About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! Role Summary 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. What We Offer - A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless - Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly - Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits - We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave - Commitment to growing you professionally and providing access to resources to further your development - Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Role Description GP Strategies is looking for an Associate LMS Operations Manager to be responsible for managing day-to-day operational activities in the Learning Management System (LMS) and guidance to ensure the Learner experience is the best it can be. In this role, the Associate LMS Operations Manager contributes to LMS related onboarding or enhancement projects, drives the vision towards LMS meeting business needs and serves as a day-to-day point of contact for applicable R&D business areas. Experience with SuccessFactors LMS is preferred but any LMS experience is acceptable. The role has daily contact with Client Stakeholders and the Clients Learners as well as GP Strategies colleagues, around the globe. - Training Matrix Management: - Responsible for the creation, maintenance, and periodic review of training matrices in collaboration with business and course owners. - This includes procedural, Instructor led courses and Online courses, Compliance training, and other relevant items. - Solve issues with Functional and Technical Support teams where needed. - Work with business to obtain assignments for new/updated procedural, instructor led, and Online courses. - Work with course owners and process owners to obtain training content, training information, and exam questions, meeting established standards including version controls, if applicable. - Training Roll Out: - Identify and track new/revised Quality documents that should be uploaded to LMS; ensure alignment with EDMS process and obtain assignments from business. - Liaise with Training Managers to set up new training courses in the LMS and collect the required information meeting the LMS standards and conventions. - Collaborate with stakeholders to ensure successful deployment of classroom courses and publication of AICC/SCORM compliant eLearning courses within the LMS. - Ensure online training is according to technical specifications for LMS. - LMS Maintenance: - Supports ongoing system development, administration, maintenance, testing, and troubleshooting for current and future functionality in collaboration with key stakeholders. - Responsible for monitoring adherence to established data integrity rules, conventions, and processes for the LMS such as course codes, descriptions, and other conventions and performing ongoing Quality Control. - Collaborate with business stakeholders and system vendors to follow up, communicate, and where needed to escalate to solve technical issues affecting LMS operations and ensure incidents are managed to completion. - Contributes to the creation and maintenance of LMS system standards and ensure these are captured and maintained in procedures. - LMS Expansion and Technology Projects: - Support LMS related optimization and integration projects as part of multi-divisional project teams to support LMS or other learning technology system implementation, expansion, and system life cycle upgrade projects. - Reporting and Metrics: - Prepares and provides LMS reports as necessary. - Supports the definition and implementation of LMS metrics and dashboards in collaboration with business/customer. - Vendor Oversight: - Provides guidance to LMS Administrators in daily LMS operations such as curricula administration and record learning management and ensures functional issues are resolved in collaboration with LMS Admins, Tech Support, and customers. Qualifications - Experience with Learning Management Systems (LMS), preferably SuccessFactors. - Strong organizational and communication skills. - Ability to collaborate with various stakeholders. Requirements - Experience in training matrix management. - Knowledge of AICC/SCORM compliant eLearning courses. - Ability to monitor data integrity and perform quality control. Benefits - Competitive salary. - Comprehensive health benefits. - Opportunities for professional development. Company Description GP Strategies Corporation is one of the world's leading talent transformation providers. By delivering award-winning learning and development solutions, we help organizations transform through their people and achieve meaningful change. GP Strategies has delivered our innovative consulting, learning services, and talent technology solutions to over 6,000 organizations globally. With more than 4000 employees in over 30 countries, diversity at GP Strategies is second nature! Beyond our locations, our culture focuses on performance and revolves around respect, fairness, and working collaboratively to achieve our goals. We support our People, no matter who they are or where they are from, because we all have valuable and unique perspectives and approaches. GP Strategies is committed and proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions, sexual orientation, and gender identity), national origin, age, veteran status, disability, or any other federally protected class.

• Provide telephonic and/or live chat needs assessment and screening while managing an inbound EAP phone/chat queue. • Deliver brief, solution-focused, in-the-moment supportive interventions and psychoeducation for concerns including stress, anxiety, grief, relationship issues, and substance use. • Conduct risk assessments for members presenting with concerns such as: suicidal ideation; thoughts of harm to others; substance use issues; risk for abuse or violence. • Provide crisis intervention and stabilization, including safety planning and connection to urgent or emergent resources when indicated. • Explain EAP clinical and work/life benefits and provide individualized recommendations to meet each member’s needs and goals. • Connect members to EAP services and/or health insurance or community resources and follow up to support successful engagement and connection to services, as clinically appropriate. • Participate in individual supervision, team meetings, and case consultation.

• You are responsible for the application and further development of our Quality Management System (QMS) • You actively manage the quality of our suppliers — including audits, scorecards and clear performance management • You analyze quality issues and ensure sustainable solutions are implemented (CAPAs) • You handle communication with authorities in the event of quality incidents • You ensure compliance with all relevant standards (HACCP, IFS, BRC) • You ensure full transparency and traceability of our products • You establish a strong quality culture within the company and will build and further develop your own Quality team over time