We are seeking an experienced and motivated medical writer who is responsible for providing clinical and regulatory document support and advanced medical writing expertise to cross-functional teams, ensuring the successful and timely preparation of high-quality documents. This individual will also participate in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents and will represent Medical Writing at various team meetings. This position reports to the Director of Medical Writing.

Key Responsibilities

• Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: protocols, investigator’s brochures, clinical study reports, briefing documents, Module 2 summary documents, and other clinical and regulatory documents.
• Communicates deliverables needed, writing process, and timelines to team members, and holds team members accountable to agreed-upon document milestones.
• Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals
• Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication.
• Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials.
• Oversees the planning, coordination, and execution of medical writing projects by external vendors and consultants to ensure milestones are met and resources are allocated efficiently.
• Leverages AI-enabled tools to enhance efficiency and quality of medical writing deliverables while maintaining scientific rigor and regulatory compliance.
• Helps define and implement best practices for the responsible use of AI within medical writing workflows.
• Provides guidance to less experienced medical writers and external vendors.

Ideal Candidate

• Bachelors in science (advanced degree is a plus), with 8+ years of experience in medical writing in the pharmaceutical or biotech industry.
• Ability to understand, critically analyze, and interpret data and summarize complex results in an unambiguous, concise, and scientifically accurate manner
• Well-developed interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships
• Proven organizational skills and the ability and flexibility to work across a variety of teams and manage multiple competing priorities in a fast-paced startup environment
• Experience with independently authoring a range of scientific documents and the ability to oversee such authoring done by third parties
• Detail-oriented, with exceptional organizational and project management skills
• Proficient in using scientific writing tools (eg, Microsoft Office suite, document management systems, reference management software) and ability to quickly learn new software applications.

The anticipated salary range for candidates for this role will be $160,000-$180,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

Role Summary

We are seeking an Associator Director, Monitoring Oversight Management, to manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials.  This role will also support contract Oversight CRAs globally.  In this role, you will serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs and contribute to building a culture of team, site and patient centricity.  Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical.  This role will also contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

Key Responsibilities

In-house responsibilities

• The Associate Director of Monitoring Oversight Management is responsible for the leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
• Responsible for hiring in-house Oversight CRAs
• Assist with creation, review and revision of departmental SOPs and policies, as applicable
• Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Assist with creation and delivery of department initiatives, improvement plans and/or training
• Create SOPs and process to support the responsibilities of the monitoring excellence organization
• Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
• Contribute to development and implementation of risk-based monitoring strategies
• Assist monitoring head with resourcing/capacity management projections across clinical studies and/or therapeutic areas
• Contribute to overall operational readiness to support clinical operations monitoring oversight activities across studies and/or therapeutic areas
• Facilitate resolution of region specific and site management related challenges
• Communication and issue resolution with clinical vendors, as needed
• Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools)
• Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
• Periodic review of monitoring visit reports and metrics, as applicable
• Responsible for ensuring Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections
• Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports

Field management responsibilities

• Conduct periodic quality visits for Senior Oversight CRAs, as needed
• Ensure all site oversight visits are completed within the expected timelines globally
• Oversee all timelines and KPIs for the oversight monitoring team globally
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites

Ideal Candidate

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry
• Minimum 5 years of experience leading a team of CRAs
• Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred
• Experience working in Phase I – III clinical trials
• Recent experience working on trials utilizing risk-based monitoring models
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Strong understanding of clinical trial processes and study conduct
• Excellent organizational and time management skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment and can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year, travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office
• This position may also require US and international travel to clinical sites and/or medical conferences

The anticipated salary range for candidates for this role will be $180,000-$205,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Senior Associate, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. You will have the opportunity to support the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will be a data steward of regulatory information, working closely with Regulatory Operations.

Key Responsibilities

• Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness
• Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards
• Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones
• Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation
• Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments)
• Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness
• Support inspection readiness activities (e.g., TMF health checks, document completeness reviews)
• Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes

Ideal Candidate

• BS (or equivalent) in related scientific discipline
• 2+ years of experience working in the pharmaceutical/biotechnology industry (regulatory affairs experience preferred)
• Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently
• Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders
• Proven proficiency in MS Word, Excel, Power Point; SharePoint/Teams (preferred)
• Experience working in Veeva Regulatory Information Management (RIM) platform and eCTD submissions (preferred)
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year.

The anticipated salary range for candidates for this role will be $120,000-$135,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an experienced biotech project manager to optimize planning, execution, and tracking of development-stage global regulatory activities. This role will be a key member of the team supporting regulatory activities and regulatory execution for clinical trials across the portfolio.  In collaboration with the Regulatory team, you will drive global submission planning and coordination across multiple regions, ensuring alignment with Regulatory, Global Development, and Technical Operations objectives.  The ideal candidate is a proactive, detail-oriented project manager with global regulatory experience who thrives in a face-paced, collaborative biotech environment.

Reporting to the Director of Program management, you will also work closely with other project and program managers within the Program Management Office (PMO) implementing robust PM processes and building effective tools and systems. You’ll support optimization of Regulatory project plans, schedules, stakeholder communications, and Smartsheet operations. The role involves developing and managing high-visibility regulatory submission plans, monitoring milestones, managing documentation, and contributing to regulatory strategy.

