectives.

This role is ideal for someone who enjoys both strategy and execution and is excited to help build the publications function within a growing biotech company.

Key Responsibilities: 

Publications Strategy and Planning

• Lead development and execution of publication plans aligned with company strategy, clinical milestones, and medical affairs objectives
• Partner with Medical Affairs, Clinical Development, Biostatistics, Regulatory, and other internal stakeholders to identify publication opportunities and priorities
• Help define publication strategy across manuscripts, abstracts, posters, congress presentations, and other scientific outputs
• Maintain visibility into timelines, dependencies, and milestone-driven deliverables across programs
• Track relevant congress deadlines and publication opportunities to support proactive planning

Publication Development and Execution

• Manage end-to-end development of scientific publications, including:
• manuscripts
• review articles
• abstracts
• posters
• oral presentations
• encore materials, as appropriate
• Coordinate author review, internal review, and approval workflows to support on-time delivery
• Ensure materials accurately reflect scientific data and are consistent with agreed messaging and publication objectives
• Partner with internal subject matter experts to shape content direction, interpret data, and resolve comments efficiently
• Support preparation for scientific congresses by driving abstract and poster development from concept through final delivery
• Oversee publication timelines, status trackers, and document version control

Vendor and Agency Management

• Serve as the primary point of contact for external medical writing vendors and publications agencies
• Manage vendor scope, timelines, budgets, and deliverable quality
• Provide clear direction and feedback to vendors to ensure content meets scientific, stylistic, and strategic expectations
• Review drafts critically for scientific accuracy, clarity, completeness, and consistency
• Help establish productive, scalable ways of working with external writing partners
• Monitor vendor performance and help identify opportunities to improve efficiency, quality, and collaboration

Process and Compliance

• Help build and refine publications processes
• Ensure publication activities are conducted in accordance with internal policies, publication standards, and applicable industry guidelines
• Support documentation of publication decisions, authorship rationale, and review history as needed
• Contribute to publication governance, tracking, and planning tools that improve transparency and execution
• Promote high standards for scientific integrity, authorship practices, and publication quality

Qualifications:

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• Advanced degree in life sciences preferred

• Experience in the dermatology or immunology therapeutic areas highly preferred.
• 5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment
• Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes.
• Strong experience managing scientific publications, including manuscripts, abstracts, and posters
• Demonstrated experience working with and managing external medical writing vendors or publications agencies
• Strong understanding of publication planning, congress execution, and scientific data communication
• Excellent project management skills with the ability to manage multiple complex deliverables simultaneously
• Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback
• High attention to detail and commitment to scientific accuracy, quality, and compliance
• Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment
• Ability to operate with autonomy and help build processes where structure is still evolving
• The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value

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, who will work remotely is $161,000 to $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.

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: Senior Manager, Clinical Supply Chain (Biologics)         

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.          

Role Overview: We are seeking an experienced and motivated candidate to execute clinical supply chain activities in support of early-to-late-stage clinical trials. In this role, you will be responsible for overseeing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies. You are an ideal candidate for this role if you enjoy working in a fast-paced, high-touch environment establishing strong relationships across CMC, Clinical, Program Management, Regulatory and Quality. You will be reporting to and working alongside the head of Clinical Supply Chain to help establish Clinical Supplies processes and best practices, while supporting multiple clinical trials across US, Canada and EU. You are highly communicative and motivated to produce results effectively, efficiently and early to support global clinical supply chain activities in support of vials and pre-filled syringes.

