Senior Director - Regulatory Affairs

February 7

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Adaptive Biotechnologies Corp.

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Adaptive Biotechnologies Corp. is a leader in immune-driven medicine, aiming to revolutionize disease detection and treatment. By utilizing the adaptive immune system, the company develops diagnostic and therapeutic solutions powered by its innovative Immune Medicine platform. They offer clinical diagnostics, particularly in Minimal Residual Disease (MRD) testing, and engage in drug discovery and therapeutic development through adaptive immunosequencing technologies. Their biopharma services support the progression of clinical trials and the development of transformative medicines. Adaptive Biotechnologies leverages the complex biology of the immune system, decoding it to advance medical science and improve patient outcomes.

Biotechnology • Research • Diagnostic • Therapeutics

501 - 1000 employees

Founded 2009

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $125M Post-IPO Debt on 2022-09

📋 Description

• At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated. • As an Adapter, you’ll have the opportunity to make a difference in people’s lives. • Adaptive is searching for a Senior Director, Regulatory Affairs to function as a key leader within our Measurable Residual Disease (MRD) business. • This includes developing, leading, and driving the execution of the global regulatory strategy for Adaptive’s diagnostics business. • This position will operate as a 'player-coach' - directing the activities of the Regulatory team while owning strategic planning, meeting preparation, agency negotiation, and final submissions of all regulatory affairs. • Reporting directly to the Chief Commercial Officer of our MRD Business Unit, you will manage a team of direct reports and work collaboratively with various leadership teams to accomplish Adaptive’s regulatory and corporate objectives. • Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. • Critical functions include helping establish individual team member goals, aligning those goals with broader objectives, and ensuring the achievement of company goals. • Providing coaching and feedback to team members will drive performance excellence and accountability, as well as support growth and development. • Leaders create an environment of belonging, respect, and open and honest communication.

🎯 Requirements

• BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree strongly preferred. • 17+ years (14+ with MS, or 10+ with PhD) of progressive management experience in global regulatory affairs in a diagnostic, medical device or life sciences technology-driven company. • In vitro diagnostics (IVD) experience required. • Experience with diagnostic product regulatory submissions in relevant therapeutic areas (hematology, oncology, immunology); experience with next-generation sequencing or similar high complexity diagnostic products highly preferred. • Experience in strategic planning and collaboration with executives, key operational groups and external partners. • Expertise with all phases of the product development lifecycle, including feasibility, design, development, transfer, verification and validation activities necessary for research and diagnostic product commercialization. • Extensive experience in ISO, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements. • Proven hands-on experience in submission and approval of US regulatory filings and reporting including US PMA, de novo, IDE, and 510(k) filings; cDx experience highly preferred • Relationships with and ability to personally engage current CDRH leadership highly preferred • Knowledge of and direct experience with market entry strategies, regulatory pathways and approval process in other key countries/regions globally (e.g., Canada, major European markets, Japan, Australia, China) • History of successful direct interactions and negotiations with regulatory agencies. • Experience directly implementing or partnering with Quality leadership to implement and managing quality/compliance systems and ensuring inspection readiness in alignment with requirements of global regulatory authorities.

🏖️ Benefits

• equity grant • bonus eligible