Key Responsibilities

• This role blends regulatory expertise with advanced project management skills, developing complex plans to enable successful Regulatory submission activities and ensuring cross-functional integration across regions
• Track and coordinate timelines and deliverables to support complex regulatory submission activities (IND/CTA/BLA/NDA/MAA) across multiple regions, as well as responses to queries and correspondence with subject matter experts
• Work with the Regulatory team to translate strategic regulatory vision into actionable project plans, ensuring all cross-functional activities are coordinated and delivered on time
• Organize and facilitate cross-functional meetings to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide
• Monitor CTA/IND submission status across assigned projects
• Support strategic planning and risk mitigation efforts related to regulatory activities, including portfolio level analyses that identify resource bottle necks across all programs and studies
• Support evaluation, implementation, and use of project management tools (especially Smartsheet); define methodologies and reporting frameworks
• Design and maintain Smartsheet sheets, reports, dashboards, and forms related to regulatory activities and ensure integration with program plans
• Troubleshoot and enhance PMO solutions, support system updates and new capabilities
• Demonstrate critical thinking and initiative to improve PM practices

Ideal Candidate

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field
• 5+ years of experience with at least 3+ years of project management experience in pharmaceutical or biotech industry is preferred
• Experience with planning IND/CTA regulatory submissions required
• Familiarity with components of regulatory submissions is required
• Experience planning BLA/NDA/MAA submissions is required
• Familiarity with CRO operations and global regulatory requirements for clinical trial applications
• Experience supporting global interventional clinical studies and CTA submissions
• Hands-on Smartsheet experience; Smartsheet Core Product Certification or equivalent desirable
• Proficiency in project management tools (Smartsheet, ThinkCell, PowerPoint, Excel, SharePoint, Office Timeline Pro). Familiarity with regulatory systems (Veeva RIM) preferred
• Knowledge of biotech processes, scientific terminology, drug development concepts
• Proactive and structured approach to problem-solving, with ability to think cross-functionally and in multiple timeframes, and to distill into actionable plans/solutions
• Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities and meet deadlines
• Ability to work independently and thrive in a dynamic environment
• Team player that contributes valuable ideas and feedback and can be counted on to meet commitments
• Position requires up to 20% travel; this includes mandatory in person attendance to company All-Hands meetings held twice a year, additional travel may be required to attend key meetings, typically held at the Apogee San Francisco or Boston offices

The anticipated salary range for candidates for this role will be $150,000-$170,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

• Support the statistical programming function by implementing programming processes, standards, and SOPs for clinical trials
• Contribute to the development and maintenance of SAS programming infrastructure, processes, and data standards
• Lead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverables
• Manage and oversee CROs and external vendors to ensure quality and compliance with expectations
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions
• Develop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teams
• Review and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROs
• Review SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming input
• Mentor and develop programmers, fostering a high-performing and collaborative team environment
• Provide hands-on support for complex analyses and ad hoc requests as needed
• Drive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflows

Ideal Candidate

• Master’s Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
• A minimum of 12–15 years of progressive clinical trial programming experience in the biotech/pharma industry, including leadership experience
• Advanced SAS programming skills: experience with R or other statistical programming languages preferred
• Strong experience and in-depth knowledge of CDISC standards (SDTM, ADaM) and controlled terminology
• Experience supporting regulatory submissions (e.g., NDA/BLA/MAA)
• Knowledgeable in AI use in drug development and ambitious in leveraging AI to build infrastructure/workflows to expedite submission process
• Excellent organizational skills with the ability to manage multiple priorities
• Strong communication and interpersonal skills, with the ability to collaborate cross-functionally
• Experience managing CROs and external data vendors
• Demonstrated ability to mentor team members and contribute to team development
• Advanced knowledge of statistical programming methodologies in clinical study settings
• Knowledge of ICH guidelines and FDA / EMA / other regulatory authority requirements
• Experience working in a fast-paced, growth-oriented environment
• Experience working in a remote/virtual environment
• Experience with AI-driven tools or automation in clinical data analysis and regulatory submission processes (e.g., AI-assisted generation, validation, or review of submission deliverables)
• Familiarity with modern data platforms, cloud environments, or scalable analytics infrastructure
• Experience in a small to mid-size biotech environment
• Strong leadership with a collaborative and growth-oriented mindset
• High attention to quality and detail
• Adaptability and ability to operate effectively in a fast-moving environment
• Commitment to fostering a psychologically safe and inclusive team culture
• Alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
• Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office

The anticipated salary range for candidates for this role will be $270,000 - $295,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an Executive Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness. This role verifies compliance with cGMP regulations, company policies and procedures, and industry standards, while deliberately designing quality systems that enable speed, clarity, and confident decision-making as the company scales.

The Executive Director partners closely with cross-functional teams and external manufacturing and testing partners ensuring high standards of product quality and data integrity across GMP operations. They build and lead a high‑performing GMP QA team, provide strategic oversight of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management. This position reports to the Head of QA.

