Director, Clinical Operations - Waltham, United States - Viridian Therapeutics

Description

At Viridian (


NASDAQ:
VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases.

We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success.

We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.

The Director, Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed upon timelines and budgets.

This role reflects the knowledge, experience, skill levels and capacity to manage complex studies or programs.


Responsibilities:

Responsible/Accountable for project related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.

Effectively lead, manage, and develop a team of direct reports who will manage multiple trials and multiple arms.
Accountable for external vendor selection and management, and assists in the development of RFPs and vendor oversight plans
Project leadership of the cross-functional study team, including external team members, CROs and vendors.
Establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines/budget established for the study/studies.

Advises on strategic input on clinical operations pipeline and goals, including input in the overall clinical development plan on a global scale.

Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)
Develops strong, collaborative working relationships with CROs/vendors, key investigators, and other key staff/vendors and cross functional study teams.
Serves as a leader to proactively audit and inspect clinical operations activities for efficiency, quality, and progress.
Partners with team, CRO and cross-function teams to facilitate site engagement and recruitment activities. Ensure site training/communications are occurring as needed.
Prepares study reports and provides ongoing updates for leadership team/meetings.
Facilitate site contracting process, including helping with negotiations and managing site budgets
Develop and implement robust risk identification and mitigation plans to solve complex issues that impact study or program milestones
Support of Clinical Operations projects, infrastructure, and processes (e.g. SOP development and review, financial tracking for assigned project(s), management of clinical systems, oversight of clinical metrics tracking and reporting)

Requirements

BA/BS degree in Health or Life Sciences required, advanced degree preferred

A minimum 10+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring and line management.

A minimum of 5+ years of experience as a manager/leader
Exceptional collaboration, communication, and interpersonal skills
Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheets
Reliable, self-motivated, team player
Detail oriented with excellent organizational skills
Ability to effectively manage multiple tasks and competing priorities

Viridian offers a flexible work environment. This position is a hybrid role based out of our Waltham, MA office. The expectation is to work in the Waltham office, 2 days per week with travel for meetings as required.

Viridian offers a comprehensive benefits package including:
Remote work with technology tools and infrastructure
C ompetitive pay and stock options for all employees
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
Company paid insurance programs
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan

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