Key Responsibilities: 

• Execute clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Author, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocols
• Serve as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPs
• Support site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction information
• Plan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory management
• Support clinical supply and logistics planning in support of global regulatory filings
• Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs
• Support clinical distribution across US, Canada and EU through both IRT and manual driven site shipments and depot transfers
• Verify with Quality the accuracy within blinded studies’ drug release, shipments & IRT setup
• Identify and execute process improvements through report development and SOPs
• Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOs
• Serve as person-in-plant (PIP) during label and packaging campaigns
• 20-25% travel in support of diligence and campaign execution at the CPOs

Qualifications:

• Bachelor’s or Master’s in a scientific discipline with 6+ years of relevant experience in clinical supply chain and logistics
• Must have hands-on experience managing supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Experience with clinical supply chain involving cold chain products is a plus
• Exposure to support clinical supply activities involving vials or pre-filled syringes is a plus
• Demonstrated experience managing import/export for clinical studies in US, Canada and EU
• Strong clinical supply skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
• In-depth knowledge of quality and regulatory aspects of clinical supply chain in support of simple to complicated multi country clinical studies
• Demonstrated track record of successful tech transfers to commercial CPOs with an eye towards late stage and commercial launch
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Must have a creative, organized and strategic attitude with the ability to work in a fast-paced environment

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, who will work in Waltham, MA, is $161,0000 to $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.

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: 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: Administrative Assistant

Location: Waltham, MA / Onsite presence 2-3 days per week required

Role Overview: The Administrative Assistant will provide support to multiple team members across our medical and clinical operations groups. This role is well- suited for someone who thrives in a fast-paced, collaborative environment and enjoys balancing administrative and operational responsibilities. The ideal candidate is resourceful, able to anticipate needs, and comfortable adapting quickly as priorities shift.

Key Responsibilities:

• Proactively manage complex, multi-time-zone calendars and provide day-to-day administrative support to multiple team members
• Coordinate domestic and international travel arrangements, including flights and accommodations
• Prepare and submit accurate, timely expense reports in accordance with company policies
• Assist with internal and external meeting logistics including greeting guests, catering, and materials as needed
• Proactively manage kitchen inventory by stocking supplies and ensuring a clean, organized space
• Serve as the primary point of contact for vendors delivering office supplies and services, and monitor inventory levels, placing orders as needed to maintain appropriate stock.
• Assist the Senior Executive Assistant with planning and executing internal events, offsites, and company gatherings

Education and Qualifications:

• Bachelor’s degree or equivalent and 3+ years of administrative experience, preferably in biotech, healthcare, or a fast-paced environment
• Strong organizational skills with excellent attention to detail
• Ability to manage multiple priorities and adapt to changing needs
• Proficiency with calendar management, expense reporting tools, and standard office software (e.g., Microsoft Office Suite, Google Workspace)
• Strong communication and interpersonal skills
• Ability to maintain confidentiality and professionalism
• Team player with a willingness to pitch in wherever needed

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, who will work in Waltham, MA is $28.00/hour to $35.00/hour. 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.
• Position is hybrid, based in Waltham, MA. Candidates will be required to be in-office 3 days/week.

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: Medical/Senior Medical Director, Clinical Development (Multiple openings)        

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

Role Overview: 

The Medical/Senior Medical Director of Clinical Development plays a key role in the execution and operational oversight of clinical trials, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves supporting clinical study design, implementation, and data interpretation while working cross-functionally to align clinical activities with overall development plans. The Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives.

Key Responsibilities:

• Clinical Trial Design and Oversight:
  • Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
  • Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines
  • Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug
  • Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
  • Provides medical expertise of the therapeutic area, disease state, and potential drug effects 
  • Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team 
  • Stays current with relevant medical literature and clinical trial methodologies
  • Contributes medical expertise to external interactions with collaborators throughout the clinical development cycle  
• Cross-Functional Collaboration:
  • Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process 
  • Presents clinical data to internal and external stakeholders
• Strategic Leadership:
• Contributes to the overall clinical development strategy
• Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding timelines
  • Leads the clinical contribution for clinical study reports, clinical documents and regulatory submissions
  • May oversee the work of Clinical Scientists working on the same or other programs

Qualifications:

• Medical degree (MD) with board certification in a relevant specialty
• Extensive experience in clinical research and development, ideally within the pharmaceutical industry
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements
• Excellent communication, leadership, and analytical 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 the Medical Director is $255,00-288,000 and for the Senior Medical Director $306,000 to $343,000. 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.

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: 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: Associate Director/Director, Analytical Development and Validation, Tech Ops (Biologics)         

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered.        

