Description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

SystImmune is seeking an experienced Director/Senior Director of Clinical Development to lead the direction, planning, execution, and interpretation of clinical trials within the Clinical Development program. This person would also collaborate across functions to deliver high-quality clinical data that supports product development, regulatory submissions, and business strategy.

Key Responsibilities

Lead the design and implementation of clinical development programs grounded in sound medical and scientific principles, regulatory knowledge, and business objectives. Provide strategic medical input across the product lifecycle from early development through phase 3, for both internal and partnered programs.
Oversee the execution and integrity of clinical trials. Collaborate with Clinical Operations to manage enrollment progress, timeline adherence, and delivery of key milestones. Proactively monitor trial safety in coordination with the Safety team, ensuring compliance with serious adverse event (SAE) reporting requirements.
Drive the development and scientific accuracy of key clinical documents, including protocols, Investigator Brochures, Clinical Study Reports (CSRs), regulatory submissions, and response packages.
Serve as the medical lead on clinical study teams , aligning medical strategy across functions. Act as a key clinical representative in regulatory interactions and ensure adherence to GCP, pharmacovigilance standards, SOPs, and global compliance requirements.
Provide in-house clinical expertise on assigned compounds and indications. Actively engage with investigators and opinion leaders to inform development strategy and protocol design. Stay current on therapeutic area developments through continuous learning and participation in scientific forums

Qualifications

Director/Senior Director, Clinical Development

Description

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