Apogee Therapeutics is hiring a Clinical Trial Manager to lead the operational execution of global clinical trial programs from Phase I through Phase III. You will be accountable for ensuring adherence to GCP, SOPs, and regulatory guidelines while managing study timelines, budget, and quality. In this role, you will partner closely with CROs and vendors to achieve study milestones and build relationships with key opinion leaders and site staff.
What You'll Do
- Oversee study scope, quality, timelines, and budget with internal functional leads, CRO, and vendors.
- Initiate and build strong relationships with key opinion leaders and clinical site staff.
- Partner with the CRO to develop and implement robust patient enrolment and data monitoring strategies.
- Proactively identify and manage study-related risks.
- Develop and manage clinical trial documents, including protocols, Case Report Forms (CRFs), and consents.
- Review and manage study-related plans and processes, including Investigator agreements, site budgets, and data/safety monitoring plans.
- Collaborate with Regulatory/CRO teams on regulatory submissions.
- Review CRO and vendor contracts, work orders, and system specifications, and participate in User Acceptance Testing.
- Participate in data cleaning and manage database lock activities with the cross-functional team.
- Oversee essential document review to enable timely site activations.
- Direct investigator performance and adherence to protocol.
- Participate in TMF review and ensure the study remains “inspection ready.”
- Oversee and coach the functional activities of Clinical Trial Associates on the project.
What We're Looking For
- Bachelor’s degree in life science or equivalent.
- Minimum of 5 years of clinical trial management experience conducting international trials in a Sponsor Pharma/Biotech organization.
- Prior Phase II and III experience.
- A solid understanding of the drug development process, ICH guidelines/GCP, and each step within the clinical trial process.
- Proven proficiency in overseeing complex studies managed in-house and by a CRO.
- Demonstrated ability to lead teams, work in a fast-paced, cross-functional environment, and think critically and creatively.
- Experience selecting and managing clinical vendors.
- Enjoys building relationships with KOLs and site personnel.
- Demonstrated ability to build and deliver on patient enrolment strategies.
- Demonstrates innovation, drive, energy, and enthusiasm to deliver program objectives.
- Ability to review and comprehend complex scientific concepts and clinical data.
- Strong planning, time management, and coordination skills.
- Demonstrated problem-solving ability and clear judgment regarding regulatory requirements, external interactions, and complex programs.
- Excellent written and oral communication skills.
- Position requires up to 35% travel, including mandatory in-person attendance at company meetings and travel to clinical sites or conferences.
Nice to Have
- Biotech experience strongly preferred.
Team & Environment
You will join a growing Clinical Operations team at Apogee Therapeutics. We operate in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly.
Benefits & Compensation
- Compensation: $145,000 - $160,000 per year + equity grant opportunities.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity, and health, welfare & retirement benefits.
- Three weeks PTO, two one-week company-wide shutdowns a year, and dedicated paid sick leave.
- Commitment to professional growth and access to resources for development.
- Regular all-team, in-person meetings to build relationships and problem-solve.
Work Mode
This position is remote.
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.
