Sr. Clinical Trial Manager
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 conditions 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. All positions offer the flexibility to work remotely.
If this sounds like you, keep reading!
Role Summary
We are seeking a Sr. Clinical Trial Manager (Sr. 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. This is a fully remote position.
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(s) to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget
- 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), consent documents, and confidentiality agreements
- Review and manage study related plans and processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring
- Review CRO and vendor contracts/work orders and specifications to align with study objectives
- Review and approve essential document packages to enable timely site activations
- Review pre-study, study initiation, interim monitoring visit and at study closeout visit reports
- Provide close oversight of the monitoring reports and provides updates to the broader team
- Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
- Oversee the TMF maintenance and ensure completeness at the 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 sponsor Pharma/Biotech organization
- 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 functionally environment
- 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
- Ability to travel globally - (up to 20%)
Preferred Qualifications:
- Experience in working in a start-up organization
- Experience with clinical studies in inflammatory and immunological therapeutics areas
- Experience with budget forecasting and management
- $140,000 - $155,000 a year
The anticipated salary range for candidates for this role will be $140,000-$155,000/ 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. To learn more about our C.O.R.E. values and how they manifest day-to-day, click here
- · 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
- · 100% remote with regular all team, in-person meetings to build relationships and problem solve