Job Title: Medical Science Liaison-Southeast

Location: Field-based, covering VA, WV, NC, SC, GA, FL, TN. The candidate is required to live in the territory.

Role Overview:

Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.  The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites. 

Summary:

MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy. 

Key Responsibilities: 

• Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange
• Stay informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences
• Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs
• Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs
• Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs 

Qualifications:

• Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required
• Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred
• Prior experience as a field medical science liaison required, experience in Dermatology preferred
• Routine and tangible experience in a field medical role working with CRO and clinical operations preferred
• Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry
• Self-driven and ability to work independently with minimal direct supervision
• Exceptional communication and time management skills
• Applicants must live within applicable territory with convenient access to national/international airport.

Travel Requirements:

• Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)

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 $182,00 to $235,00. 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: Medical Science Liaison-South Central

Location: Field-based, covering MS, LA, AR, OK, TX, AL, KS. The candidate is required to live in the territory.

Role Overview:

Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.  The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites.

Summary:

MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy. 

Key Responsibilities: 

• Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange
• Stay informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences
• Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs
• Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs
• Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs 

Qualifications:

• Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required
• Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred
• Prior experience as a field medical science liaison required, experience in Dermatology preferred
• Routine and tangible experience in a field medical role working with CRO and clinical operations preferred
• Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry
• Self-driven and ability to work independently with minimal direct supervision
• Exceptional communication and time management skills
• Applicants must live within applicable territory with convenient access to national/international airport.

Travel Requirements:

• Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)

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 $182,00 to $235,00. 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: Medical Science Liaison-Northwest

Location: Field-based, covering CO, WY, UT, MT, ID, OR, WA, IA, ND, SD. The candidate is required to live in the territory.

Role Overview:

Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.  The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites. 

Summary:

MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy. 

Key Responsibilities: 

• Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange
• Stay informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences
• Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs
• Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs
• Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs 

Qualifications:

• Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required
• Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred
• Prior experience as a field medical science liaison required, experience in Dermatology preferred
• Routine and tangible experience in a field medical role working with CRO and clinical operations preferred
• Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry
• Self-driven and ability to work independently with minimal direct supervision
• Exceptional communication and time management skills
• Applicants must live within applicable territory with convenient access to national/international airport.

Travel Requirements:

• Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)

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 $182,00 to $235,00. 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: Medical Science Liaison-North Central

Location: Field-based, covering IL, IN, MI, WI, MO, OH, Western PA/Pittsburgh . The candidate is required to live in the territory.

Role Overview:

Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.  The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites. 

Summary:

MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy. 

Key Responsibilities: 

• Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange
• Stay informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences
• Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs
• Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs
• Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs 

Qualifications:

• Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required
• Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred
• Prior experience as a field medical science liaison required, experience in Dermatology preferred
• Routine and tangible experience in a field medical role working with CRO and clinical operations preferred
• Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry
• Self-driven and ability to work independently with minimal direct supervision
• Exceptional communication and time management skills
• Applicants must live within applicable territory with convenient access to national/international airport.

Travel Requirements:

• Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)

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 $182,00 to $235,00. 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: Medical Science Liaison-Northeast 

Location: Field-based, covering MA, ME, NH, VT, CT, RI, NY, NJ, MD/DC, Eastern PA. The candidate is required to live in the territory.

Role Overview:

Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.  The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites.

Summary:

MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy. 

Key Responsibilities: 

• Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange
• Stay informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences
• Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs
• Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs
• Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs 

Qualifications:

• Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required
• Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred
• Prior experience as a field medical science liaison required, experience in Dermatology preferred
• Routine and tangible experience in a field medical role working with CRO and clinical operations preferred
• Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry
• Self-driven and ability to work independently with minimal direct supervision
• Exceptional communication and time management skills
• Applicants must live within applicable territory with convenient access to national/international airport.

Travel Requirements:

• Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)

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 $182,00 to $235,00. 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: Senior Scientific Communications Manager        

Location: Remote          

Role Overview: We’re looking for a Senior Scientific Communications Manager to join our growing biotech team. This is a hands-on role for someone who enjoys turning complex scientific and clinical information into clear, accurate, and useful communications for a variety of audiences.