Key Responsibilities

• Head of GMP QA and member of the QA Leadership Team
• Build, lead, and scale a high‑performing GMP QA team
• Develop and execute the GMP QA functional strategy, ensuring alignment with company objectives and evolving clinical‑to‑commercial needs
• Establish a clear GMP QA vision that enables inspection readiness, scalability, and sustainable operations
• Provide oversight of GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition
• Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH)
• Lead organizational readiness for GMP internal audits and regulatory inspections
• Provide strategic oversight of GMP QA across CMOs, CDMOs, and external testing partners
• Ensure effective quality agreements, oversight models, escalation pathways, and performance metrics are in place and actively managed
• Exercise sound judgment in resolving quality issues with external partners in a timely and compliant manner
• Engage effectively with leadership and key cross‑functional partners, bringing forward clear recommendations and risk‑based perspectives
• Lead the development and presentation of Quality Management Review meetings for GMP QA to highlight compliance needs and to foster continuous improvement initiatives to support speed, clarity, and scalability

Ideal Candidate

• 15+ years of progressive GMP QA experience within pharmaceutical, biotechnology, and/or medical device environments, with deep understanding of global GMP regulations across clinical and commercial operations
• Proven track record leading GMP QA organizations through the transition from clinical development to commercial manufacturing, including launch readiness and post approval operations
• Demonstrated success building, scaling, and sustaining GMP Quality Systems to support commercial supply, including serving as functional lead for the Veeva Quality Suite (QMS) with accountability for system strategy, governance, and compliance across internal teams and external partners
• Extensive experience overseeing external manufacturing and testing partners, and directly leading regulatory inspections and interactions with global health authorities
• Significant leadership experience, including managing managers and senior level professionals; effective at coaching and developing leaders through change and uncertainty
• Ability to create and clearly articulate a GMP QA vision aligned with company strategy, establish trust and credibility across teams, and set clear direction while adapting leadership style to organizational and individual needs
• Sound, unbiased judgment in complex and ambiguous situations; makes pragmatic, well-reasoned decisions, takes full ownership of outcomes, proactively addresses challenges, seeks feedback, and continuously adapts strategies based on evolving risks and business needs
• Strong written and verbal communication skills
• Ability to operate effectively in a fast‑paced, evolving environment with incomplete information
• Demonstrated commitment to Apogee’s C.O.R.E. values and ethical decision‑making
• Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend visits to vendors, CDMOs, etc., domestic and international travel is required 

The anticipated salary range for candidates for this role will be $275,000-$305,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an Associate Director of Statistical Programming. In this position you will be responsible for leading statistical programming activities to support various clinical trial projects. You will also support building programming processes for clinical studies and submissions as they relate to clinical goals to ensure successful execution of Apogee’s clinical programs. You will manage programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

Key Responsibilities

• Serve as a lead statistical programmer on one or more clinical studies
• Provide statistical programming oversight to programming vendors
• Review and validate datasets and TFLs programmed by vendors
• Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion
• Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate
• Participate in developing and implementing statistical programming processes and standards
• Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective
• Build and mentor a team of programmers to support clinical trials and pipelines
• Generate ad hoc analyses on ongoing basis

Ideal Candidate

• Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
• A minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry
• Advanced SAS programming skills and experience in other statistical software, such as R, etc.
• Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies
• Excellent organizational skills and ability to prioritize tasks
• Excellent communication and interpersonal skills
• Experience managing CROs and other data vendors
• Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Ability to keep pace in a fast-moving organization
• Advanced knowledge of state-of-art statistical programming methods in clinical study setting.
• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience working with in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office

The anticipated salary range for candidates for this role will be $190,000-$210,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a dynamic and experienced MSAT Associate Director to support late-stage development through launch/commercialization activities. Central to success will be engaging with CDMO(s) to deliver processes that enable robust production of Drug Substance (DS) for monoclonal antibodies. This interdisciplinary position will provide expertise across cell line, cell culture, purification, and formulations, including scale-up from lab to manufacturing scale. 

Embedded in the Drug Substance Development and Manufacturing team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.  

Key Responsibilities

• Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
• Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
• Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
• Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations
• Analyze process and manufacturing data to understand and optimize process performance
• Develop process characterization and PPQ strategies and documentation
• Support regulatory activities including submissions and site inspections from preparation through execution
• Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
• Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
• Author and review internal procedures, reports, and presentations, as needed

Ideal Candidate

• PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience
• 7+ years of biologics development and manufacturing experience
• Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
• Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support
• Experience with process and economic modeling of DS manufacturing processes
• Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
• Ability to multi-task and keep pace with a fast-moving organization
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Availability to participate in calls across multiple international time zones
• Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend visits to vendors, CDMOs, etc. domestic and international travel is required

The anticipated salary range for candidates for this role will be $175,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join our team. You will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes and device development activities (pre-filled syringes, autoinjectors, etc.) This position will work closely with cross-functional teams to establish, maintain, and continually improve Apogee’s quality systems. You will support our mission to develop and deliver differentiated biologic therapies to patients in need.

