Associate Director, Clinical Operations

1 week ago

Boston, MA, United States Solid Biosciences Full time
Associate Director, Clinical Operations - Solid Biosciences

HQ Hybrid or Remote

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich's ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid's mission is to improve the daily lives of patients living with devastating rare diseases.

We are seeking a successful candidate will manage clinical trial activities for multiple trials ensuring the timely completion of deliverables through development, management and oversight of the trial CROs, timeline and budget. Partners with Clinical Development and other functions to develop operationally feasible and clear protocol concepts and final protocols. Must be comfortable independently leading internal study teams, as well as the outsourced activities and responsibilities delegated to CROs and/or other service providers for assigned clinical trials such as, study start-up, monitoring, site management, TMF, laboratories, drug supply and data management, and contribute to biostatistics, medical writing, safety, regulatory affairs and quality assurance activities, where needed. In addition, the successful candidate will interact closely with investigators and site staff through routine calls and site sponsor visits.

This role will report to the Senior Director, Clinical Operations and can be based in Solid's Corporate Headquarters located in Hood Park in Charlestown, MA or done remotely.

Key Position Responsibilities
  • Provide strategic planning expertise, define and implement development program strategy and departmental objectives in alignment with corporate goals.
  • Responsible for effective global management of multiple clinical studies within a clinical development program.
  • Responsible for management of the study teams for assigned studies or programs and of relationships with CROs, central labs, IRB's, investigating sites and other external partners, as needed, for one or more clinical trials.
  • Coordinates the activities of all trial conduct partners and team members and proactively identifies and manages risks
  • Determine patient recruitment strategies, operational feasibility and implementation of study/program objectives
  • Leads development and/or review of all supporting documents for a clinical study, registry or access program. including but not limited to Protocols, Informed Consent Forms, Investigator Brochures, Study Manuals, Statistical Analysis Plans, CRFs, Data Management Plans and Clinical Study Reports.
  • Manage and lead cross-functional clinical trial team meetings collaborating with team members regarding operational activities pertaining to the execution of one or more clinical trial(s)
  • Review clinical operations SOPs and work instructions within a program including, but not limited to, new hire training for CTMs/CRCs, tools, templates, and CRO manuals
  • Identifies, or assists in identifying, investigational sites and participates in reviewing and approving qualified sites
  • Create and review Request for Proposals, vendor specifications and participate in vendor selection process
  • Manages the negotiation of contracts, budgets, and timelines with CROs, vendors, clinical sites, and other external partners
  • Review study invoices and manage accruals for assigned studies monthly
  • Leads the coordination of and training team members and external partners (vendors, sites, etc)
  • Prepare and maintain assigned study and program files, study documentation and other essential documents
  • Provide management with routine updates regarding the status of ongoing studies
  • May participate in internal/external study related audits
  • Ensure compliance to internal processes and GCP
  • Ensure Trial Master File documentation is collected and maintained
  • Attend Investigator Meetings and site visits as needed
Experience Requirements
  • Ability to manage and operationalize a high volume of highly complex tasks within a given timeline
  • Ability to lead cross functional team in a matrix environment
  • Strong multi-tasking, time management, and organizational skills
  • Ability to take initiative and work both independently and in a team environment
Key Position Attributes
  • Minimum BA/BS Degree
  • Minimum 8 years of Clinical Trial Management experience.
  • Must be willing to travel, both domestic and international.
  • Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH regulations and guidelines.
  • Ability to provide appropriate leadership to clinical sites and CROs
    • Detail-oriented individual with good problem-solving capability
Compensation

The base compensation range for this role is: $145,000 - $215,000.
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid's long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees' lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.
  • Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
  • 401(k) program participation with competitive company matched contributions
  • Eligibility to participate in Solid's Employee Stock Purchase Plan
  • Mobile phone subsidy for eligible employees
  • Tuition Reimbursement
  • Vision Coverage
  • Life Insurance
  • Voluntary Pet Insurance
  • Employee Discount Program on Travel, Entertainment, and Services
  • Employee Assistance Programs
  • Daily Subsidized Lunch Delivery (onsite @ Hood Park)
  • Free Onsite Full-Service Gym (onsite @ Hood Park)
  • Employee Parking (onsite @ Hood Park)
  • 12 Observed Holidays and a winter shut down
  • 15-day PTO Policy and a 40-hour rollover YoY
  • 40-hour Sick Policy
  • 8 Hour Floating Holiday

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