Chief Development Officer

Description

At Viridian, 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, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success.

We value teamwork, 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.

Reporting to the Chief Medical Officer, the Chief Development Officer will have overall clinical leadership and will be responsible for delivering on the clinical goals for the TED and FcRn franchises.

This includes oversight of clinical strategy and clinical development plan for VRDN’s product candidates. In addition, this role will be integrally involved in the preparation for commercialization with respect to product labeling and medical input into commercial activities and the scientific basis of the pricing and value proposition strategy.

This person will be the clinical team’s voice and representative at the cross-functional program team that oversees the overall clinical strategy for Thyroid Eye Disease and the FcRn portfolio.

In this role the Chief Development Officer will also partner across the organization to provide clinical insight to (early stage / pre-clinical) asset evaluation, lead global clinical development and therapeutic area strategies, advise on global trial deployment, and provide medical oversight on ongoing trials.

This role may be remote or may be based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule.

Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to) :

• Provide overall clinical, scientific & value content for all TED and FcRn programs
• Direct biostatistics, medical monitoring / PV, and clinical development teams
• Partner with clinical operations and global CROs to ensure smooth, safe trial implementation, training, and new processes and systems deployment
• Act as the single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GxP
• Ensure internal and external peer review of potential study / program design. As available, provide clinical strategic input to in-licensing opportunities
• Ensure all development activities comply with regulatory requirements and standards, working closely with the regulatory team and regulatory bodies to achieve approvals for new therapies
• Support as appropriate within the Program during issue and crisis management as directed by the CMO
• Timely provision of Medical Scientific strategies for clinical components of the TPP, CDP, and core labelling texts
• Organize and deliver Advisory Boards with international Key Opinion Leaders (KOLs)
• Provide BOD and investor updates, as needed

Requirements

• Requires a Medical Degree; U.S. licensure and Board Certification in a relevant therapeutic area are strongly preferred
• A minimum of 20+ years’ experience across all phases of therapeutic development for multiple indications, in a bio-pharmaceutical / pharmaceutical company (minimum 10 years), medical monitoring within a global CRO, and / or clinical practice in a relevant therapeutic area
• Experience in Phase 3 program development and trial conduct, as well as NDA / BLA submissions strongly desired
• Demonstrated ability to lead the development of project strategy and be accountable for project plans, timelines, progress, and outcomes
• Demonstrated ability leading and motivating teams in a matrix environment
• Demonstrated ability to lead, coach, and mentor junior physicians / scientists
• Significant hands-on clinical drug development experience and scientific credibility
• Experience with Clinical - Commercial interface
• Extensive knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Global regulatory submissions and interacting with major Health Authorities
• Developed / delivered in parallel, composed of multiple complex and large studies (e.g., including but not limited to multinational outcome studies)
• Demonstrated ability to cultivate excellent cross-functional collaborations
• Demonstrated ability to effectively communicate at multiple levels of the organization
• Named Investigator on a number of clinical trials is preferred
• Significant and consistent peer-reviewed publication track record is preferred
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 20%
• 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
• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• 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.