Key Responsibilities

• Assist QA Leadership with development and execution of planned QA audit schedules supporting GMP activities
• Partner with Technical Operations with selection and ultimate oversight of drug substance / drug product contract development manufacturing organizations (CDMOs) in support of Phase 3 and process performance qualification (PPQ) activities
• Independently performs assigned GMP audits
• Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated
• Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement
• Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products
• Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards
• Provide QA support of device development activities (pre-filled syringes, autoinjectors, etc.)
• Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events
• Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures
• Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization
• Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality
• Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
• Ensure employees are adequately trained in GMP requirements and quality procedures
• Maintain comprehensive and accurate records and reports related to quality assurance activities
• Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety
• Assist in GMP inspection readiness activities to support regulatory authority inspections

Ideal Candidate

• A bachelor’s degree in relevant scientific discipline or equivalent is required, advanced degree a plus
• A minimum of 8 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in auditing and the manufacture of monoclonal antibodies or biologics
• Experience with CDMO oversight, including partnering and aligning on quality issues
• Experience with Quality Management System Regulations is a plus
• In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with analytical instrumentation, methods, validation, and investigations including stability program management
• Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
• Strong communication (oral and written), and effective interpersonal skills with the ability to influence and drive change
• Excellent problem-solving and critical thinking abilities
• Flexible and creative to meet the needs and challenges of a growing, dynamic company
• Focus on fostering a culture of collaboration and teamwork
• Ability to manage multiple projects with fast timelines and changing priorities
• Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend visits to vendors, CDMOs, etc. domestic and international travel is required

The anticipated salary range for candidates for this role will be $165,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an Associate Director, Analytical Development to join our team. This newly created position is a highly collaborative leadership and technical position based in our Research and Development lab in Boston.

You will manage and lead Analytical Development activities to support early to late phase programs, including monoclonal antibodies and other biologics modalities. These activities include supporting developability screening studies, method development, non-GMP analytical characterization, comparability and R&D sample testing. In this role you will be an important member of the Tech Ops team, managing multiple activities in parallel at various stages of drug development.

Key Responsibilities

• Design, develop, and implement analytical methods for the testing and characterization of biologics programs including monoclonal antibodies and other biologics modalities. The work will include partnership with contracted partners and/or internal analytical capabilities.
• Design, manage and execute experiments to support developability screening, upstream/downstream process development, process transfer, formulation studies, product characterization and comparability studies.
• Develop and execute analytical strategies with other stakeholders in support of the product and analytical method lifecycle, ensuring compliance with safety, quality, and regulatory requirements.
• Demonstrate technical excellence in method development and analytical characterization/comparability of biologics; build strong partnerships and collaborations internally and externally.
• Collaborate with cross-functional teams, including process development and R&D, to support project goals and timelines.
• Analyze and interpret complex data sets, providing clear and actionable insights and recommendations.
• Prepare technical reports, presentations, and documentation to communicate findings and progress to stakeholders.
• Author and review analytical sections of IND, IMPD, BLA, and MAA submissions.
• Stay current with industry trends, advancements to continuously improve analytical capability, methodologies and practices.

Ideal Candidate

• PhD in Analytical Chemistry, Biochemistry, or related field, with a minimum of 7 years of relevant industry experience in an analytical development role, preferred.
• Demonstrated expertise in managing analytical development initiatives for monoclonal antibodies and other biologic modalities, encompassing method development, product quality assessment, characterization, and comparability studies.
• Deep expertise in several analytical techniques such as mass spectrometry, H/UPLC (SEC, IEX, RP, HILIC,), electrophoresis (CE-SDS, icIEF) and/or biophysical methods. Experience in ELISA, bioassay and potency assays is preferred.
• Experience in working with external contract organizations (CDMO, CRO, etc.) to deliver key analytical deliverables.
• Strong problem-solving skills and the ability to lead, design, troubleshoot, and conduct complex experiments.
• Excellent communication skills with an ability to collaborate effectively across functional lines.
• Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
• Familiarity with regulatory requirements and guidelines (e.g., FDA, ICH) related to analytical development and comparability
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 35% for company-wide meetings as well as Tech Ops team meetings.
• This hybrid role requires approximately two days per week onsite at our laboratory in Boston (Seaport area).

The anticipated salary range for candidates for this role will be $175,000 – $195,000 /year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Senior Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. Reporting to the Director of Regulatory Affairs, you will have the opportunity to oversee the implementation of regulatory strategies for Apogee’s products in collaboration with project teams and the regulatory affairs department. In this highly visible role, you will lead the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will serve as the primary interface with regulatory publishing to ensure timely and compliant submissions and represent regulatory affairs on clinical study and execution teams.

Key Responsibilities

• Lead and coordinate interactions with project teams, clinical study teams, management, consultants, and collaborators to facilitate timely acceptance/approval of regulatory submissions including INDs, CTAs, NDAs, BLAs, and PIPs/PSPs, among others
• Support the data collection and cross-functional authorship for regulatory documents. Proofread, edit, and prepare documents for inclusion in regulatory submissions; coordinate with multiple departments to obtain content needed for submissions
• Communicate timelines for regulatory submissions to individuals and departments and follow up to ensure timely submission
• Serve as the primary interface with regulatory publishing to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed
• Appropriately archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
• Implement and maintain use of standardized templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and advice to team members
• With mentoring and guidance from the regulatory affairs leadership team, understand and communicate US and international regulatory requirements to ensure quality documents are submitted either directly or in collaboration with a CRO or corporate partner
• Support global regulatory leads on clinical study and execution teams to ensure that clinical trial deliverables, timelines, and objectives are met

Ideal Candidate

• BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline
• Regulatory Affairs Certification (RAC) credential preferred
• A minimum of 5 years of regulatory experience working in drug development in the biopharmaceutical industry
• Experience interacting with health authorities including FDA and EMA
• Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally
• Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Experience working in Veeva Regulatory Information Management (RIM) platforms, eCTD submissions, and Microsoft Office SharePoint/Teams
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

The anticipated salary range for candidates for this role will be $155,000-$175,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

The Department of Research and Translational Medicine is seeking a Clinical Biomarker Operations Sr. Manager. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, contracts, and budget management.