Role Overview:

The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities supporting the development, validation, and lifecycle management of biologic drug products, with a focus on monoclonal antibodies. This role will lead method validation and comparability efforts in support of BLA/MAA submissions, process changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.

The ideal candidate is a hands-on leader with deep expertise in analytical method validation, device functional testing, regulatory expectations for late-stage biologics, and the ability to guide teams through complex technical and compliance-driven milestones. This role is highly visible within the CMC team and a pivotal addition to our growing organization where you will play an integral role in supporting multiple programs’ analytical activities in support of releasing supplies for clinical trials and preparing for commercialization across US, Canada and EU.

Key Responsibilities: 

• Lead late-stage analytical development activities for biologics, including method validation, method qualification, and method transfer for release, stability, characterization and device functional testing assays.
• Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods.
• Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing.
• Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s).
• Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies.
• Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
• Support analytical risk assessments, control strategy development, and lifecycle management
• Serve as analytical lead for regulatory interactions, including agency questions and inspections.
• Build, mentor, and lead a high-performing analytical development team (internal and/or external)
• Set technical direction, priorities, and timelines for late-stage analytical
• Manage and provide technical oversight to CDMOs and contract
• Review and approve protocols, validation reports, development reports, and regulatory
• 20-25% travel is required for this role.

Qualifications: 

• Experience with monoclonal antibodies and PFS/Auto Injectors is a
• Associate Director: Master’s (7+ years) or PhD (5+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Director: Master’s (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.
• Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), device functional testing per ISO
• Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU.
• Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
• Experience with late-phase comparability studies, especially geared toward
• Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies
• Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Must have a creative and strategic attitude with the ability to work in a fast-paced

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, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. 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.

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: Associate Director / Director, Device Development (Prefilled Syringes & Auto-Injectors)

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered. 

Position Summary

We are seeking an experienced and driven Associate Director or Director of Device Development to lead the end-to-end development of drug delivery systems, with a focus on prefilled syringes and auto-injectors for late-stage programs and commercialization.

This role will be responsible for integrating medical device engineering, human-centered design, and human factors engineering into combination product development, ensuring safe, effective, and patient-friendly delivery solutions. The ideal candidate brings deep expertise in biomedical engineering, device development, and regulatory requirements for combination products, along with a track record of advancing programs from clinical stages through commercial launch.

Key Responsibilities

Device & Combination Product Development

• Lead development of prefilled syringes, auto-injectors, and related delivery systems from late-stage clinical development through commercialization
• Define and execute device development strategies, including design, verification, validation, and lifecycle management
• Oversee combination product integration, ensuring alignment with CMC, clinical, and regulatory strategies

Human-Centered Design & Human Factors Engineering

• Drive human-centered product development, incorporating patient, caregiver, and healthcare provider needs
• Lead human factors engineering (HFE) activities, including use-related risk analysis, formative and summative (validation) studies
• Ensure compliance with FDA, EMA, and global HFE/usability requirements

Technical Leadership

• Provide subject matter expertise in biomedical engineering and device technologies
• Lead cross-functional teams across development, clinical, regulatory, quality, and manufacturing
• Independently manage external partners, including device manufacturers, design firms, and testing laboratories

MSAT & Manufacturing Support

• Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages
• Serve as Person-in-Plant (PIP) during manufacturing campaigns, ensuring on-site technical oversight and rapid issue resolution
• Lead and support manufacturing campaigns, including engineering runs, clinical, PPQ, and commercial production
• Partner with CMOs and internal teams to ensure robust manufacturing processes, tech transfer, and scale-up
• Drive investigations, deviations, CAPAs, and continuous process improvements related to device and combination product manufacturing

Regulatory & Quality

• Support regulatory submissions (e.g., IND, BLA) with device-related content
• Ensure compliance with combination product regulations (21 CFR Part 4, ISO 13485, IEC 62366, ISO 14971)
• Partner with Quality to ensure design controls and risk management processes are implemented effectively

Qualifications

Education

• PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field

Experience

• Associate Director: 8+ years of relevant experience
• Director: 12+ years of relevant experience
• Significant experience in combination products and drug delivery devices, particularly prefilled syringes and/or auto-injectors
• Proven track record supporting late-stage development and commercialization

