Clinical Scientist, Clinical Development

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologic therapies for chronic skin conditions. The company focuses on giving patients with diseases like plaque psoriasis greater freedom through infrequent dosing, just once or twice a year. Oruka’s pipeline features proprietary antibodies from Paragon Therapeutics, designed to address the underlying mechanisms of plaque psoriasis and other dermatologic or inflammatory disorders. Learn more at www.orukatx.com. Position Details Title: Clinical Scientist, Clinical Development (Multiple openings) Location: Hybrid (Waltham, MA) with an expectation of three days per week in the office. Remote candidates will also be considered. Role Overview The Clinical Scientist plays a key role in planning and executing clinical trials. This position supports the development of study protocols, assists with implementation, reviews clinical data, and helps prepare documentation to meet clinical development goals. The Clinical Scientist works closely with cross-functional teams and reports directly to the Medical Director of Clinical Development to help deliver high-quality clinical data. Main Responsibilities Clinical Trial Design and Oversight: Help develop clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods. Monitor clinical trial data at study sites to ensure adherence to protocols and Good Clinical Practice (GCP) standards.

Role OverviewWe are on the lookout for a highly motivated and strategic Medical Director, Clinical Development to spearhead our clinical development initiatives across various early- and late-stage programs. This essential position presents a unique opportunity to influence clinical strategy, act as a medical monitor, and work collaboratively across departments to ensure successful execution. The role also involves mentoring clinical scientists and contributing to business development and process enhancements as per organizational needs.Primary ResponsibilitiesLeadership in Clinical Development (75%)Direct clinical strategy and oversee execution for multiple programs; serve as the medical monitor while managing study-level activities.Collaborate with clinical science and safety teams to conduct data reviews; author clinical and regulatory documents, including protocols, Investigator's Brochures (IBs), and Investigational New Drug applications (INDs).Engage with Key Opinion Leaders (KOLs), facilitate advisory boards and steering committees, and support scientific publications.Present findings to executive leadership and contribute to the scientific and commercial progress of our pipeline assets.Cross-Functional Collaboration & Organizational Contribution (25%)Work collaboratively across functions to ensure alignment, effective communication, and operational excellence across teams, as well as between Ono and Deciphera.Provide clinical insights for target assessments, business development activities, and strategic initiatives.Support Medical Affairs and act as a clinical liaison for study sites and internal stakeholders.Take part in continuous improvement initiatives and promote a culture of collaboration within the company.

Role Overview:The Director of Clinical Operations plays a pivotal role in ensuring that clinical stage programs meet both strategic and operational objectives in compliance with set timelines, budgets, and quality standards. This leadership position is vital in guiding the Clinical Operations team, shaping clinical program strategies, and fostering collaboration and transparency across multiple functions. The Director will work closely with both internal stakeholders and external partners to facilitate high-quality clinical trial execution within the dynamic landscape of a small-to-midsize biotech organization.Key Responsibilities:Program Strategy & Leadership (35%)Formulate and implement clinical program strategies that are aligned with corporate objectives. Lead the Clinical Operations team to optimize the allocation of resources across various programs.Clinical Trial Oversight (25%)Ensure that clinical trials are meticulously defined, planned, and executed in accordance with GCP, ICH, and FDA regulations. Monitor study timelines, budgets, and quality metrics to drive operational excellence.Regulatory & Documentation Support (15%)Assist in drafting key regulatory documents, ensuring that clinical program outputs meet submission requirements and regulatory standards.Vendor & CRO Management (15%)Oversee and manage Contract Research Organizations (CROs), vendors, and external partners to ensure that performance, deliverables, and financial accountability align with expectations.Team Development & Collaboration (10%)Cultivate a collaborative environment within Clinical Operations and exemplify leadership values. Encourage transparent communication, accountability, and operational discipline across the department.Other duties as assigned.

