Senior Director/Medical Director, Clinical Trial Lead

About Jade Biosciences  Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com [jadebiosciences.com] and follow the Company on LinkedIn [https://www.linkedin.com/company/jade-biosciences/].   Role Overview  The Director, Clinical Operations will oversee the strategic and operational execution of clinical trials, leading cross-functional teams and collaborating with internal stakeholders and external vendors. This individual will manage trial budgets, vendor selection, and risk mitigation while contributing technical input to key clinical documents. This individual will also mentor staff, foster strong team and cross-functional relationships, and nimbly adapt in our dynamic organization. With proven leadership, financial acumen, and problem-solving skills, this individual will thrive in Jade’s dynamic environment and evolve to support broader corporate initiatives. This is an exciting opportunity to make significant contributions to Jade’s immunology pipeline, leading trials from first in human single site to global (APAC, LATAM, etc.) phase 3, as assigned.   Key Responsibilities  * Performs role of Clinical Operations trial lead for assigned trials and leads cross-functional Study Execution Teams  * Develops and executes trial operational strategies and partners cross-functionally to drive trial execution forward; provides strategic and technical recommendations to senior leadership  * Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors), directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments and partners with CROs and other vendors to deliver on study execution  * Creates and tracks clinical trial budgets  * Directs risk mitigation, escalation, and resolution activities both internally and with sites and vendors  * Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports)   * Builds relationships with clinical sites, vendors, and key stakeholders and maintains an understanding of the external landscape and adjusts plans accordingly  * Represents Clinical Operations in cross-functional activities and supports development and management of the Clinical Operations function  * Mentors more junior team members such as Clinical Trial Associates  * Effectively builds strong internal teams and cross-functional relationships and demonstrates leadership and team building skills, along with success in proactive risk mitigation and problem solving  * Flexible and creative in meeting the needs and challenges of a growing, dynamic company and demonstrates excellent problem-solving abilities  * Strong financial acumen with outstanding track record of building budgets and managing expenses to budget  * Contributes to corporate activities, including preparation of materials for Executive Team and Board of Director meeting materials  Qualifications  * Bachelors + 15 years of related experience, or Masters + 12 years of related experience  * 10+ years of clinical research experience, including 7+ years of trial management within a biopharmaceutical company; 5+ years within a small/startup company is a plus  * Exceptional clinical trial management skills with a focus on strategic oversight of trial execution on time and on budget, study coordinator and/or site monitoring experience a plus  * Extensive phase 1 through phase 3, global trial management experience  * Immunology and/or rare disease trial management experience   * Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc)  * Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials  * Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development   * Experience managing, coaching, and mentoring personnel  * Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration  Position Location  This is a remote role; periodic travel to team and company events is required.  The anticipated salary range for candidates for this role is $215,000 - $240,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.  As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster [https://www.e-verify.gov/sites/default/files/everify/images/manuals/EVParticipationPoster.JPG]. Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.   As Study Success Director for CEE, you will be the key link between Iterative Health’s European site network and the sponsors, local affiliates, and CROs running studies across the region. As we scale in Central and Eastern Europe, you will give sponsors a single, trusted counterpart who understands both their study priorities and the operational realities of delivering them locally. You will help ensure that studies are launched effectively, site performance is clearly understood, and local execution risks are surfaced and resolved early. You will also play an important role in making Iterative Health’s value proposition clear and credible to regional sponsor audiences, helping strengthen sponsor trust, study retention, and our position as a preferred network partner in CEE. Reporting directly to the European leadership, you will bring strong sponsor-facing experience, sound operational judgment, and the communication skills to operate confidently across sponsor, CRO, and site teams. Location: Warsaw, Poland Employment Type: Full-Time EOR Compensation: PLN 379,800 – PLN 485,386.85 gross annual base salary, plus annual bonus and benefits. Final compensation will be determined based on