Apogee Therapeutics

Associate Director, Biomarker Development

Apogee Therapeutics · Full Time · 5 days ago

Apogee Therapeutics

🌎 United States 💵 $190K - $210K per year ⭐ 10+ yrs exp 💼 Others

Lead the development and execution of biomarker strategies for clinical programs in inflammatory and immune indications. Collaborate across functions to design assays, manage CROs, and analyze biomarker data for regulatory documents and scientific publications.

APPLY

Director, AI Enablement

Apogee Therapeutics · Full Time · 15 days ago

Apogee Therapeutics

🌎 United States 💵 $225K - $250K per year ⭐ 10+ yrs exp 💼 Software Development

The Director will shape and execute the enterprise AI strategy, overseeing the adoption, governance, and measurement of AI tools across the organization. They will lead the AI Enablement Program, managing the use case pipeline and collaborating with Cybersecurity, Legal, and Clinical teams to ensure compliant deployment.

APPLY

Director, IT Quality & Compliance

Apogee Therapeutics · Full Time · 15 days ago

Apogee Therapeutics

🌎 United States 💵 $220K - $245K per year ⭐ 10+ yrs exp 💼 Legal

Serve as the primary IT business partner for the Quality organization and own the company's IT compliance and validation functions. Responsibilities include managing Veeva Vault Quality, authoring CSV scripts, and driving IT inspection readiness.

APPLY

Senior Manager, Medical Writing

Apogee Therapeutics · Full Time · a month ago

Apogee Therapeutics

🌎 United States 💵 $160K - $180K per year ⭐ 10+ yrs exp 💼 Healthcare

The role involves preparing and editing high-quality regulatory documents such as protocols, clinical study reports, and briefing documents. The manager will also oversee external vendors and implement AI-enabled tools to enhance writing efficiency and quality.

APPLY

Director, GMP Quality Assurance

Apogee Therapeutics · Full Time · a month ago

Apogee Therapeutics

🌎 United States 💵 $210K - $235K per year ⭐ 10+ yrs exp 💼 Software Development

The Director of GMP Quality Assurance will oversee the quality, safety, and compliance of biologics manufacturing processes and device development activities. They will manage quality systems, perform audits, and partner with Technical Operations to ensure adherence to GMP regulations.

APPLY

Senior Manager, Regulatory Affairs

Apogee Therapeutics · Full Time · a month ago

Apogee Therapeutics

🌎 United States 💵 $155K - $175K per year ⭐ 5-10 yrs exp 💼 Legal

The Senior Manager will lead and coordinate regulatory strategies and submissions to the FDA and international health authorities. They will serve as the primary interface for regulatory publishing and support clinical study teams to ensure compliance and timely deliverables.

APPLY

Senior Manager, Clinical Biomarker Operations

Apogee Therapeutics · Full Time · a month ago

Apogee Therapeutics

🌎 United States 💵 $150K - $170K per year ⭐ 5-10 yrs exp 💼 Healthcare

The Senior Manager will plan and manage clinical biomarker sample logistics, including collection, testing, and data delivery across clinical trials. They will also oversee vendor performance, manage contracts and budgets, and ensure compliance with study protocols and quality standards.

APPLY

Senior Manager, Clinical Systems

Apogee Therapeutics · Full Time · a month ago

Apogee Therapeutics

🌎 United States 💵 $150K - $165K per year ⭐ 10+ yrs exp 💼 Healthcare

The Senior Manager of Clinical Systems serves as the technical lead for clinical technology initiatives, overseeing end-to-end system processes from startup through archival. This role involves managing cross-functional projects, ensuring regulatory compliance, and collaborating with IT and external vendors to optimize system performance.

APPLY

Executive Director, GMP Quality Assurance

Apogee Therapeutics · Full Time · 2 months ago

Apogee Therapeutics

🌎 United States 💵 $275K - $305K per year ⭐ 10+ yrs exp 💼 Software Development

The Executive Director will lead the global GMP Quality Assurance strategy to support the company's transition from clinical development to commercial operations. They are responsible for building a high-performing team, ensuring regulatory compliance, and overseeing quality systems across internal operations and external manufacturing partners.