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics that aim to revolutionize the treatment of chronic skin diseases. Our mission is to empower patients suffering from conditions like plaque psoriasis with unprecedented freedom from their ailments by achieving complete disease clearance with treatment regimens as infrequent as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies, engineered by Paragon Therapeutics, targeting the fundamental mechanisms behind plaque psoriasis and other dermatological and inflammatory disorders. For more detailed information, please visit www.orukatx.com.As we cultivate our core team, we are in search of exceptional talent across various functional areas—individuals who are not merely seeking a job but are enthusiastic about being part of a larger vision. We seek those who are passionate about making a meaningful impact and are eager to contribute to fostering an engaged, inclusive, and positive company culture.Role Overview:The Clinical Trial Manager/Senior Clinical Trial Manager will be responsible for ensuring compliance with trial protocols, regulatory requirements, and overall trial execution.

Join our team as a Clinical Project Manager at Deciphera Pharmaceuticals, where you will play a critical role in steering the planning, execution, and successful delivery of clinical trials. This position involves managing small to mid-sized studies while also supporting larger, more complex programs by effectively coordinating cross-functional teams and external partners. Your leadership will ensure trials are completed on schedule, within budget, and meet the highest quality standards.Key Responsibilities:Drive successful clinical trial delivery by supporting cross-functional study execution teams.Provide strategic oversight and address operational challenges and risks proactively.Manage study timelines, resources, and deliverables to meet quality, cost, and scheduling expectations.Oversee the performance of CROs and external vendors to ensure compliance with contractual and operational requirements.Support study feasibility, including patient enrollment strategies, site selection, and data collection planning.Contribute to protocol development and ensure alignment with program objectives during study execution.Implement effective risk mitigation strategies to enhance trial outcomes.

Zenas is a pioneering clinical-stage global biopharmaceutical firm devoted to leading the way in the development and commercialization of groundbreaking therapies for patients suffering from autoimmune diseases. Our strategic approach integrates our seasoned leadership with a meticulous product acquisition strategy to identify, acquire, and develop product candidates worldwide that can deliver exceptional clinical benefits to those affected by autoimmune conditions. Currently, Zenas is propelling two advanced-stage potential franchise products, obexelimab and orelabrutinib. Obexelimab, our flagship candidate, is a bifunctional monoclonal antibody engineered to bind to both CD19 and FcγRIIb—markers prevalent across B cell lineages—to modulate the activity of cells involved in various autoimmune disorders without causing depletion. We believe that obexelimab's innovative mechanism of action and its self-administered subcutaneous injection regimen can effectively target the pathogenic roles of B cell lineages in chronic autoimmune diseases. Orelabrutinib is an orally administered, highly selective CNS-penetrant Bruton’s Tyrosine Kinase (BTK) inhibitor that may address localized inflammation and disease progression in Multiple Sclerosis (MS). Additionally, Zenas is advancing early-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a preclinical oral brain-penetrant TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in the global acquisition, development, and commercialization of pharmaceutical products. Our team members have the opportunity to thrive in a dynamic learning environment, contributing to both personal and organizational success as we strive to become a global leader in immunology and autoimmune diseases, all while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation—what we call TRUE Innovation!Position Summary: The Medical Director, Clinical Development in Neurology will play a pivotal role in the development and execution of essential initiatives within the Neurology Therapeutic Area in our Clinical Development department. This team is responsible for overseeing Phase I-III clinical research and providing the company with vital medical and scientific expertise related to the therapeutic area. The Director will act as a key resource for the VP of Clinical Development in Neurology and serve as a medical authority concerning products advancing through various phases of drug development.

Deciphera Pharmaceuticals is seeking a highly skilled and experienced Senior Medical Director of Clinical Development to lead our clinical research initiatives. In this pivotal role, you will oversee the design and execution of clinical trials and collaborate closely with cross-functional teams to advance our innovative therapies. The ideal candidate will have a deep understanding of clinical development processes and a proven track record in leading successful trials.

