Sr. Clinical Operations Process & Study Training Specialist

 

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, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking   an experienced Sr. Clinical Operations Process & Study Training Specialist to support the development and implementation of study-specific training across all programs via the Learning Management System (LMS), ensuring that cross-functional study teams receive comprehensive training on study protocol and procedures. The ideal candidate will support adherence to GCPs, SOPs, and regulatory agency guidelines while maintaining knowledge of study operational processes to ensure study training compliance. This role may also be involved in supporting the implementation of best practices and processes in support of operational excellence and inspection readiness. Additionally, you will engage in regular communication with internal study team members to provide study training updates, support the management of study training effectiveness, address potential study training challenges across therapeutic areas, process all training assignments/requests and troubleshoot routine inquiries in real-time.

Key Responsibilities

• Support and Maintaining Training Content:
  • Support and uploading course materials within the LMS platform, including e-learning modules, videos, quizzes, and assessments, tailored to specific clinical trial protocols and study procedures.
  • Assign and link study training documents through the LMS.

• Managing LMS Platform:
  • Administering the LMS, including user access control, assigning courses to appropriate staff, tracking course completion, and generate reports on training progress and compliance.
  • Support in the development and the maintenance of a cross functional role-based study training matrix.

• Facilitating Training Delivery:
  • Support the delivery of instructor-led training sessions, both in-person and virtually, for clinical study teams.

• Compliance Oversight:
  • Support with ensuring all training materials and delivery methods adhere to relevant regulatory guidelines (e.g., GCP, ICH) and company standards.

• Identifying Training Gaps and Addressing Issues:
  • Monitor learner performance through assessments and identifying areas for improvement, providing targeted training interventions (i.e. lessons learned, CAPAs, workshop and email blast) when necessary.

• Support in SOP Development
  • Provide support in SOP development and supporting documentation.

• Collaboration with Clinical Operations Leadership and key Stakeholders:
  • Work closely with clinical operations teams and/or cross functional teams to align training needs with study requirements.

• Inspection Readiness
  • Support in inspection readiness exercises with team related to study training and any reconciliation or gap processes.
  • Ensure effective preparations for regulatory inspections related to study training.
  • Support strategic initiatives in preparation for agency inspection readiness.

Ideal Candidate

• A bachelor's degree and relevant professional experience are required
• A minimum of 5 years of clinical related experience.
• Proficiency in LMS with knowledge of utilization features is required
• Ability to develop engaging and effective study training materials, including e-learning modules and presentations
• Knowledge of the principles and practices of SOP management as applied to the pharmaceutical/biotech or contract research organization industry related to study training
• A solid understanding of clinical research with thorough understanding of clinical trial processes, regulatory requirements, and GCP guidelines pertaining to study training requirements
• Attention to detail and commitment to quality
• Excellent interpersonal and decision-making skills
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver department objectives
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with cross functional teams and within assigned timelines
• Experience working in a growing, fast paced organization
• Collaborative team-player
• Excellent written and verbal communication to deliver study training effectively and interact with diverse stakeholders
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 20% travel - including 2 All Hands Meetings plus functional meetings

The anticipated salary range for candidates for this role will be $110,000 - $135,000 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.

 

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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• 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

 

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