Clinical Project Manager - Lead Innovative Clinical Trials

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 ext…

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.

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.

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 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.

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.

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.

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.

AbbVie is seeking an accomplished and visionary leader for the position of Head of Asset in Lung, Oncology Clinical Development. This executive role offers the opportunity to drive innovative clinical strategies and oversee pivotal clinical trials related to lung oncology. The successful candidate will possess a deep understanding of oncology drug development and will lead a talented team to advance our pipeline and improve patient outcomes.

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 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.

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

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.

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.

Join AbbVie as the Head of Asset in Lung Oncology Clinical Development, where you will spearhead innovative clinical strategies to advance our groundbreaking therapies in oncology. In this pivotal role, you will lead a talented team, collaborate with cross-functional stakeholders, and drive the development of our lung cancer asset portfolio. Your expertise will guide clinical trial designs, ensuring they align with regulatory standards and address the needs of patients and healthcare providers alike.

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.

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.

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.

Are you excited about the prospect of working closely with a dedicated sponsor while enjoying the stability and diverse career avenues that a global CRO provides? Our team believes it’s the ideal combination... ClinChoice is on the lookout for a Manager of Statistical Programming to join our client’s team in a permanent capacity—an extraordinary opportunity to spearhead significant statistical strategies in an engaging environment. This is a Hybrid position, with a preference for candidates who can commute to our client’s location in Waltham, MA. Role Overview We are in search of a seasoned and driven Manager of Statistical Programming to oversee programming initiatives within the Biometrics department. This role will be responsible for managing clinical programming deliverables, ensuring quality and compliance, facilitating regulatory submissions, and mentoring a team of programmers. The ideal candidate will possess strong proficiency in SAS (and/or R), comprehensive knowledge of CDISC standards, experience with oncology clinical trials, and exceptional leadership capabilities. Key Responsibilities:

We are seeking a visionary leader to join AbbVie as the Head of Asset in Lung, Oncology Clinical Development. In this pivotal role, you will spearhead the strategic direction and execution of clinical programs focusing on lung cancer therapies. Your expertise will guide a talented team in advancing innovative treatments that significantly improve patient outcomes.