Job Description
Job Description
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 Executiveteamis 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
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.
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.