VP of Regulatory Affairs

2 weeks ago

Boston, United States Compass Therapeutics Full time
Job DescriptionJob 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 leadership team is seeking a highly motivated and experienced VP of Regulatory Affairs. The ideal candidate will have a proven track-record of leading successful BLA submissions and desires to be part of a results-oriented, fast-paced, and collaborative team. This position reports to our CEO and is fully onsite in our Boston, MA office.

Responsibilities:

  • As an Executive leader, this role will be pivotal in shaping the company's trajectory by driving the regulatory function and providing expert strategic insights and solutions toward successful product approvals.
  • Lead the Regulatory function, build regulatory strategy and provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards.
  • Deliver successful submissions/filings and outcomes with health authorities by providing effective leadership, oversight, direction, and planning.
  • For each Clinical Program, develop timelines, milestones, and budgets in order to track progress, identify risks/constraints, and propose management effective solutions in a timely manner.
  • Prepare and contribute to reports and regulatory submissions, including identification and mitigation of potential critical issues, regulatory risks, to support decision-making on our product candidates.
  • Coordinate briefing book roundtables, draft regulatory notifications, manage regulatory document workflows, organize information into regulatory information management systems.
  • Partner with the Clinical team and the CMC team as well as external Regulatory and QA consultants to ensure regulatory plans are well established and maintained and leads to the seamless execution of the company goals.
  • Ensure outsourced Regulatory deliverables meet all program timelines and company standards.
  • Recommend and implement SOPs and tools to aid in Regulatory success.
  • Proactively meet with senior executives to drive decision making processes and escalate issues to achieve regulatory milestones, through both scheduled and ad-hoc updates.
  • Build and maintain effective relationships with internal and external stakeholders including vendors, partners, CROs, the President of R&D, team members in Translational, CMC, and Clinical to drive regulatory strategy to successful FDA interaction.
  • Mentor teams and provide training on Regulatory and program deliverables and expectations.

Qualifications:

  • Advanced degree in life/health sciences or healthcare related field with 12+ years of relevant life science industry experience, or a PhD or MD with 8+ years of industry experience; Bachelor's degree or equivalent with 15+ years of relevant experience considered.
  • 5+ years in an executive role in life sciences working closely with senior executives is
  • Proven experience working with the FDA leading major Regulatory submissions for oncology indications; having led successful BLA and CTA fillings is preferred.
  • Demonstrated deep understanding of the US Regulatory frameworks is essential.
  • Ability to effectively liaise cross-functions with internal/external stakeholders, partners, vendors.
  • Ability to prepare executive-level presentations from data analytics and metrics, to inform decisions and optimize project outcomes.
  • Adept at incorporating diverse input and feedback from several stakeholders to identify potential challenges and drive effective solutions, ensuring decisions are properly implemented.
  • Proven ability to work effectively internally and externally, and to manage external consultants.
  • Solution-oriented with strong interpersonal, organizational, and creative problem-solving
  • Comfortable with balancing multiple project objectives simultaneously within assigned timelines.
  • Ability to push timelines and motivate teams toward company goals across functions in a diverse, collaborative team.
  • Excellent written and verbal business communication
  • Advanced working knowledge of the US Regulatory landscape including regulatory, compliance, and quality guidelines, specifically for oncology clinical drug development.
  • Comprehensive knowledge of the life sciences industry, oncology drug development and management and regulatory requirements.

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.

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