Key Responsibilities

• Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition.
• Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications.
• Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions.
• Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance.
• Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships.
• Support QA in vendor audit and inspection activities.
• Support activities related to biomarker budget planning and tracking of accruals.
• Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards.
• Continuously identify and build best practices for process improvements.
• Ensure high quality data generation by overseeing sample integrity and external collaborations.

Ideal Candidate 

• MS or higher with > 3 years or BS with >5 years of direct experience in biomarker operations role.
• Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage.
• Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking, and final reconciliation of activities.
• Experienced in all phases of clinical trials, Phase 3 experience is an asset.
• Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays, and drug development in general.
• High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines.
• Experience in I&I indications.
• Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines.
• Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Ability and willingness to travel, including a minimum of ~4 times per year for All Hands meetings and other workshops.

The anticipated salary range for candidates for this role will be $150,000-$170,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

The Senior Manager of Clinical Systems serves as the clinical systems manager and technical lead for clinical technology initiatives. This position is responsible for the oversight, planning, and execution of end-to-end clinical system processes from start up through archival. This role combines clinical systems expertise with strong technical project management capabilities, ensuring successful delivery of system implementations, integrations, and enhancements.

This position will provide technical and business management in support of system compliance and inspection readiness, while driving structured execution of cross-functional initiatives. The role requires strong collaboration across Clinical, IT, Quality, and external vendors to manage timelines, risks, dependencies, and change management activities. This position will also lead efforts to define requirements, promote adoption of processes and standards, act as a point of escalation and ensure alignment with company goals, culture, and vision.

Key Responsibilities

• Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors.
• Lead and manage clinical system programs and projects end-to-end, including scope definition, planning, timeline management, resource coordination, and execution tracking.
• Manage and support clinical system (insourced and outsourced) related projects, with a focus on IRT, site portals, CTMS and eCOA, acting as a project/program manager.
• Establish and maintain project governance, including risk management, issue tracking, dependency management, and executive status reporting.
• Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner.
• Translate business and clinical requirements into technical specifications, ensuring alignment with IT, validation, and vendor teams for successful system implementation.
• Ensure compliance with clinical system SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles, applicable regulations, GCP requirements, and industry standards.
• Generate and report KPIs, metrics and analytics, identifying trends across the clinical systems portfolio, areas for improvement, and implementing changes as needed.
• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required.
• Lead and support development and implementation of processes, procedures, supporting tools, and related training materials that adhere to regulatory requirements and industry best practices.
• Collaborate with Information Technology (IT), Quality Assurance, and Clinical System Validation teams to ensure effective system implementation, integration, and lifecycle management, including releases, updates, bug fixes, and enhancements.
• Oversee system integrations and data flows across platforms (e.g., CTMS, IRT, eCOA, eTMF, LMS), ensuring data integrity and interoperability.
• Create and provide clinical system training. Act as a primary support role for clinical system users and stakeholders.
• Execute change management activities to ensure consistent application of revised standards, processes, and systems functionality, including validation.

Ideal Candidate (Enhanced with Technical PM requirements)

• Bachelor's Degree or higher or equivalent experience.
• At least 10 years of experience successfully managing clinical system activities for clinical research/biotech/pharmaceutical organizations.
• Experience implementing and managing eCOA, IRT, eTMF, CTMS and LMS (Veeva Vault experience preferred).
• Experience with implementation and integration of clinical systems and writing/revising SOPs related to clinical systems.
• Experience with computer system validation/assurance processes.
• Demonstrated experience applying project management methodologies (Agile, Waterfall, or hybrid) to deliver complex, cross-functional technical initiatives.
• Proven ability to define project scope, timelines, milestones, and resource plans, and manage execution with clear accountability.
• Strong program management skills, including risk management, dependency tracking, issue escalation, and stakeholder communication.
• Working knowledge of data management principles, including data quality, data governance, and data lifecycle management in clinical systems environments.
• Ability to interpret and analyze data outputs, dashboards, and KPIs to drive operational decisions and continuous improvement.
• Familiarity with AI/ML concepts and terminology (e.g., automation, predictive analytics, NLP) and their practical applications in clinical operations.
• Familiarity with software development lifecycle (SDLC) processes, including requirements gathering, UAT, release management, and post-implementation support.
• Proficiency with project management and tracking tools (e.g., Smartsheet, MS Project, or similar).
• Experience managing teams in the successful execution of projects; knowledge of records management practices in pharma/biotech or CRO environments.
• Strong software and computer skills, including Microsoft Office applications.
• Knowledge of relevant licensing and industry compliance regulations.
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Demonstrated effective written and verbal communication skills with internal and external stakeholders, including the ability to communicate complex technical concepts clearly.
• Able to lead initiatives and communicate effectively through presentations for external and internal audiences.
• Excellent organizational skills with outstanding attention to detail and follow-through.
• Able to work independently and function as a team player.
• Able to navigate complex problems, develop advanced concepts, anticipate challenges, and propose solutions.

