Compass Therapeutics is a biotechnology company focused on developing antibody therapeutics to treat cancer and autoimmune diseases. The company's innovative approach harnesses the power of the immune system to target specific disease pathways, offering promising new treatment options for patients in need. With a dedication to advancing precision medicine and improving patient outcomes, Compass Therapeutics is at the forefront of cutting-edge research and development in the field of biopharmaceuticals.

compass-therapeutics

<p>Compass Therapeutics, Inc. was founded in 2014 and is headquartered in Boston, MA. We are an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics to treat multiple diseases. Our robust pipeline currently includes four clinical assets spanning all phases of development, with novel mechanisms of action, and first-in-class or best-in-class potential across multiple tumor types. Our lead clinical-stage asset, tovecimig, has completed a randomized late-stage biliary tract cancer study and we are preparing for a BLA submission. We are now at an exciting inflection point as we build out a commercial organization to support our first product launch. This is a unique and pivotal moment to join us and help make a meaningful impact on patients’ lives. For more information, visit <a href="http://www.compasstherapeutics.com">www.compasstherapeutics.com</a>.</p>
<p>Our Biometrics team is seeking a highly motivated and hands-on Clinical Data Manager II to support our oncology clinical programs. The ideal candidate will have demonstrated experience overseeing CROs, managing and validating external data, and ensuring high-quality clinical trial data from study start-up through database lock. This individual will thrive in a fast-paced, collaborative environment and will report to the Director of Biometrics.</p>
<p>This position reports onsite 4 days/week in our office in Brighton, MA.</p>
<p><strong>Responsibilities:</strong></p>
<ul>
<li>Ensure that Compass Clinical and Data Management goals are on track to reach milestones within timelines, while adhering to project and study team expectations regarding quality, time and cost, and applicable regulations</li>
<li>Serve as the primary contact overseeing data management across multiple CRO partners and other external vendors across relevant clinical programs, including managing expectations, deliverables, data workflows, quality, issue resolution, and compliance with protocols, internal procedures, GCP, applicable regulatory guidelines, company policies, and SOPs</li>
<li>Establish data transfer guidelines and agreements with CROs and external data vendors; oversee the receipt, integration, validation, reconciliation, review, and transfer of external clinical data in accordance with study timelines and requirements</li>
<li>Provide a high level of expertise and guidance in data management to support clinical studies</li>
<li>Lead the establishment and optimization of Clinical Data Management (CDM) processes, including identifying, authoring, reviewing, implementing, and maintaining SOPs and Work Instructions to ensure compliance with regulatory requirements, GCP, and ICH guidelines; support cross-functional process definition, innovation, and continuous improvement of clinical data management activities</li>
<li>Lead and oversee the design and creation of clinical trial study databases and perform Sponsor User Acceptance Testing (UAT) activities for database builds and subsequent database modifications</li>
<li>Provide strategic data management expertise and guidance to clinical project/study teams to optimize study-specific clinical trial processes and ensure high-quality, timely, and cost-effective delivery</li>
<li>Collaborate with cross-functional partners to develop project and study timelines and maintain internal data management timelines, ensuring deliverables meet quality expectations</li>
<li>Review and contribute to clinical study-related documents from a data management perspective (e.g., protocol) and approve DM-specific documents (e.g., Data Management Plan, Data Review Plan, CRF Completion Guidelines, etc.)</li>
<li>Coordinate with Pharmacovigilance on adverse events (AE/SAE) reconciliation and work with medical coding (MedDRA, WHO Drug Global) to ensure coding is performed according to study timelines</li>
<li>Lead the internal data review process in collaboration with study teams to ensure data quality</li>
<li>Define the data listings needed to support the data review and ensure all identified issues are documented appropriately and resolved</li>
<li>Ensure archival and inspection readiness of all Data Management Trial Master (TMF) documents</li>
<li>Provide comprehensive data management expertise to project and study teams and train other personnel on data management-related activities, including eCRF and EDC system (iMedidata)</li>
