Executive Director Safety Physician

Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.

We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.

Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.

Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.

As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.

Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.

Summary:

We seek a highly skilled and experienced Safety Physician to lead and oversee safety-related aspects of Cullinan clinical trials. The ideal candidate will have a deep understanding of medical safety, risk management, and regulatory compliance, primarily in oncology therapeutic areas. This role involves providing strategic leadership, ensuring patient safety, and collaborating cross-functionally with various teams.

• Be the Guardian of Safety: Provide expert leadership and oversight for all clinical trial safety aspects, establishing best practices and ensuring regulatory compliance.
• Lead Your Team: Build and manage a high-performing safety team, guiding and empowering them to excel in their roles.
• Proactive Risk Management: Develop and implement comprehensive safety strategies to minimize risks and prioritize patient well-being.
• Collaborative Excellence: Partner with clinical development, regulatory, quality assurance, and other teams to ensure seamless integration of safety considerations.
• Data-Driven Decisions: Lead the review and analysis of safety data, ensuring accurate reporting and timely response to adverse events.
• Regulatory Expertise: Navigate the complexities of global safety regulations and provide clear guidance to the team.
• Documentary Mastery: Author, review, and provide expertise for protocols, IBs, SAPs, DSURs, CSRs, and other crucial documents.
• External Collaboration: Build strong relationships with regulators and other external stakeholders, confidently representing our pharmacovigilance function.

• Board-certified physician (or equivalent) with 8+ years of biopharma experience in clinical research safety, primarily in the oncology space.
• Demonstrated success in leading and managing safety teams and ensuring clinical trial safety.
• Deep understanding of global regulatory requirements for clinical trial safety reporting.
• Proven expertise in pharmacovigilance, risk management, and regulatory compliance.
• Sharp analytical and problem-solving skills.
• A collaborative team player with excellent communication and interpersonal skills.
• Critical thinker and decisive decision-maker.

Cullinan Oncology is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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