Optional

• PMP, PgMP, or equivalent certification preferred.
• Experience in high-growth biotech or startup environments.

The anticipated salary range for candidates for this role will be $150,000-$165,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

We are seeking an Associate Director, Clinical Operations Standards and Planning to join our Clinical Operations Team. This position will be responsible for the identification, documentation, maintenance and optimization of Apogee Clinical Operations standards and best practices to support a growing portfolio of global clinical trials. This position will lead the Clinical Operations organization to identify innovative strategies to increase operational efficiency across programs.  Additionally, this role will provide oversight of the Clinical Operations resource planning process to support the Clinical Operations Leadership Team in ensuring appropriate resources are available at the right time to support the Apogee portfolio. This role will report into the Executive Director Process and Strategic Planning and will be a key leader within the Clinical Trial Excellence Team.

Key Responsibilities

• Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team
• Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation
• Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s
• Collaborate with Apogee Process Excellence and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness
• Oversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization
• Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organization
• Develop, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globally
• Collaborate with cross functional Clinical Study Team members to develop end-to-end clinical operations process, tools and resources
• Collaborate with Clinical Study Team members and CRO to develop necessary standard practices to meet clinical trial country specific operational requirements
• Lead and participate in key process improvement initiatives to ensure continuous process improvement
• Lead any assigned departmental activities to support a highly functioning Clin Ops organization

Ideal Candidate

• Minimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations related role
• Bachelor’s degree required
• Experience in operationalizing large, global clinical trials and providing oversight of CRO’s and other vendors
• Experience driving innovation in clinical trial operations to increase efficiency and implement best practices
• Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellence
• Experience managing CROs, vendors and/or clinical trial consultants
• Strong leadership, communication, and interpersonal skills, with the ability to influence and align diverse groups across functions at all levels of the organization
• Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, an major Health Authority regulations
• Systems thinker with process optimization mindset and ability to build structure in dynamic, high-growth environments
• Strong project management skills, effective matrix leadership, and the ability to deliver
• Strong analytical and forecasting capabilities with demonstrated experience in capacity modeling, utilization optimization, and data-driven decision-making
• Ability and thrive in a fast paced, dynamic environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 30% travel

The anticipated salary range for candidates for this role will be $175,000 - $195,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Clinical Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. 

Key Responsibilities

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met 
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget for assigned regions
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study related risks
• Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents
• Review and manage study related plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan
• Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions
• Review CRO and vendor contracts/work orders and specifications to align with study objectives
• Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, EDC)
• Participate in data cleaning and manage database lock activities with cross functional team
• Oversee review and approve essential document packages to enable timely site activations
• Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Participate in TMF review and ensure quality and completeness throughout end of the study
• Ensure the study is always “inspection ready” 
• Oversee and coach the functional activities of Clinical Trial Associates allocated to the project 

Ideal Candidate

• Bachelor’s degree in life science or equivalent
• Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization.  Biotech experience strongly preferred.  
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Proven proficiency in overseeing complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively
• Experience selecting and managing clinical vendors to support study activities
• Enjoys building relationships with KOLs and site personnel
• Demonstrated ability to build and deliver on patient enrolment strategies
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to review and comprehend complex scientific concepts and clinical data
• Strong planning, time management, and coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Excellent written and oral communication skills
• Position requires up to 35%travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. 

The anticipated salary range for candidates for this role will be $145,000- $160,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a highly motivated and results-oriented individual to join Apogee Therapeutics in an Associate Director, Clinical Supply Chain Management role. In this position, you will be responsible for managing the end-to-end clinical supply chain for multiple clinical programs, ensuring the timely and efficient delivery of investigational products, comparators, and ancillary supplies to support global clinical studies.  This role will collaborate closely with cross-functional teams including Clinical Operations and Development, Regulatory Affairs, Manufacturing, Quality, and external partners to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards. The position is fully remote and reports to a senior member of the Clinical Supply Chain management team.

Key Responsibilities

• Strategic Supply Chain Planning:
• Develop and implement clinical supply strategies to meet study timelines for complex programs that require multinational interactions by reviewing clinical trial synopsis’ and/or protocols to understand IMP supply and demand requirements.
• Prepare demand forecast(s) using simulation and/or forecasting tools, ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered.
• Partner with Clinical Operations and other stakeholders to determine demand assumptions, such as number of patients and clinical sites, countries/regions, enrollment rates, etc.
• Collaborate with manufacturing to develop drug product delivery schedules to meet demand.
• Optimize supply chain operations to minimize waste and ensure availability of investigational medicinal products (IMP) and materials while maintaining a low risk profile.
• Establish SOP’s and work instructions required to manage clinical supply.