<li>Work with medical coding (MedDRA, WHO Drug Global) to ensure coding is performed within the specified study timeline</li>
<li>Participate in audits and inspections, and assist in performing functional assessments of data management CROs/vendors</li>
<li>Promote standardization, automation, process improvement and technical enhancement in CDM to improve efficiency and data quality</li>
</ul>
<p><strong>Qualifications:</strong></p>
<ul>
<li>Bachelor’s or Advanced degree in life sciences, healthcare, or a related field, or a combination of education and relevant experience; clinical research experience or education is a plus</li>
<li>5+ years of progressive clinical data management experience within the pharmaceutical or biotechnology industry; experience in a small biotechnology company or similarly fast-paced, resource-limited environment is strongly preferred</li>
<li>Proving working knowledge of CDISC standards and hands-on experience reviewing or supporting SDTM mapping and related data-transformation activities</li>
<li>Experience with EDC database development, edit-check specifications, sponsor UAT, database modifications, and database-lock activities</li>
<li>Advanced phase experience is preferred; experience supporting Phase 2 or later-stage clinical trials is preferred</li>
<li>Strong hands-on experience overseeing data management CROs and external data vendors, including deliverable management, quality oversight, issue resolution, and managing timelines</li>
<li>Demonstrated ability to independently manage 2+ clinical programs with minimal supervision in a fast-paced environment</li>
<li>Hands-on experience with clinical data review, including the identification, tracking, and resolution of data-quality issues</li>
<li>Strong organizational, analytical, problem-solving, and cross-functional communication skills</li>
<li>Experience managing local and central laboratory data, including data transfer specifications, data review, reconciliation, and issue resolution</li>
<li>Oncology clinical trial experience is strongly preferred, including the review and management of tumor assessment and RECIST data</li>
<li>Medical coding and safety reconciliation experience is preferred, including MedDRA, WHO Drug Global, and SAE reconciliation</li>
</ul>
<p>&nbsp;</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Base Salary Range in Job Post</div><div class="pay-range"><span>$130,000</span><span class="divider">&mdash;</span><span>$170,000 USD</span></div></div></div><div class="content-conclusion"><p>Our mission is to bring transformative oncology therapies to patients. We built our core values from the employees up and each and every one of us is essential to achieving our mission. We are <strong>mission-focused, </strong>share a <strong>passion for science </strong>and <strong>creativity</strong> that help us innovate in all that we do. Our unique culture and <strong>community </strong>promotes authenticity, diversity of thought, and collaborative <strong>teamwork</strong>. &nbsp;</p>
<p>Compass provides employees with a comprehensive and market-leading compensation and benefits package. Our compensation package includes a base salary, discretionary bonus, and meaningful equity participation for every employee. Our innovative benefits offerings support holistic employee health and wellness - from subsidized medical, dental and vision premiums to health reimbursement arrangement, flexible spending accounts, gym membership, employee assistance program, life insurance, and much more. We also offer 401(k) and Roth 401(k) programs with a 6% company match. Additional benefits include company parking, commuter reimbursement, and substantial vacation and leave policies, including summer Fridays, and a winter shut down week.</p>
<p>Beyond traditional benefits, we invest in the growth and development of our teams and individuals through programs such as company-wide training, tuition and training reimbursement, recognition awards, and comprehensive performance management. With our Compass Culture Committee, we grow and preserve our culture through: events that build camaraderie and celebrate wins both large and small, diverse employee-driven initiatives, participation in charitable causes, and other programs that align with our values.</p></div>

Clinical Data Manager II