Role Overview:The Senior Clinical Project Manager is responsible for steering and overseeing intricate clinical trials, showcasing extensive expertise in clinical operations methodologies. This position requires exemplary organizational and leadership skills, coupled with strategic acumen. The individual will provide operational guidance, supervision, and excellence in execution to guarantee the timely, budget-compliant, and regulatory-compliant delivery of clinical studies, adhering to GCP, ICH, and FDA standards. The Senior Clinical Project Manager collaborates across departments to align study goals with program objectives while driving process enhancement initiatives within a dynamic small-to-midsize biotech setting.Key Responsibilities:Clinical Trial Leadership & Execution (40%)Direct the planning, execution, and successful delivery of clinical trials within established quality, time, and budget constraints. Supervise cross-functional team (CFT) performance, ensuring operational alignment with Clinical Operations objectives, while concurrently managing multiple studies.Cross-Functional Team Management (25%)Lead and mentor cross-functional study teams (CFTs), promoting collaboration, accountability, and problem-solving across various functions. Delegate responsibilities effectively to support staff as necessary.Vendor & CRO Oversight (15%)Manage discussions and negotiations with CROs and vendors to ensure compliance with contractual obligations, budget constraints, and study timelines. Actively identify and mitigate operational risks to guarantee high-quality outputs.Process Optimization & Strategic Execution (10%)Assess current methodologies and pinpoint opportunities for enhanced efficiency and effectiveness across clinical operations processes and systems.Stakeholder Communication & Engagement (10%)Update internal stakeholders on study progress, challenges, and outcomes, ensuring transparency and alignment with program leadership and clinical operations management.Other duties and responsibilities as assigned.

About Us:At Oruka Therapeutics (Nasdaq: ORKA), we are pioneering innovative biologics aimed at transforming the treatment landscape for chronic skin disorders. Our mission is to empower individuals battling chronic skin conditions, such as plaque psoriasis, by providing them with the utmost freedom from their ailments, achieving significant disease clearance through infrequent dosing, potentially just once or twice yearly. Our proprietary collection of antibodies, meticulously crafted by Paragon Therapeutics, targets the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory conditions. To learn more, visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas—individuals who seek more than just employment, but rather a chance to be part of something transformative. We value passion for making a difference and contributions to fostering an engaged, inclusive, and positive workplace culture.Job Title: Director of Clinical Quality AssuranceLocation: Remote; candidates located in the Waltham, MA area are preferred.Role Overview:The Director of Clinical Quality Assurance will provide strategic leadership and oversight for Oruka's clinical development initiatives, focusing primarily on Good Clinical Practice (GCP) and associated quality systems that support clinical trials. This role will establish, enhance, and oversee clinical quality processes appropriate to each phase, ensuring comprehensive supervision of clinical trial execution and vendor performance while preparing for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.This position will collaborate closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure compliance with GCP, relevant global regulations, internal procedures, and protocol requirements throughout the clinical trial lifecycle. The Director of Clinical QA will proactively contribute quality insights, support continuous improvement initiatives, and help cultivate a quality-centric culture as the organization progresses with its pipeline.Key Responsibilities:Clinical Quality Oversight: Ensure compliance with GCP and applicable regulatory requirements for new and ongoing clinical studies.

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologic therapies for chronic skin diseases, with a focus on achieving complete disease clearance for patients with conditions like plaque psoriasis. The company’s antibody portfolio, created in partnership with Paragon Therapeutics, targets the underlying mechanisms of dermatologic and inflammatory diseases. Oruka’s goal is to offer patients long-lasting relief, potentially with just one or two treatments per year. Learn more at www.orukatx.com. Position Details Title: Director/Senior Medical Director, Clinical Development (Multiple openings) Location: Remote or hybrid. For those near Waltham, MA or Menlo Park, CA, hybrid work is available (3 days per week in office). Role Overview The Director or Senior Medical Director, Clinical Development, leads and supports clinical trials across Oruka’s pipeline. This role shapes clinical study design, oversees trial execution, and interprets data to validate product safety and efficacy. Collaboration with internal teams and external partners is central, ensuring clinical activities align with regulatory, scientific, and business goals. Main Responsibilities Clinical Trial Design and Oversight: Help develop clinical trial protocols, including patient selection, study endpoints, and data collection plans. Oversee the conduct of clinical trials at study sites, ensuring adherence to protocols and Good Clinical Practice (GCP) standards. Review and interpret trial data to evaluate the safety and efficacy of investigational products.

