Associate Director, Pharmacovigilance Scientist

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.

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

Deciphera Pharmaceuticals, Inc. is on the lookout for a seasoned Associate Director of Sales Operations to spearhead and enhance our field-facing operational strategies. This pivotal role will support the establishment of a high-performing Commercial field team, particularly focused on facilitating a successful brand launch. The successful candidate will ensure compliance, efficiency, and data-driven insights within field operations across our Hematology Franchise, playing a crucial role in ensuring operational readiness for product launches and ongoing excellence initiatives in the field.Key ResponsibilitiesFormulate and implement field operations strategies that align with both commercial and medical objectives.Manage field technology platforms including CRM systems, roster management, and reporting tools in collaboration with the IT department.Oversee territory design, roster management, and alignment processes to ensure compliance with coverage models.Coordinate onboarding operations with Training, HR, and Compliance teams.Direct the creation of field reports, dashboards, KPI tracking, and business insights.Ensure all field operations processes adhere to FDA, OIG, and corporate compliance standards.Lead continuous improvement initiatives aimed at enhancing scalability, efficiency, and quality.Collaborate effectively across functions including Sales, Marketing, Medical, Compliance, IT, HR, Legal, and Finance.

Deciphera Pharmaceuticals is looking for a dynamic and strategically minded Associate Director of Global Site Contracts, Budgets, and Payments to spearhead our global site contracting and investigator grant initiatives across our clinical programs. This pivotal role is essential for ensuring the timely initiation and execution of studies by providing finalized site agreements, budgets, and payment plans that are in sync with corporate and program timelines. Key Responsibilities:Act as the go-to expert and primary point of escalation for global site contracts, budgets, and payments.Lead the creation of investigator grant budgets, payment terms, and contracting strategies.Manage contract tracking, documentation, and compliance within our internal systems and with external partners.Offer oversight and support to study teams and CROs during feasibility, startup, maintenance, and closeout phases.Collaborate across functions with Clinical Operations, Legal, Compliance, Finance, and CROs to facilitate efficient study startup and lifecycle execution.Participate in bid defenses, joint operating committees (JOCs), kickoff meetings, and other program discussions.Drive department initiatives, implement process enhancements, and mentor team members.Willingness to travel up to 25% as required.

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.

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.

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: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.

At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.

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.

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.

The Associate Director of Commercial Effectiveness & Training will play a pivotal role in designing and delivering impactful training programs aimed at enhancing the knowledge and competencies of customer-facing teams, including Field Sales, Account Managers, and Infusion Educators. Reporting directly to the Director of Commercial Effectiveness & Training, this position is crucial in preparing Sobi for the anticipated product launch in 2026.Collaborating closely with Field Leadership, the Brand Team, and various cross-functional partners, the Associate Director will spearhead the planning and execution of onboarding training initiatives that equip teams for launch readiness and long-term success.Preference will be given to candidates based in the Boston area.Key Responsibilities:Coordinate and facilitate new hire training sessions, both virtual and in-person.Develop, implement, and facilitate training programs and workshops for National Sales and Plan of Action (POA) meetings as necessary.Identify learning gaps and collaborate with the Director of Commercial Effectiveness & Training to create effective content aimed at improving outcomes for our field teams.Oversee processes related to the Medical, Legal, and Regulatory review of training materials.Perform additional duties as assigned.

Join Sobi as an Associate Director of Access Strategy, where you will play a critical role in shaping access strategy initiatives that enhance patient access to innovative therapies. Collaborate with cross-functional teams to develop comprehensive strategies that address barriers to access and ensure that patients receive the treatments they need. Your expertise will influence strategic decision-making and drive successful outcomes in the evolving healthcare landscape.

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.

AbbVie is seeking an accomplished Associate Director in Regulatory Affairs CMC to lead and oversee regulatory strategies for our product portfolio. In this role, you will be responsible for the preparation and submission of regulatory documents, ensuring compliance with evolving regulations and guidelines.You will collaborate with cross-functional teams, providing expertise in CMC (Chemistry, Manufacturing, and Controls) regulatory matters while driving initiatives that align with our company’s mission to advance patient care.The ideal candidate will possess a strong background in regulatory affairs within the pharmaceutical or biotechnology industry, with proven experience in product submissions to regulatory authorities.

Deciphera Pharmaceuticals is excited to invite applications for the role of Associate Director of Program Leadership & Management. In this pivotal position, you will provide exceptional leadership and strategic direction to our Development and Commercial Program Teams. Collaborating closely with the Program Lead, you will be instrumental in advancing programs from early to late-phase clinical development and lifecycle management. The ideal candidate will exhibit a comprehensive understanding of drug development, thrive in ambiguous situations, and possess outstanding communication skills to foster effective collaboration within program teams and across the organization.This role demands a high level of cross-functional teamwork, engaging with both internal and external partners. You will be responsible for leading daily program management activities, including the formulation and implementation of the program's Integrated Development Strategy. A deep understanding of overall program strategy and critical path activities, as well as risk identification and mitigation planning, is essential.Key ResponsibilitiesStrategic Partnership with the Program Lead (50%)Collaborate with the Program Lead to develop and execute strategic, integrated development plans through effective leadership of Program Teams.Provide clear guidance on product development requirements to align with the expectations of external customers and business stakeholders.Monitor program progress and related KPIs, identifying gaps and risks while offering strategic recommendations.Support the execution and ongoing reassessment of development strategies in line with the overall corporate strategy.Operational Excellence Across Program Teams (50%)Facilitate program team meetings to ensure productive and efficient discussions.Ensure timely and clear communication of program strategies and progress to relevant stakeholders.Coordinate the integration of sub-teams to enhance the effectiveness of Program Teams.