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, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’ scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. We were founded in 2014 and are headquartered in Boston, Massachusetts. For more information, visit www.compasstherapeutics.com.Our Executive team&nbsp;is seeking a hands-on Medical Director. The ideal candidate will have a track-record of successful drug development for early to late-stage antibody assets in oncology. This position reports onsite to our SVP of Clinical Development. Responsibilities: Monitor oncology-based clinical trials to keep on track to reach milestones within established timelines, identify and mitigate risks, and make necessary adjustments to study protocols Lead the medical activities including oversight of our Clinical Research Organization (CRO) counterpart, ensuring quality, patient safety, and compliance with GCP standards Oversee data management, safety, database review, regulatory compliance, etc. Execute successful clinical research activities according to the strategic plan to support product approval, including the management of internal and external stakeholders and partners Responsible for study start-up and site initiation, including site initiation visits (SIVs), in conjunction with Clinical Operations Collaborate cross-functionally and maintain productive relationships with the Clinical leadership, and key colleagues in the execution of clinical research activities, specifically Heads of Clinical Development, Clinical Operations, CMC, and Translational Research Develop and maintain strong external relationships, especially with KOLs and Study Investigators Evaluate clinical trial data required to determine potential efficacy, safety profile, etc. Utilize scientific/medical expertise and problem-solving skills to resolve study related issues as they arise Maintain a high level of clinical and scientific expertise in oncology by reviewing literature, attending scientific conferences, and through relationships with KOLs, investigators, potential partners, and internal stakeholders Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards Qualifications: MD with experience in oncology, immune-oncology, or relevant medical specialty area 5+ years’ life sciences industry experience, with strong oncology medical oversight experience Clinical drug development industry experience required, with significant knowledge and experience in the execution of clinical trials Deep knowledge and expertise in Oncology, and understanding of cross-functional teams Thorough understanding of applicable regulatory agency guidelines to ensure the appropriate conduct of clinical studies, oversee all activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct Exemplary written and verbal business communication skills, including executive presence Advanced working knowledge of FDA and all required regulatory guidelines Self-motivated, analytical, meticulous, flexible and eager to take on new tasks Ability to collaborate in a fast-paced team‐oriented environment, desire to mentor junior leaders and clinical employees is preferred Proficiency in utilizing Microsoft Office Suite &nbsp;At Compass, we provide employees with an inclusive offering of benefits and a competitive compensation package. We offer our employees competitive salaries, discretionary bonuses, and meaningful equity participation. Our innovative benefits support the health and wellness of our employees; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, an employee assistance program, life insurance, and much more. We also provide 401(k) and Roth 401(k) programs with a 6% company match, and other resources for financial wellness. Additional benefits include commuter reimbursement, subsidized company parking, cell phone reimbursement, Summer Fridays, and substantial paid time off including a winter shut down week. Our Mission at Compass is to develop next generation antibodies into transformative cancer therapies that improve patients’ lives. Our Compass Core Values guide us in achieving this. We are mission-focused and share a passion for science and creativity that help us innovate in all that we do. Our unique community promotes authenticity, diversity of thought, and collaborative teamwork. &nbsp; We invest in the growth and development of our teams and individuals through programs such as company-wide trainings, cross-functional collaboration and job shadowing, tuition reimbursement, employee recognition awards, and a comprehensive performance management cycle. Also, our Compass Culture Committee empowers employee-organized events that celebrate wins, drive initiatives, support local philanthropy, and align with our mission and values.