About Us:Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologics aimed at redefining the treatment landscape for chronic skin conditions. Our mission is to provide individuals afflicted by chronic skin diseases, such as plaque psoriasis, with unparalleled freedom from their ailments through therapies that may require administration only once or twice annually. We are advancing a unique portfolio of potentially leading antibodies, engineered by Paragon Therapeutics, that target the fundamental mechanisms of plaque psoriasis and other dermatologic and inflammatory conditions. To learn more, please visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas. We seek individuals who are not only searching for employment but also aspire to be part of a transformative mission. If you are passionate about making a meaningful impact and are eager to help cultivate a vibrant, inclusive, and positive organizational culture, we encourage you to apply.Job Title: Senior Clinical Trial ManagerLocation: Hybrid – Waltham, MA. Candidates are expected to work in the office 3 days per week.Role Overview:The Senior Clinical Trial Manager will act as the clinical functional lead, spearheading clinical trial initiatives for Oruka's innovative dermatological treatments. You will be responsible for ensuring compliance with trial protocols, regulatory standards, and operational efficiency while collaborating with cross-functional teams to propel Oruka's clinical pipeline forward. A Senior Clinical Trial Manager is expected to manage the clinical trial independently, effectively planning and executing the study to guarantee the quality of deliverables within the specified budget and timeline.Key Responsibilities:Clinical Trial Management:Lead and oversee multiple clinical trials from initiation through completion, ensuring compliance with study timelines and financial parameters.Collaborate with investigators, vendors, and cross-functional teams to assure excellent study execution and operational performance.Supervise the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.

As a Senior Manager of Clinical Data Management at Deciphera Pharmaceuticals, you will lead and oversee the clinical data management function, ensuring high-quality data collection and management practices. You will play a pivotal role in supporting clinical trials through the oversight of data management processes, and collaborate with cross-functional teams to ensure timely and accurate delivery of data for analysis.

Crescent Biopharma is dedicated to transforming the oncology landscape by developing cutting-edge therapies for cancer patients. Our clinical-stage pipeline boasts innovative programs, including a PD-1 x VEGF bispecific antibody and advanced antibody-drug conjugates. By harnessing multiple therapeutic modalities and targeting established pathways, we strive to expedite the delivery of potentially groundbreaking treatments, whether as standalone therapies or in combination regimens aimed at various solid tumors. To learn more about our initiatives, visit www.crescentbiopharma.com and connect with us on LinkedIn and Twitter.

Role Overview Crescent Biopharma seeks a Director or Senior Director of Clinical Business Operations in Waltham, MA. This leader guides clinical operations strategy and oversees a team dedicated to the execution of clinical trials. The role involves close collaboration with multiple departments to keep projects on track and compliant with regulatory standards. Key Responsibilities Shape and refine clinical operations strategy Lead and mentor the clinical business operations team Work cross-functionally to support clinical trial execution Optimize processes and manage operational resources Maintain compliance with all relevant regulatory requirements

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics that aim to set a new standard for treating chronic skin conditions. The company’s mission centers on helping patients with diseases like plaque psoriasis achieve lasting relief and, in some cases, complete disease clearance with infrequent dosing, potentially just once or twice a year. Oruka’s pipeline features proprietary antibodies, engineered by Paragon Therapeutics, that target the underlying mechanisms of plaque psoriasis and other dermatologic and inflammatory disorders. More information is available at www.orukatx.com. Position Details Title: Associate Director of Clinical Operations Location: Waltham, Massachusetts (hybrid schedule: 3 days per week onsite) Role Overview Oruka Therapeutics seeks an Associate Director of Clinical Operations to manage all aspects of trial setup and execution. This role supports the Director of Clinical Operations within a designated therapeutic area and involves oversight of multiple studies. The position calls for someone who can balance strategic planning with hands-on involvement, ensuring clinical programs stay on schedule and within budget. The Associate Director will handle operational details, anticipate and address challenges, and implement solutions to keep trials moving forward. Success in this role requires integrity, practical judgment, and a strong commitment to study goals. The ability to shift between leadership and direct involvement, a true player/coach approach, is essential. This is a hands-on, collaborative role within a biotech setting that values adaptability and resourcefulness. The environment offers frequent opportunities for learning and growth alongside a team committed to a positive and inclusive culture.