experience, skills, and internal equity. Benefits: Private medical coverage, life insurance, retirement benefits, paid time off, etc. Where You’ll Drive Impact  Sponsor & CRO Engagement * Serve as the primary Iterative Health point of contact for sponsors and local affiliates, as well as CRO country teams across CEE — owning the relationship and ensuring consistent, high-quality engagement throughout the study lifecycle. * Work closely with European leadership to build and maintain trusted relationships with key regional decision-makers at sponsor and CRO organizations, positioning IH as the partner of choice for new and ongoing studies. * Ensure study kickoffs are well-structured, clearly documented, and set expectations from day one. * Track and report site performance, risks, and follow-up actions accurately, addressing them through regular alignment cadences with sponsors and CROs. * Drive regional network growth by cultivating IH's presence and reputation with existing sponsors and CROs across CEE. * Improve sponsor satisfaction, study retention, and IH's share of new studies within existing sponsor relationships over time. Stakeholder Mapping & Engagement * Build and execute, together with European leadership, a comprehensive stakeholder map and engagement plan for each active and pipeline sponsor and CRO across the region. * Ensure coverage of all key stakeholder types — medical, operational, regulatory, and procurement — with a clear engagement cadence and documented relationship history. Study Kickoff & Coordination Materials * Lead the development of study-specific kickoff materials, RACIs, and communication frameworks that set clear expectations between IH, sponsor, CRO, and site teams from day one. * Facilitate sponsor and CRO kickoff meetings, ensuring IH's role, responsibilities, and value are clearly communicated at the outset of each study. * Educate sponsors early on IH's operating model, site capabilities, and network standards to set the right expectations and reduce misalignment during execution. Service Delivery Credibility & Sponsor Trust * Partner across teams to build and maintain an evidence-based service narrative, translating site performance, activation timelines, and execution track record into materials that build sponsor and CRO confidence. * Understand regional sponsor and CRO needs and help translate them into concrete services IH can offer going forward. * Support business development by equipping sponsors with credible, current evidence of IH's network performance, site quality, and delivery track record. * Respond to sponsor and CRO questions about IH's capabilities with accurate, up-to-date regional operational insight. Study Performance Reporting & Escalation * Own weekly and ad-hoc alignment calls with sponsor and affiliate teams, reporting on site performance, activation status, enrollment progress, risks, and follow-up actions. * Maintain and present clear, accurate performance dashboards and status updates that enable sponsors to make timely decisions. * Escalate site-level risks and sponsor concerns to internal stakeholders early, driving resolution before they affect timelines or relationships. * Perform other tasks as assigned. What You Bring to the Team  * 8+ years of experience in clinical trial operations, sponsor-facing roles, or study management within pharma, biotech, a CRO, or a site network organization. * Proven track record of building and managing sponsor or CRO relationships in an operational capacity. * Deep understanding of clinical trial processes, site operations, and the sponsor-CRO-site dynamic across Central/Eastern Europe. * Experience leading study kickoffs and managing cross-functional stakeholder communication across complex, multi-country studies. * Excellent communication and presentation skills; comfortable engaging senior stakeholders at sponsor and CRO organizations. * Strong organizational skills with the ability to manage multiple sponsor relationships and studies simultaneously. * Ability to independently develop clear and structured presentations, RACI-charts and process flows. * Fluency in English and Polish required; Additional CEE languages strongly preferred. * Willingness to travel approximately 20% across the region for sponsor meetings and kickoff events. Preferred Qualifications *  Experience working within or alongside a site network organization. *  IBD, GI, hepatology, or obesity clinical trial experience. * Experience with Salesforce, Asana, or CRM/project management tools. * Familiarity with the EU-CTR regulatory environment and country-level affiliate structures in CEE. What Success Looks Like * Sponsors and local affiliates have a single, trusted IH counterpart in CEE they proactively engage throughout the study lifecycle. * Study kickoffs are structured, well-documented, and set clear expectations for all parties from day one. * IH's value proposition is current, credible, and consistently communicated to regional sponsor audiences. * Site performance, risks, and pull-through actions are reported accurately and acted on in weekly alignment cadences. * Sponsor satisfaction and retention improve measurably, and IH's share of new studies within existing sponsor relationships grows. * IH is recognized by regional sponsors as a preferred network partner in CEE. At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.