Medical Director

Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’ scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. We were founded in 2014 and are headquartered in Boston, Massachusetts. For more information, visit www.compasstherapeutics.com.We are seeking an experienced and driven Director of Analytical Development, reporting to our VP &amp; Head of CMC. This position will lead analytical development activities and implementation of analytical strategies for our clinical-stage antibody assets. The ideal candidate will have a strong background in analytical methods development, validation, and technology transfer. This position reports onsite a minimum of 4 days/week to our office in Boston, MA. Responsibilities: Oversee and manage analytical development processes across all three of our clinical-stage antibody assets / drug candidates in support of commercialization Lead authoring of CMC analytical dossier and relevant sections of regulatory filings for regulatory submissions (IND, IMPD, PAS, BLA, etc.), address queries from health authorities, engage in face-to-face FDA inspection, Type-C meetings Develop and lead phase-appropriate analytical control strategy including establishment of quality target product profile (QTPP), assessment of critical quality attributes (CQAs), justification of specifications and establishment of test methods for antibody programs Accountable for method development and qualification in support of process development, product release and stability, product characterization, investigation, and process performance qualification; including improving drug substance and drug product technology transfer Design and oversee extended characterization studies of drug substances, drug products, and associated impurities, direct comparability strategies including assessments and stability programs Oversee analytical technical activities at CMO/CDMOs and contract laboratories during the process development, analytical method development, clinical batch testing, stability testing and CMC compilation of assigned projects Supervise product QC batch release testing of GMP drug substance and drug product lots and ensure compliance with relevant regulatory guidelines and standards Oversee nonGMP/GMP stability programs for all clinical-stage assets, following ICH stability requirements for setting shelf life/expiry Collaborate cross-functionally with internal and external teams to ensure alignment in development of processes, guidelines, strategies and timelines for analytical development Actively engage with leaders across the organization to drive the improvement of analytical approaches in experiment design, data analysis, documentation and reporting Expertly present to C-suite leadership, providing critical insights and recommendations to support company decisions Qualifications: PhD with 5+ years of relevant experience, or 10+ years of experience with a Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field; equivalent advanced degrees considered Expert working knowledge with late-stage regulatory requirements and regulations governing the US and globally (FDA, ICH, etc.) pertaining to analytical development, including IND- and BLA-enabling regulatory writing Proven relevant experience in analytical development for antibody therapies (monoclonal and/or bispecific) within the biopharmaceutical/biotech industry is required Expertise in leading CMC projects, developing and validating analytical methods for antibodies/bispecific antibodies per ICH and regulatory guidelines Proven track record of successful technology transfers Strong knowledge of the overall biologics development and commercialization process with a proven record of applying CMC to BLA authoring to ensure execute analytical strategies approvable by health agencies Experience working with statistical techniques for data analysis and reporting, strong analytical skills to synthesize and analyze data effectively from various sources Ability to apply principles of Analytical Quality by design, including development of critical quality attributes, phase-appropriate method validation strategies, and development of an analytical control strategy in support of PPQ validation Working knowledge of analytical characterization techniques for biopharmaceuticals is highly desirable Experience maintaining effective relationships with internal and external stakeholders, including collaborations with external partners Demonstrated success in problem solving, task management, and effective communication in a fast-paced collaborative work environment Comfortable working independently and completing multiple complex project objectives simultaneously Experience in recruiting and leading junior analytical scientists supporting outsourced CMC programs including method development, qualification, and validation activities Self-motivated, organized, meticulous, flexible and eager to take on new tasks At Compass, we provide employees with an inclusive offering of benefits and a competitive compensation package. We offer our employees competitive salaries, discretionary bonuses, and meaningful equity participation. Our innovative benefits support the health and wellness of our employees; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, an employee assistance program, life insurance, and much more. We also provide 401(k) and Roth 401(k) programs with a 6% company match, and other resources for financial wellness. Additional benefits include commuter reimbursement, subsidized company parking, cell phone reimbursement, Summer Fridays, and substantial paid time off including a winter shut down week. Our Mission at Compass is to develop next generation antibodies into transformative cancer therapies that improve patients’ lives. Our Compass Core Values guide us in achieving this. We are mission-focused and share a passion for science and creativity that help us innovate in all that we do. Our unique community promotes authenticity, diversity of thought, and collaborative teamwork. &nbsp; We invest in the growth and development of our teams and individuals through programs such as company-wide trainings, cross-functional collaboration and job shadowing, tuition reimbursement, employee recognition awards, and a comprehensive performance management cycle. Also, our Compass Culture Committee empowers employee-organized events that celebrate wins, drive initiatives, support local philanthropy, and align with our mission and values.

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