• Clinical Supply Management:
• Oversee the procurement, packaging, labeling, distribution, and return of clinical trial materials, ensuring quality standards and regulatory compliance.
• Manage the label development process.
• Manage vendor relationships for outsourced supply chain services, including distribution centers, packaging vendors, and courier services.
• Develop IRT User Requirement Specifications and conduct User Acceptance Testing.
• Conduct supply chain risk assessments, proactively identifying and mitigating potential disruptions to supply continuity.
• Inventory & Distribution Oversight:
• Maintain inventory management systems to ensure accurate tracking and traceability of all clinical materials.
• Monitor inventory levels at depots and clinical sites through the life of a trial and coordinate resupply efforts to prevent stockouts or overages.
• Ensure timely and compliant distribution of IMP to clinical trial sites globally, adhering to country-specific regulations and customs requirements.
• Regulatory Compliance & Quality Assurance:
• Ensure compliance with all regulatory guidelines (e.g., FDA, EMA, ICH) and Good Distribution Practices (GDP) across all clinical supply chain activities.
• Support regulatory inspections and audits by maintaining thorough documentation of supply chain activities.
• Collaborate with Quality Assurance to manage deviations, CAPAs, and continuous improvement initiatives.
• Leadership & Cross-functional Collaboration:
• Lead and mentor one or more clinical supply chain professionals, providing direction, training, and development opportunities.
• Serve as a key point of contact with multiple functional areas and act as a liaison between internal departments and external partners to ensure alignment on clinical supply chain goals and timelines.
• Participate in cross-functional project teams to drive supply chain efficiencies and resolve challenges as they arise.

Ideal Candidate

• S/M.S. degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or related field with 12+ years of relevant experience in supply chain management and 5+ years in a leadership role. Certification in Supply Chain Management or Project Management a plus
• Experience with inventory and supply chain management for complex global clinical trials using Microsoft Excel based models and SaaS forecasting tools
• Operations experience in a biotech or pharmaceutical company, start-up experience a plus
• Third-party selection and management experience is required
• Knowledge of import/export requirements and significant experience with international clinical supply
• Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP)
• Proven ability to manage multiple projects, proactively identify and mitigate risks, and resolve issues using strong attention to detail and problem-solving skills
• Experience developing and managing program budgets
• Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity
• Strong knowledge of Microsoft Office, including Excel and PowerPoint, and Smart Sheet
• Excellent communication and influencing skills, strong collaboration skills
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Ability and willingness to travel up to 15% (domestic and internationally) including a minimum of 2 times per year for All Hands meetings

The anticipated salary range for candidates for this role will be $170,000-$190,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an inspirational and dynamic Regional Director (RD), Field Medical Affairs (Dermatology) to lead and expand our Medical Science Liaison (MSL) team in the East region.  The ideal candidate will have an advanced clinical or scientific degree and experience in field medical affairs leadership within dermatology.  In this newly created role, you will lead the MSL team to meet the field scientific objectives of the Clinical Development Medical Affairs (CDMA) organization.  Your  primary focus  will include  MSL coaching and development, territory planning and cross-functional collaboration to support our clinical trials and corporate strategy.

Key Responsibilities

• MSL Leadership and Development - lead, coach and manage a team of MSLs
• Provide strategic direction, professional development, and performance management in a timely and consistent manner, regularly recognize strong performance and address performance gaps decisively
• Consistent field observations to provide MSL coaching and development and build relationships with key opinion leaders (KOLs) and investigators
• Regional execution of Medical Affairs strategy and objectives, ensure MSLs are equipped to engage with healthcare professionals (HCPs), KOLs, and other external stakeholders, delivering scientific and medical information that aligns with corporate strategy
• Regional oversight of MSL territory planning to achieve Medical Affairs objectives/goals
• Ensure MSLs have resources, tools and training to maximize field performance and enhance the support of KOLs and investigators
• Responsible for MSL team compliance, monitor and evaluate MSL activities, ensuring compliance with regulatory guidelines and internal policies
• Collaborate closely with cross-functional teams
• Provide scientific expertise and insights to help guide strategy and internal decision-making

Ideal Candidate

• Advanced scientific degrees are required (PharmD, PhD, MD/DO, PA, NP), Doctorate strongly preferred in health sciences or clinical discipline
• Minimum of 7 years of experience in Medical Affairs and 5 years of experience in field medical affairs
• MSL leadership experience required
• 2+ years of experience in the dermatology therapeutic area strongly preferred
• Excellent communication and presentation skills
• Proven history of establishing and maintaining relationships with KOLs
• Ability to work in a fast-paced, dynamic biotech environment with a collaborative, cross-functional mindset
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 75% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, as well as regular overnight travel to meet with MSL team, clinical study site personnel and KOLs, and to attend scientific conferences, etc.

The anticipated salary range for candidates for this role will be $250,000 - $280,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an Associate Director of Biostatistics. In this position you will be acting as the statistical lead for one or multiple projects, providing technical leadership and statistical support on the study design, project planning, conduct and execution of clinical studies, and scientific publications. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity.