<p>Compass Therapeutics, Inc. was founded in 2014 and is headquartered in Boston, MA. We are an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics to treat multiple diseases. Our robust pipeline currently includes four clinical assets spanning all phases of development, with novel mechanisms of action, and first-in-class or best-in-class potential across multiple tumor types. Our lead clinical-stage asset, tovecimig, has completed a randomized late-stage biliary tract cancer study and we are preparing for a BLA submission. We are now at an exciting inflection point as we build out a commercial organization to support our first product launch. This is a unique and pivotal moment to join us and help make a meaningful impact on patients’ lives. For more information, visit <a href="http://www.compasstherapeutics.com">www.compasstherapeutics.com</a>.</p>
<p>Our Clinical Development team<em>&nbsp;</em>is seeking a highly motivated Associate Director/Director of Pharmacovigilance (PV) Operations. The ideal candidate will have a proven track-record of PV operations, including experience supporting the transition from clinical to commercial stage, and will be a hands-on leader who thrives in a fast paced and collaborative environment.</p>
<p>This position reports to our VP of Drug Safety and Pharmacovigilance (DSPV) and is onsite 4 days/week in our office in Brighton, MA.</p>
<p><strong>Responsibilities:</strong></p>
<ul>
<li>Ensure Compass Pharmacovigilance (PV) objectives are achieved in alignment with timelines, quality standards, applicable regulations, and commercial readiness requirements</li>
<li>Strategically lead the scale-up of Compass’ global PV operations infrastructure as the company transitions from a clinical-stage development pipeline to a commercial-stage company</li>
<li>Manage scaling of PV operations, systems and processes, safety and vendor governance, risk management, internal and external partnerships, audit and inspection readiness, for commercial readiness in support of compliant regulatory filings and commercial launch; as detailed below</li>
<li>Lead the design, implementation, and ongoing maintenance of the post-market PV system and associated Quality System to support upcoming marketing authorizations (NDA/MAA) and commercial readiness</li>
<li>Support the VP of Pharmacovigilance in safety evaluation, benefit-risk assessment, and compliance activities by providing pharmacovigilance operations expertise</li>
<li>Serve as the company’s pharmacovigilance operations expert, maintaining current knowledge of drug safety requirements and identifying risks, gaps, and opportunities for improvement</li>
<li>Establish the PV operational governance framework, and optimize existing PV systems, processes, oversight of PV vendors, and infrastructure to support commercial readiness and scalable post-marketing commercial and medical strategies</li>
<li>Serve as a core contributor to marketing authorization applications (NDA/MAA), co-authoring or reviewing clinical safety summaries, Risk Management Plans (RMPs), and Pharmacovigilance System Master File (PSMF), and other required safety documentation</li>
<li>Author, enforce, and continuously improve internal PV policies, SOPs, charters, templates, forms, training materials, and meet global commercial Good Pharmacovigilance Practices (GVP)</li>
<li>Draft and maintain Safety Data Exchange Agreements (SDEAs), safety product/project plans, quality processes, and related PV procedures, ensuring compliance by providing training</li>
<li>Draft and negotiate SDEAs with global licensing partners and commercial distributors to establish clear responsibilities and timelines, to ensure safety data synchronization</li>
<li>Optimize safety databases by directing the configuration, validation, and overseeing ongoing use of databases (e.g., Argus, ARISg) to accommodate commercial data volumes and requirements</li>
<li>Oversee PV operational support for active Phase I–III clinical trials, including safety management plan (SMP) execution, SAE reconciliation, case processing, and coordination with internal and external service providers</li>
<li>Lead the selection, qualification, contract negotiation, governance, and performance oversight of external PV vendors and CROs, including transition of vendor scopes from clinical-only to commercial case processing, escalating significant issues to the VP of Drug Safety/PV</li>
<li>Establish and monitor rigorous metrics-based PV Key Performance Indicators (KPIs) to assess vendor performance, quality, regulatory compliance, timeliness, and data integrity ensuring high-quality case management, inspection readiness, and delivery of contracted services</li>
<li>Collaborate with internal and external stakeholders to bridge clinical trial safety workflows with commercial case-management realities and manage scaling vendor networks</li>
<li>Comply with PV regulatory timelines and meet corporate inspection readiness expectations</li>
<li>Serve as the operational lead for pre-approval and post-approval regulatory inspections (FDA, EMA), coordinating preparation, responses, and follow-up activities for the PV function</li>