Technical Expertise

• Strong knowledge of:
• Medical device design and development processes
• Human factors engineering / usability engineering
• Risk management
• Design controls and validation requirements
• MSAT and manufacturing support for combination products
• Experience with biologics delivery systems preferred

Leadership & Collaboration

• Demonstrated ability to lead cross-functional, matrixed teams
• Strong communication skills with experience influencing senior leadership and external partners
• Strategic mindset with the ability to balance technical depth and business objectives

Preferred Qualifications

• Experience with regulatory interactions (FDA, EMA) for combination products
• Background in patient-centric design
• Experience with commercial device manufacturing and supply chain management

Additional Requirements

• Ability to travel up to 20%, including visits to manufacturing sites, external partners, and testing facilities

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, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. 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.

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: Director / Senior Director, Regulatory CMC (Biologics)       

Location: Hybrid – Waltham, MA Candidates will be required to be in-office 3 days/week.          

Role Overview:

We are seeking an experienced and motivated regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs. In this role, you will own the development of high-quality regulatory CMC submissions and guide cross-functional teams on phase-appropriate global regulatory expectations. You are an ideal candidate if you bring deep expertise in biologics development and manufacturing, including strong experience with drug substance and drug product CMC submissions. You will have the opportunity to influence program strategy, foster collaboration across CMC, QA, RA, Supply Chain, and external partners, and drive key decisions that support multiple programs in our rapidly growing biologics pipeline. This is a highly visible role where you will be responsible for submissions that are aligned with FDA, EMA, ICH, and WHO guidelines while supporting corporate and program level objectives.

Key Responsibilities: 

• Own and drive global regulatory CMC strategy for drug substance and drug product across all stages (IND through BLA)
• Lead development of high-quality CMC dossiers, timelines, and submission strategies for global filings
• Serve as the CMC regulatory SME on program teams, influencing cross-functional decisions and overall development strategy
• Collaborate with CMC, Supply chain, QA and RA functions to support maintenance of product compliance, shelf life, and change control procedures
• Lead cross-functional coordination to plan and deliver timely, high-quality responses to CMC regulatory information requests
• Ensure all submissions meet phase-appropriate expectations and align with FDA, HC, EMA, ICH, and WHO guidelines
• Anticipate regulatory risks and proactively develop mitigation strategies to keep programs on track
• Collaborate effectively with internal teams and external partners including CDMOs to generate high quality source documents
• Guide late-stage development planning, including process characterization, PPQ, and readiness for commercial filings
• Bring a clear, proactive, solution-oriented mindset with the attitude to manage competing priorities
• Thrive in a fast-paced biotech environment where agility and accountability matter
• Contribute to a culture of collaboration, transparency, and continuous improvement

Qualifications:

• MS or PhD in life sciences with 10+ years of experience in a biologics focused CMC role and a minimum of 5+ years of direct regulatory CMC experience
• Strong command of cGMPs, biologics development (manufacturing, release, stability) and associated global regulatory expectations. Experience with drug device combinations (e.g., prefilled syringes, auto injectors) is preferred
• Proven track record of leading global CMC submissions and preparing briefings for milestone interactions with global health authorities (FDA, EMA etc.)
• Broad experience across development stages from early development through late stage and commercialization; Hands-on experience with BLA CMC submission is ideal
• Working knowledge of drug substance and drug product CMC development, including process, analytical development, QC, and shelf-life strategy
• Demonstrated ability to operate strategically while staying close to overall regulatory planning and execution
• Experience building alignment across teams (CMC, QA, Supply chain, QA, RA and PM) in a fast-paced biotech environment
• Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines

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, who will work in Waltham, MA, is $213,000-240,000 for Director and $255,00-286,000 for Senior Director. 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.

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: Director, Clinical Quality Assurance

Location: Remote; Waltham, MA area candidates preferred. 

Role Overview:

The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.

