Medical Director, Clinical Development

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.

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 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 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 Overview Sobi is hiring a Senior Medical Director of Rheumatology for its Medical Affairs team in Waltham. This position focuses on shaping strategy, guiding research efforts, and working closely with top professionals in rheumatology. The work directly impacts patient care and helps advance new treatments in the field.

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.

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 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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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.

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.

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.

Crescent Biopharma is on a mission to establish itself as a leading force in oncology, dedicated to innovating the next generation of cancer therapies. Our clinical-stage pipeline features groundbreaking initiatives, including a PD-1 x VEGF bispecific antibody and advanced antibody-drug conjugates. By integrating diverse modalities and targeting established pathways, Crescent is poised to accelerate the development of transformative treatments, either as standalone options or in combination therapies, aimed at addressing various solid tumors.For further details, visit our website at www.crescentbiopharma.com and connect with us on LinkedIn.

Zenas Bio is a pioneering clinical-stage global biopharmaceutical company dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune diseases. Our strategic approach is rooted in the expertise of our seasoned leadership team, combined with a rigorous methodology for acquiring and developing promising product candidates worldwide. We are advancing two late-stage molecules, obexelimab and orelabrutinib, which we believe have the potential to provide significant clinical benefits. Obexelimab, our flagship candidate, is a bifunctional monoclonal antibody targeting both CD19 and FcγRIIb, designed to inhibit the activity of B cells implicated in various autoimmune diseases while preserving them. The unique administration method of obexelimab as a self-injected subcutaneous treatment may effectively tackle the underlying mechanisms involved in chronic autoimmune conditions. Orelabrutinib stands out as a potentially best-in-class oral Bruton’s Tyrosine Kinase (BTK) inhibitor, offering a highly selective approach to managing CNS-penetrant inflammation and disease progression in Multiple Sclerosis (MS). Additionally, Zenas is developing early-stage candidates, including an innovative oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both showing promise in the field.We are in search of 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. Join our fast-paced environment where you will have the chance to grow both personally and professionally while contributing to our mission of leading the charge in immunology and autoimmune disease treatment, grounded in our core values of Transparency, Relationships, Urgency, Excellence, and TRUE Innovation!Territory: MidAtlantic (NY, NJ, PA, OH)Position Summary:The Associate Director, Medical Science Liaison (MSL) for Rheumatology at Zenas Bio serves as the field-based representative of our Medical Affairs team. MSLs are scientifically trained professionals with robust clinical and scientific backgrounds, committed to providing the healthcare community with balanced, scientifically rigorous information. This role reports directly to the Executive National Director of US MSLs.Key Responsibilities:Identify, establish, and nurture professional relationships with international, national, regional, and local key opinion leaders and allied healthcare professionals.

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 biologic therapies aimed at transforming the treatment landscape for chronic skin conditions. Our mission is to empower individuals suffering from chronic skin diseases, such as plaque psoriasis, by providing unprecedented freedom from their ailments through treatments administered as infrequently as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies developed by Paragon Therapeutics, targeting the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory disorders. For more details, visit www.orukatx.comAs we fortify our core team, we are on the lookout for exceptional talent across various domains. We seek individuals who are not just looking for employment, but are eager to contribute to a larger purpose. If you are passionate about making a significant impact and are keen on fostering an engaged, inclusive, and positive workplace culture, we want to hear from you.Job Title: Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)Location: Hybrid – Waltham, MA. Candidates are expected in the office 3 days a week. Remote considerations may apply.Role Overview:The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities that support the development, validation, and lifecycle management of biologic drug products, particularly monoclonal antibodies. This position will oversee method validation and comparability initiatives essential for BLA/MAA submissions, process modifications, and commercial readiness, collaborating closely with CMC, Quality, Regulatory Affairs, and external partners.The ideal candidate is a proactive leader with extensive experience in analytical method validation, device functional testing, and regulatory frameworks for late-stage biologics. You will guide teams through intricate technical and compliance milestones, making this a highly visible role within the CMC team. Join our expanding organization and play a crucial part in supporting multiple programs’ analytical activities, facilitating the release of supplies for clinical trials, and preparing for commercialization in the US, Canada, and EU.