At a small startup, this person will wear multiple hats. You’ll help shape our scientific story externally and internally, while also building and supporting core Medical Information capabilities. That means creating high-quality scientific materials and helping ensure that medical inquiries are addressed in a timely, accurate, balanced, and compliant way.

This role is a great fit for someone who is scientifically strong, highly organized, comfortable with ambiguity, and excited to build processes in a fast-moving environment.

Key Responsibilities: 

Scientific Communications

• Develop and refine clear, compelling scientific messaging across programs and stages of development
• Draft and manage scientific content such as:
• slide decks
• congress materials
• medical Information letters
• medical affairs and training materials
• FAQs and background documents
• external sci comm projects (e.g. webinars, podcast, product theaters, symposia)
• Translate preclinical, translational, and clinical data into audience-appropriate communications
• Partner cross-functionally with Medical Affairs, Clinical Development, Regulatory, and company leadership to ensure scientific accuracy and message consistency
• Help prepare materials for advisory boards, investigator meetings, and scientific congresses
• Contribute to the development of the company’s scientific narrative as programs advance

Medical Information

• Help build and maintain core Medical Information content and processes in an early-stage company environment
• Develop, review, and update standard medical response documents and reference materials
• Research and synthesize literature and internal data to support responses to unsolicited medical inquiries
• Ensure responses are accurate, balanced, evidence-based, and compliant with internal and external requirements
• Partner with Medical Affairs, Regulatory, and Pharmacovigilance to support appropriate documentation and escalation of medical inquiries, adverse events, and product complaints, as applicable
• Maintain a library of response letters, FAQs, and scientific references
• Identify trends in incoming medical questions and share insights with internal stakeholders
• Support training of internal teams on scientific messaging and Medical Information processes
• Help manage external Medical Information vendors or agency partners, when applicable

Other Requirements: the ability to travel at least twice yearly to company all hands meetings and optionally to scientific conferences where you feel your presence is of value

Qualifications: 

• Advanced degree in life sciences preferred
• Approximately 5+ years of relevant experience in scientific communications, medical communications, medical affairs, medical information, or a related biotech/pharma function
• Experience in dermatology or immunology strongly preferred
• Strong scientific writing and editing skills, with the ability to tailor content to different audiences
• Solid understanding of drug development, clinical research, and interpretation of scientific data
• Experience supporting scientific communications deliverables such as presentations and congress materials
• Experience developing or reviewing Medical Information content is strongly preferred
• Strong attention to detail and commitment to scientific accuracy and compliance
• Able to work independently, manage multiple priorities, and adapt quickly in a startup setting
• Experience working with vendors, medical writers, or outsourced contact center/Med Info partners
• Collaborative, practical, and comfortable working across functions with limited structure

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: Clinical Scientist, Clinical Development (Multiple openings)       

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

Role Overview: 

The Clinical Scientist plays a key role in the execution and operational support of clinical trials, assisting in the collection and review of clinical data to ensure study success. This role involves supporting protocol development, study implementation, data review, and documentation preparation to align with clinical development goals. The Clinical Scientist collaborates closely with cross-functional teams to ensure the generation of high-quality clinical data. Additionally, they work closely with the Medical Director, Clinical Development to execute key tasks.

Key Responsibilities: 

• Clinical Trial Design and Oversight:
  • Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods. 
  • Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
  • Perform data review, reconciliation and standardization to ensure high quality outputs 
  • Reviews clinical data to support in the assessment of the safety and efficacy of the investigational drug. 
  • Supports the development of clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports).
• Scientific Expertise:
• Maintains knowledge of the therapeutic area, disease state, and potential drug effects. 
• Assesses clinical data to help identify and analyze safety concerns and adverse events Stays current with relevant medical literature and clinical trial methodologies.
• Conducts literature reviews as needed for focused scientific questions or documentation.
• Cross-Functional Collaboration:
  • Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to ensure data integrity during the clinical development process. 

Qualifications:

• Advanced degree in life sciences, such as a PhD, PharmD or related field
• Understanding of clinical trial methodologies and regulatory requirements
• Experience in clinical study design, data analysis, data review and interpretation
• Good written and verbal communication skills
• Ability to work effectively in a collaborative, cross-functional environment
• 3 years experience

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 (remote may be considered) is $140,000 to $155,000. 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: 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.