 Key Responsibilities:

• Clinical Quality Oversight: Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures. Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle. Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation. Support development and implementation of phase-appropriate clinical quality procedures and processes.
• Quality Systems Support for Clinical Development: Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development. Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues. Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement. Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.
• Vendor and CRO Quality Oversight: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Audit Program Execution: Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs. Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed. Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness. Travel to clinical sites, vendors, and investigator meetings as needed.
• Inspection Readiness and Health Authority Support: Lead GCP inspection readiness activities across the organization, including development of inspection readiness plans, mock inspections, storyboards, SME preparation, document review, and inspection response coordination. Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities. Partner with internal teams and external vendors to ensure inspection-facing documentation, processes, and responsibilities are inspection-ready at all times.
• Risk-Based Quality Management: Embed risk-based quality management principles into study oversight and clinical quality processes. Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals. Ensure quality oversight activities are focused on matters most relevant to subject safety, rights, data integrity, and trial reliability.
• Inspection-Ready Documentation and TMF Support: Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records. Collaborate with study teams and vendors to ensure that documentation standards, reconciliation processes, and issue escalation practices support an inspection-ready state throughout study conduct.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline; advanced degree preferred.
• 10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.
• Strong knowledge of GCP and applicable global clinical regulatory requirements.
• Experience supporting quality oversight for Phase 1–3 clinical trials.
• Demonstrated experience with GCP audits, including investigator site and/or vendor audits.
• Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.
• Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.
• Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.
• Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.
• Willingness to travel as needed for audits, site visits, and inspection readiness activities (10-15%).

Preferred Qualifications:

• Experience as an early Clinical QA hire in a growing biotech company.
• Experience supporting biologics development programs.
• Familiarity with eQMS tools and clinical systems relevant to quality oversight.
• Experience with risk-based quality management and quality metrics.

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. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

 Job Location:

• Remote; Waltham, MA candidates preferred

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.

Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)        

Location: Hybrid – Waltham, MA required to be in-office 3 days/week. 

Position Overview: 

We are seeking an experienced and motivated MSAT (Manufacturing Science and Technology) leader to lead downstream late-stage and pivotal enabling optimization, scale-up and transfer of manufacturing activities. In this role, the ideal candidate will be responsible for process development, troubleshooting production issues, data analysis, and ensuring compliance with regulatory standards to maintain product quality. The successful candidate will be involved in late-stage drug substance manufacturing and process validation activities in support of BLA filing. This role involves working in a fast-paced environment and drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics.  

Key Responsibilities:

• Oversee the transfer of manufacturing processes from late-stage development to large-scale production at the CDMOs for multiple programs.
• Work with CDMOs to identify gaps and implement improvements towards enhancing product quality, robustness, and cost-effectiveness with line of sight to commercial manufacturing.
• Build strong relationships and partner cross functionally with process development, analytical, formulation, quality, regulatory and program management.
• Oversee GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
• Partner with late-stage process characterization and MSAT teams and develop robust control strategy enabling successful PPQ DS campaigns
• Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.
• Partner with stakeholders to support timely approval and execution of reports, batch records, in-process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Support regulatory filings by authoring high quality reports enabling timely submissions for multiple jurisdictions (INDs, CTAs).
• Perform MFG/MSAT risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements.
• 20-25% travel in support of manufacturing activities at CDMOs.

Qualifications:

• Master’s or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with at least 8 years of relevant experience developing, scaleup, and transfer of downstream processes for biologics.
• Significant experience managing manufacturing in an MSAT environment. Direct hands-on experience with monoclonal antibodies is a plus.
• Expertise in purification process optimization with an emphasis on scale-up, scale-down models, process robustness, facility fit and overall commercial readiness.
• In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management.
• Must have a solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns.
• Demonstrated track record of successful tech transfers to CDMOs with an eye towards late stage and commercial process development.
• Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns, with emphasis on phase appropriate control strategy.
• Direct experience in design-of-experiments (DoE) and robust data analysis via industry standard statistical tools.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Self-starter with a strategic mindset and ability to thrive in a fast-paced, collaborative environment.      

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, who will work in Waltham, MA, is $175,000 to $200,000. 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.

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.