<li>Oversee internal and external PV audits and investigations into late cases, deviations, or non-compliance, including implementation of robust Corrective and Preventive Action (CAPA) plans</li>
<li>Partner cross-functionally with Clinical Development, Quality, Regulatory Affairs, Medical Affairs, Quality, and external vendors to integrate PV requirements and safety governance throughout drug development and corporate strategy</li>
<li>Lead interactions with Safety Review Committees and provide input on IDMCs and other safety governance bodies</li>
</ul>
<p><strong>Qualifications:</strong></p>
<ul>
<li>Bachelor’s degree in nursing (BSN), pharmacy, or a related healthcare/life science field required, Master’s degree in nursing (MSN) or an advanced degree preferred</li>
<li>8+ years of progressive clinical drug safety/pharmacovigilance experience in the biotech or pharmaceutical industry is required; small company experiences preferred</li>
<li>Director-level candidates require 12+ years of experience, including positions of leadership</li>
<li>Experience working within a company transitioning from clinical to commercial stage, or direct experience launching a new commercial pharmaceutical asset</li>
<li>3+ years of vendor oversight experience overseeing pharmacovigilance vendor performance</li>
<li>Oncology experience preferred</li>
<li>Deep expertise with and experience following regulations and guidelines for such as FDA, EMA, ICH, and global GVP regulations, including direct experience defending systems during regulatory agency inspections</li>
<li>Expert-level knowledge working within global safety databases (Argus/ArisG) and clinical Electronic Data Capture (EDC) systems (Medidata Rave/InForm)</li>
<li>Demonstrated proficiency working with and improving processes within a global Drug Safety Database required, as well as other relevant programs such as Microsoft Office Suite</li>
<li>Expertise in pre- and post-approval PV/safety risk management process and procedures</li>
<li>Thorough understanding of the drug development process and context applicable to safety surveillance activities, i.e. signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials</li>
<li>Strong analytical ability to synthesize and analyze safety data effectively from various sources</li>
<li>Proven experience working within a cross-functional team environment, ability to work in a fast-paced and collaborative environment, balancing multiple project objectives simultaneously</li>
<li>Ability to assimilate clinical data and through comprehensive analysis/review and assessments</li>
<li>Strong written, verbal, technical communication and presentation skills</li>
</ul>
<p>&nbsp;</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Base Salary Range in Job Post</div><div class="pay-range"><span>$175,000</span><span class="divider">&mdash;</span><span>$250,000 USD</span></div></div></div><div class="content-conclusion"><p>Our mission is to develop next generation antibodies into transformative cancer therapies that improve patients’ lives. We built our core values from the employees up and each and every one of us is essential to achieving our mission. We are <strong>mission-focused, </strong>share a <strong>passion for science </strong>and <strong>creativity</strong> that help us innovate in all that we do. Our unique culture and <strong>community </strong>promotes authenticity, diversity of thought, and collaborative <strong>teamwork</strong>. &nbsp;</p>
<p>Compass provides employees with a comprehensive and market-leading compensation and benefits package. Our compensation package includes a base salary, discretionary bonus, and meaningful equity participation for every employee. Our innovative benefits offerings support holistic employee health and wellness - from subsidized medical, dental and vision premiums to health reimbursement arrangement, flexible spending accounts, gym membership, employee assistance program, life insurance, and much more. We also offer 401(k) and Roth 401(k) programs with a 6% company match. Additional benefits include company parking, commuter reimbursement, and substantial vacation and leave policies, including summer Fridays, and a winter shut down week.</p>
<p>Beyond traditional benefits, we invest in the growth and development of our teams and individuals through programs such as company-wide training, tuition and training reimbursement, recognition awards, and comprehensive performance management. With our Compass Culture Committee, we grow and preserve our culture through: events that build camaraderie and celebrate wins both large and small, diverse employee-driven initiatives, participation in charitable causes, and other programs that align with our values.</p></div>

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