Jobs at Compass Therapeutics Inc. (Now Hiring) — 2 open

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 that span all phases of studies and include 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 www.compasstherapeutics.com.

Position Overview:

Our Medical team is seeking a hands-on Medical Director reporting directly to our Chief Medical Officer. The Medical Director will own and lead a variety of key medical and clinical initiatives, as well as collaborating with functions throughout the organization. The ideal candidate will have deep medical experience and a track-record of successful drug development for early to late clinical-stage oncology assets, ideally spanning multiple indications and modalities, including antibodies.

This position is on-site at our office in Brighton, MA with an expectation of 4 days/week in the office.

Responsibilities:

• Ensure that Compass corporate and Medical goals are on track to reach milestones within established timelines, while delivering within applicable quality and regulatory standards
• Execute successful clinical research activities according to the strategic plan to support product approval, including the management of internal and external stakeholders and partners
• Lead our relationships with various Clinical Research Organizations (CRO) and other key clinical vendors, ensuring quality, patient safety, and compliance with GCP standards
• Monitor oncology-based clinical trials to achieve milestones within established timelines, identify and mitigate risks, and make necessary adjustments to study protocols
• Oversee data management, safety, database review and medical cleaning, regulatory compliance, and related activities
• Partner with Clinical Operations on study start-up and site initiation, including site initiation visits (SIVs)
• Collaborate cross-functionally and maintain productive relationships with the Executive Leadership Team, Clinical leadership, and key colleagues in the execution of clinical research activities, specifically Heads of 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, and other key clinical indicators
• 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 and other relevant tools