Senior Clinical Trial Manager

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

Reporting to the Associate Director of Clinical Operations, the Senior Clinical Trial Manager will be responsible for the implementation of clinical trial activities for the Dravet Syndrome development programs. Working closely with investigative site personnel, CROs, and other study vendors, the Sr. Clinical Trial Manager will assist the Clinical Team with the conduct of clinical trial activities in accordance with SOPs and applicable regulations. Serve as the primary unblinded operational lead for a global study across the US, UK, and Australia, operating as an unblinded CTM with strict separation of blinded and unblinded activities.

Workplace Model: San Francisco Bay Area (Hybrid) or Remote

Responsibilities

Primary Role & Leadership

• Serve as the primary unblinded CTM supporting a blinded study team
• May be the operational lead on a trial under the supervision of Sr. Director of Clinical Operations 
• Ensure rigorous separation of blinded and unblinded responsibilities

 Unblinded Oversight & Governance 

• Participate in unblinded team meetings with other unblinded meetings, as needed
• Support inspection readiness for unblinded operations
• Management of unblinded documents in the TMF 

Site & Dosing Execution 

• Support clinical supply and the clinical site with drug shipment and receipt prior to dosing
• Provide on-site support for dosing visits
• Build and maintain strong relationships with neurosurgeons and senior investigators
• Perform site management activities that must remain unblinded
• Oversee drug shipment, accountability, and reconciliation with sites and vendors 

Core Trial Operations 

• Manage defined aspects of clinical trials to ensure trials are completed on time and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
• Perform the activities associated with the implementation and monitoring of clinical trials such as development of study plans and materials
• Work with Medical Monitor and Sr. Director of Clinical Operations to select investigative sites, train investigators and investigative site staff, and prepare materials for investigator meetings
• Assist with maintaining study timelines including identifying and communicating trial issues that will impact budget, resources and/or timelines 

Data Quality & Monitoring 

• Review and critique electronic CRFs for accuracy and completeness; oversee data discrepancy management and training as needed
• Conduct oversight monitoring activities as needed 

Vendors, Process & Governance 

• Manage external Vendor partners.  Includes review of invoices for accuracy compared to vendor contract; may aid in the development of technical specifications for vendors (e.g. scope of work)
• Assist in creating and implementing departmental procedures in compliance with industry standards and regulatory requirements 

Other

• Travel up to 40-50% (US and some international)
• Contribute to wider organizational goals and/or activities as assigned

Requirements

• BS/BA or MS degree, or equivalent combination of education and experience in a science or health-related field
• 8+ years of relevant experience with a bachelor’s degree or 6+ years with a master’s degree, including 1–2 years of people leadership and/or hands-on clinical trial management, monitoring, and study document development
• Prior experience in unblinded CTM or similar unblinded sponsor-side roles
• Expert knowledge of FDA and ICH guidelines, Good Clinical Practice (GCP), medical terminology, and clinical trial conduct
• Demonstrated success working with key external stakeholders, including KOLs, Therapeutic Area Experts, Principal Investigators, Study Coordinators, and external partners and vendors
• Comfort interacting with neurosurgeons and senior investigators
• Strong interpersonal skills with a reputation for collaboration and influence up, down, and across the organization
• Outstanding written communication skills, including authoring technical documents such as protocols, amendments, informed consent, and other trial-related materials
• Demonstrated problem-solving abilities with strong organizational and prioritization skills
• Self-motivated, detail-oriented, and able to manage a high volume of work in a fast-paced environment
• Ability to work independently in a small, hands-on biotech setting
• Proficiency with word processing, spreadsheet, database, presentation, and filing systems
• Willingness and ability to travel 40–50%+, including international travel

Preferred Qualifications

• Rare disease, gene therapy program and/or CNS disease experience
• Previous independent on-site monitoring experience 

For candidates based in the SF Bay Area, the expected base salary range for this role is $129,000–$158,000.

For candidates based outside the SF Bay Area, the expected base salary range for this role is 119,000 - 145,000.

The actual base pay offered will depend on factors such as experience, skills, and location. Employees in this role are also eligible to be considered for an annual bonus and receive stock option grants.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, length of experience within the industry, education, etc.

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked kitchen
• Purple Tie dry cleaning service
• Fitness center

Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.

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