Key Responsibilities

• Contributor on regulatory submissions
• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Apogee’s clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations
• Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
• Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners to achieve results for specific project needs
• Ensure the delivery of high quality and timely reports to project teams and clinical trial team

Ideal Candidate

• PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered
• A minimum of 8 years’ experience in progressive and relevant clinical trial experience
• Experience with phase 3 study and regulatory submission is preferred
• Experience leading teams and working in a matrix organization
• Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
• Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
• Experience managing CROs and other data vendors
• Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Ability to keep pace in a fast-moving organization and navigate ambiguity
• Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including missing data imputation, multiplicity adjustment, estimand, Bayesian method, etc.
• Knowledge and proficiency in SAS or R and other industry computational tools
• Knowledge of CDISC standard including SDTM, ADaM
• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience in planning, running and documenting simulations, including clinical trial simulations
• Experience working in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office

The anticipated salary range for candidates for this role will be $195,000 - $225,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Clinical Monitoring Manager to oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity.  Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The Clinical Monitoring Manager has ‘in-house’ responsibilities (e.g., oversight CRAs), and as required by project scope, sponsor monitoring or co-monitoring visits at the clinical study sites.

The Clinical Monitoring Manager collaborates closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives.

Key Responsibilities

In-house responsibilities

• The Clinical Monitoring Manager is responsible for the study deliverables of in-house CRAs on a given study(s), ensuring study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
• May be responsible for the hiring of in-house CRAs
• Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms)
• Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plans, site visit report templates, monitoring tools)
• Support the training and development of in-house CRAs and ensuring study training compliance is maintained
• Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery
• Oversight of review of monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
• Responsible for oversight of CRA review of clinical data (e.g., electronic case report forms, eCOA data, central laboratory data, risk-based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site’s data with quality and integrity
• Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Lead, conduct, and document regular meetings with their in-house and CRO CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Oversee the study specific performance of the CRA team(s) and implement plans of action as needed; escalate performance issues to the Executive Director, Clinical Operations
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports
• Assist with review and revision of departmental SOPs and policies
• Assist with creation and delivery of new department initiatives, improvement plans or training
• May assist with the identification and selection of appropriate clinical trial sites and investigators

Field monitoring responsibilities

• Conduct CRO co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
• Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines
• Review and ensure data integrity, accuracy, and completeness at the clinical study sites
• Escalate site related issues to the study team
• Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready, as needed

Ideal Candidate

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry
• Minimum 2 years of experience leading a team of CRAs
• Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Recent experience working on trials utilizing risk-based monitoring models
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Strong understanding of clinical trial processes and study conduct
• Excellent organizational and time management skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.
• Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.

The anticipated salary range for candidates for this role will be $150,000 - $170,000. per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an Associate Director to join the QC Analytical Sciences team in Analytical Development & Quality Control to lead the execution and provide technical and operational oversight of analytical testing to support product development and quality control activities across Apogee’s pipeline. This role focuses on performing and supporting QC testing, method lifecycle activities, and data review to ensure compliance with cGMP and regulatory requirements. Working closely with cross-functional teams and external partners, this individual will be an important member of the TechOps team, contributing hands-on expertise to product release, stability programs, and regulatory submissions across the development pipeline, by managing multiple parallel activities at all stages of product development.

Key Responsibilities

• Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations.
• Partner with global and cross-functional teams to ensure successful implementation of harmonized methods.
• Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements.
• Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues.
• Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines.
• Generate and review technical documents, including protocols, reports, and method lifecycle documents.

Ideal Candidate

• Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
• 7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
• Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
• Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
• Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
• Excellent communication skills with an ability to collaborate effectively across functional lines
• Ability to work independently and multi-task in a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

The anticipated salary range for candidates for this role will be $165,000 - $185,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Director, Drug Product Development to develop protein drug product presentations and processes, oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization. Reporting to the VP of Formulation and Drug Product Development, this position requires deep expertise in process development, aseptic manufacturing for prefilled syringes (PFS), combination product development, and compliance, while fostering collaboration across teams and external partners. This person will be a subject matter expert in drug product manufacturing, including PFS, within the CMC organization, providing strategic guidance and technical leadership across cross-functional teams.

Embedded in the Formulation and Drug Product Development team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain. 

Key Responsibilities 

• Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams
• Develop late-phase and commercial launch strategy for PFS development and manufacturing
• Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support
• Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members
• Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness
• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
• Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies
• Analyze manufacturing data and identify opportunities for process improvement and optimization
• Support formulation and co-formulation development for protein therapeutics, including antibodies
• Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
• Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Ideal Candidate 

• Minimum of 10 years industry experience in drug product development and manufacturing
• 5+ years of experience in clinical and/or commercial Good Manufacturing Practice (GMP) operations for PFS drug products, ensuring regulatory compliance and operational excellence across all phases of manufacturing
• Demonstrated leadership in GMP manufacturing of combination products
• PhD in relevant discipline (e.g. chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience
• Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies
• Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations
• Experience with process performance qualification (PPQ) and commercialization of biologics
• Experience with pre-approval inspection (PAI) readiness and support is preferred
• Experience with drug product process extractables / leachables risk assessments is preferred
• Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory
• Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams
• Availability to participate in calls across international time zones
• Position requires up to 25% travel including travel to domestic and international sites. In person attendance at Apogee All Hands meetings is required, typically held twice per year.

The anticipated salary range for candidates for this role will be $210,000 to $235,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.