Sr. Manager, Clinical Development Operations

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the VP of Clinical Development, the Clinical Development Operations Manager will support all aspects of clinical development operations across programs, including operational excellence and clinical study activities. The Clinical Development Operations Manager will perform ongoing clinical data review to support database lock activities, maintain departmental SOPs, support inspection readiness activities, develop departmental standard processes and document templates, and support authoring and reviewing key trial data-related documents.

This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including, but not limited to):

• Lead Clinical Development Operations excellence by developing standard processes and document templates to facilitate the development of deliverables of high quality in accordance with industry standards and within agreed upon timelines
• Support the VP of Clinical Development in collaborating with clinical leadership and cross-functional study teams to execute clinical studies, with scientific integrity, from protocol concept through the clinical study report
• Lead Clinical Development owned SOP development and life-cycle management per Viridian Quality and industry standards and requirements
• Responsible for upload and QC of Clinical Development CSR appendices in the Viridian document management system
• Support Clinical Development inspection readiness activities including participating in audits and preparing responses to audit findings as applicable
• Position focuses on aligning clinical development processes across programs, creating consistency in interactions with CROs and cross-functional teams
• Collaborate closely with Clinical Operations colleagues on Clinical Development responsibilities for clinical study activities and timelines, including Informed consent development and review, data management activities and review of data management plans and other documents, management of Clinical Development TMF responsibilities, and supporting the management of clinical development document deliverables to meet the operational needs of the program ensuring process optimization and consistency across programs
• Support Clinical Development in the activities associated with execution of clinical studies and data collection, including review of case report forms; participating in user acceptance testing (UAT), identification of protocol deviations (PDs) and review of associated documents (Protocol Deviation Assessment Plan and PD tracker); and resolution of issues
• Support overall clinical data review including data listings review to detect data trends and ensure data quality in coordination with cross-functional teams and engaged vendors
• Support patient profile listing review and other data related activities in preparation for database locks
• Stay current with GCP and worldwide regulatory requirements

Qualifications:

• Requires a Bachelor’s degree in Life Sciences and 8+ years’ experience or an advanced degree with 5+ years’ experience (or commensurate with other relevant Life Sciences degree)
• Requires relevant experience in the biotechnology or pharmaceutical industry
• Requires 5+ years clinical experience across all phases of therapeutic development for multiple indications
• Therapeutic area experience in Ophthalmology strongly preferred; Immunology or Neurology is a plus
• Thorough knowledge of FDA regulatory requirements, clinical research concepts & practices, and ICH/GCP guidelines
• Medical Writing experience a plus
• Experience in CRF design, UAT, and conducting clinical data review
• Experience working with and managing third party vendors, such as CRO’s
• Proven ability for strategic thinking, creative problem-solving, and risk identification & mitigation skills
• Team-oriented and works collaboratively as a team
• Demonstrated strong written and verbal communication skills
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Strong attention to detail
• Ability to work in a fast-paced environment and to handle multiple tasks
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 10-20% domestic and internationally
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Competitive medical, dental, and vision coverage
• Fertility and mental health programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.