Deciphera Pharmaceuticals, Inc. is hiring a Senior Manager, Clinical Quality Assurance in Waltham. This position leads the Clinical Quality Assurance team and plays a central role in maintaining high standards for clinical trial quality and regulatory compliance. Role Overview The Senior Manager, Clinical Quality Assurance develops and implements quality assurance strategies for clinical programs. The role involves oversight of compliance with regulatory requirements and internal quality expectations throughout all phases of clinical trials. Key Responsibilities Lead the Clinical Quality Assurance team Develop and execute quality assurance strategies for clinical trials Conduct audits to assess compliance with regulatory standards Ensure all clinical trial activities meet regulatory and company quality requirements What We’re Looking For Extensive experience in clinical quality assurance Strong knowledge of regulatory requirements for clinical trials Proven ability to develop and implement quality assurance processes Experience conducting audits in a clinical setting

Join the innovative team at Biocytogen, where we are dedicated to advancing the field of antibody drug development. We are actively seeking talented and driven scientists to enhance our antibody discovery team. This pivotal role focuses on optimizing therapeutic antibody binders derived from our cutting-edge RenBiologics program, which boasts a comprehensive library of therapeutic antibodies targeting a vast array of druggable genes. The ideal candidate will apply state-of-the-art antibody engineering methods to enhance binding affinity, specificity, stability, and therapeutic efficacy. Your contributions will play a vital role in the development of antibodies across multiple therapeutic domains, including immuno-oncology, inflammatory and autoimmune disorders, neurology, cardiovascular diseases, and metabolic conditions.

Explore exciting career opportunities in the clinical and medical support sectors at New England Donor Services. We are dedicated to enhancing organ donation and transplantation efforts, and we seek passionate individuals to join our team. As a leader in organ operations, you will play a crucial role in supporting our mission to save lives.

Oruka Therapeutics develops biologic treatments for chronic skin conditions, including plaque psoriasis. The company’s approach centers on infrequent dosing and proprietary antibodies designed to address dermatologic and inflammatory disorders. Oruka is headquartered in Waltham, Massachusetts, and operates as a publicly traded company (Nasdaq: ORKA). Role overview The Senior Manager, Clinical Supply Chain (Biologics) leads supply chain operations for clinical trials spanning early to late development stages. This hybrid role is based in Waltham, MA, with an on-site presence required three days per week. The position reports to the head of Clinical Supply Chain and supports multiple trials in the US, Canada, and the EU. Key responsibilities include managing labeling, packaging, distribution, inventory, forecasting, and handling supply expiration. The Senior Manager also oversees IRT (Interactive Response Technology) initiation and maintenance. Collaboration with CMC, Clinical, Program Management, Regulatory, and Quality teams is central to the work, as is helping to establish supply chain best practices and processes. The scope covers global activities, with particular attention to supplies such as vials and pre-filled syringes. Key responsibilities Carry out clinical supply chain tasks, including labeling, packaging, and inventory management. Oversee distribution, forecasting, and supply expiration for clinical trials. Initiate and maintain IRT systems to support trial operations. Work closely with cross-functional teams to ensure alignment and compliance. Support development and implementation of supply chain processes and best practices. Requirements Experience managing clinical supply chain operations for biologics, ideally across multiple regions. Strong communication skills and a results-oriented approach. Ability to work effectively with cross-functional teams and external partners. Familiarity with clinical trial supply needs, especially for vials and pre-filled syringes. Hybrid work schedule: in-office presence in Waltham, MA, three days per week. For more about Oruka Therapeutics, visit www.orukatx.com.

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions. The company’s mission centers on helping patients with diseases like plaque psoriasis achieve lasting relief, aiming for high rates of disease clearance with infrequent dosing, sometimes just once or twice a year. Oruka’s portfolio features proprietary antibodies from Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatologic or inflammatory disorders. More information is available at www.orukatx.com. Role Overview: Scientist/Senior Scientist, Upstream Process Development & Manufacturing (Biologics) Oruka Therapeutics is hiring a Scientist or Senior Scientist to support upstream manufacturing operations in Waltham, Massachusetts. This position focuses on process development and the delivery of clinical trial materials produced at Contract Development and Manufacturing Organizations (CDMOs). The role works closely with the CMC team and collaborates with colleagues in downstream processing, analytical development, drug product, Quality Assurance, regulatory affairs, and program management. This position contributes to CMC strategy and supports the development of biotherapeutics in an innovative and growing team environment.