APPLY

Associate Director, Clinical Operations Standards and Planning

Apogee Therapeutics · Full Time · 2 months ago

Apogee Therapeutics

🌎 United States 💵 $175K - $195K per year ⭐ 10+ yrs exp 💼 Healthcare

This role is responsible for identifying, documenting, and optimizing clinical operations standards and best practices to support a global portfolio of clinical trials. Additionally, the position oversees resource planning and management to ensure operational efficiency and inspection readiness across the organization.

APPLY

Clinical Trial Manager

Apogee Therapeutics · Full Time · 2 months ago

Apogee Therapeutics

🌎 United States 💵 $145K - $160K per year ⭐ 5-10 yrs exp 💼 Healthcare

The Clinical Trial Manager is responsible for the operational management and execution of global clinical trials, ensuring adherence to GCP and regulatory guidelines. They will oversee CROs and vendors, manage study budgets and timelines, and ensure high-quality data for regulatory submissions.

APPLY

Associate Director, Clinical Supply Chain Management

Apogee Therapeutics · Full Time · 2 months ago

Apogee Therapeutics

🌎 United States 💵 $170K - $190K per year ⭐ 10+ yrs exp 💼 Healthcare

Manage the end-to-end clinical supply chain for multiple clinical programs, ensuring timely delivery of investigational products and ancillary supplies. Collaborate with cross-functional teams and external partners to oversee supply planning, inventory, distribution, and regulatory compliance.

APPLY

Regional Director, Field Medical Affairs - East

Apogee Therapeutics · Full Time · 2 months ago

Apogee Therapeutics

🌎 United States 💵 $250K - $280K per year ⭐ 10+ yrs exp 💼 Healthcare

Lead and expand the Medical Science Liaison (MSL) team in the East region, focusing on coaching, development, and strategic direction. Ensure MSLs are equipped to engage with healthcare professionals and support clinical trials and corporate strategy.

APPLY

Senior Manager, Regulatory Affairs Project Management

Apogee Therapeutics · Full Time · 3 months ago

Apogee Therapeutics

🌎 Worldwide 💵 $150K - $170K per year ⭐ 5-10 yrs exp 💼 Product

This role involves optimizing the planning, execution, and tracking of development-stage global regulatory activities, driving global submission planning and coordination across multiple regions in alignment with development objectives. Key tasks include tracking timelines for submissions like IND/CTA/BLA/NDA/MAA, supporting strategic planning, and enhancing project management tools like Smartsheet.

APPLY

Senior Director, Commercial Strategy

Apogee Therapeutics · Full Time · 3 months ago

Apogee Therapeutics

🌎 Worldwide 💵 $255K - $285K per year ⭐ 10+ yrs exp 💼 Others

This role is responsible for supporting the ongoing planning and execution of the Company’s five-year U.S. commercial roadmap across various initiatives and building and executing a Commercial competitive intelligence process. Key duties include developing the commercial strategy for the lead asset, overseeing the 5-year commercialization roadmap execution, and partnering on the commercial operating model implementation.

APPLY

Director, Drug Product Development

Apogee Therapeutics · Full Time · 5 months ago

Apogee Therapeutics

🌎 Worldwide 💵 $210K - $235K per year ⭐ 10+ yrs exp 💼 Product

The Director of Drug Product Development will oversee the development of protein drug product presentations and processes, ensuring robust supply for clinical trials and commercialization. This role involves managing tech transfers and GMP manufacturing operations while providing strategic guidance across cross-functional teams.

product-development communication reporting operations leadership compliance

APPLY

Associate Director, Manufacturing Science and Technology

Apogee Therapeutics · Full Time · 5 months ago

Apogee Therapeutics

🌎 Worldwide 💵 $175K - $195K per year ⭐ 10+ yrs exp 💼 Others

The Associate Director will support late-stage development and commercialization activities, engaging with CDMO partners to ensure robust production of Drug Substance for monoclonal antibodies. Responsibilities include developing control strategies, supporting GMP manufacturing, and collaborating with cross-functional teams.

communication science supply-chain

APPLY

Associate Director, Biostatistics

Apogee Therapeutics · Full Time · 5 months ago

Apogee Therapeutics

🌎 Worldwide 💵 $195K - $215K per year ⭐ 10+ yrs exp 💼 Others

The Associate Director of Biostatistics will act as the statistical lead for projects, providing technical leadership and statistical support for clinical studies. Responsibilities include authoring statistical sections of documents, overseeing vendor teams, and ensuring statistical integrity in study results.

sas communication leadership organization statistics

APPLY