Senior Clinical Project Manager

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.

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 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.

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.

Sobi is seeking a Senior Medical Director of Rheumatology to join the Medical Affairs team in Waltham. This role centers on setting direction for rheumatology initiatives and collaborating with leading experts in the field. Key responsibilities Shape the medical strategy for rheumatology within Medical Affairs Guide research efforts to support new and ongoing projects Work closely with top professionals in rheumatology to advance patient care Impact The Senior Medical Director will play a central role in improving patient outcomes and supporting the development of new treatments in rheumatology. Location This position is based in Waltham.

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.

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 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.

Join AbbVie’s Medical Affairs team and make a difference in the lives of patients battling ovarian solid tumors. Our organization is dedicated to providing healthcare professionals and patients with the vital information and solutions necessary to utilize AbbVie products safely and effectively throughout their healthcare journey.As the Scientific / Medical Director, you will play a pivotal role in shaping the strategic and operational aspects of our Oncology portfolio. Your expertise will contribute to healthcare interactions, the generation of clinical data, educational initiatives, and the safeguarding of patient safety through risk minimization and safety surveillance activities.This position requires close collaboration with our commercial and R&D teams, ensuring that medical insights drive our core medical, brand, and access strategies as we navigate the evolving therapeutic landscape.

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.

Join Deciphera Pharmaceuticals as a Medical Director of Pharmacovigilance, where you will play a pivotal role in ensuring the safety of our products. Reporting directly to the Senior Medical Director, this position is based in our Waltham office and is integral to our commitment to patient safety.As a Medical Director, you will oversee global pharmacovigilance activities for both marketed and investigational products. Your responsibilities will include the comprehensive review and analysis of safety data, identification of safety signals, and management of the benefit-risk profile for assigned compounds. You will keep senior management informed about safety issues and may represent Deciphera at various internal and external meetings.The ideal candidate will thrive in an entrepreneurial environment and demonstrate the flexibility to contribute to the safety understanding of our compounds throughout their lifecycle. You will engage with multiple levels of management and play a critical role in advancing our pharmacovigilance initiatives.Key Responsibilities:Lead ongoing safety surveillance, benefit-risk assessments, and risk management for assigned products.Provide pharmacovigilance expertise to support decision-making based on risk/benefit evaluations and data analysis.Conduct medical reviews of adverse event reports for both marketed and investigational products, ensuring adherence to procedures and timelines.Ensure consistent and high-quality medical interpretation in adverse event case assessments.Support cross-functional teams with protocol-related medical guidance, including safety topics and patient eligibility considerations.Contribute to the development of protocols, Investigative Drug Brochures, Informed Consent Forms, and Case Report Forms.Review trial-related adverse events and ensure consistency in assessment.Participate in team meetings and vendor discussions as necessary.Support audits and inspections as a subject matter expert for assigned programs.Provide training to team members and vendors regarding product safety and medical review processes.Complete tasks in a timely manner, notifying relevant parties of any necessary changes.Engage in scientific literature review for periodic safety reports and signal detection.

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.

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Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.

About Vita Global SciencesAt Softworld's Vita Global Sciences, we excel in providing professional services tailored to the life sciences sector. Our expertise includes clinical data analytics solutions and functional outsourcing services. Our dedicated team is skilled in Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and PK/PD analysis. We pride ourselves on our steadfast commitment to delivering outstanding results in a safe, compliant, and efficient manner.Our Ideal Candidate:We are looking for a dynamic Director of Business Development to lead the growth of our Life Sciences division from a remote setting. The successful candidate will adeptly manage geographic territories, identify and cultivate promising leads, craft persuasive proposals, and deliver influential presentations. Our primary focus is to provide exceptional consulting services to our esteemed clients. This role demands a high degree of professionalism and expertise, and we are excited to find an individual who can significantly contribute to achieving our objectives.

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.

Role Overview Crescent Biopharma is seeking a Senior Manager or Associate Director of Clinical Data Management based in Waltham, MA. This position leads data management activities for clinical trials, guiding teams to uphold data integrity and meet regulatory requirements. What You Will Do Direct and oversee data management operations for clinical studies. Ensure all processes align with regulatory standards and internal protocols. Work closely with cross-functional partners to improve data collection and analysis methods. Support the development of new therapies by maintaining high-quality clinical data. What Crescent Biopharma Looks For Strategic mindset with strong leadership abilities. Experience managing data in clinical trial settings. Commitment to data accuracy and regulatory compliance. Effective collaboration with diverse project teams.

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.

We are in search of a highly skilled Director of Biostatistics to take on the role of Study Statistician across several drug development programs. This pivotal position will involve crafting statistical strategies from the early stages of development through to regulatory submissions, collaborating cross-functionally to facilitate data-driven decision-making while upholding scientific and regulatory standards.Key ResponsibilitiesDevelop and oversee statistical strategies for various clinical studies throughout all phases of development.Contribute to Clinical Development Plans and represent Biostatistics in cross-functional teams.Design clinical studies, author and review protocols and Statistical Analysis Plans (SAPs), and supervise interim and final analyses.Ensure the quality, accuracy, and reproducibility of statistical outputs in partnership with programming teams and CROs.Assist with regulatory submissions (including INDs, NDAs, BLAs, MAAs), including interactions with health authorities and integrated summaries (ISS/ISE).Oversee external vendors and mentor junior statisticians or contractors.Contribute to scholarly publications, conference presentations, and continuous improvement initiatives.