Description

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 Pharmacology & Pharmacometrics, the Associate Director/Director, Clinical Pharmacology & Pharmacometrics (PMx) will contribute to the Model-informed Drug Development (MIDD) strategy and execution across preclinical, translational and clinical stage programs. 

This role may be based in our Waltham, MA or remote. Our office-based employees are required to work in the office three (3) days a week. Travel to headquarters for meetings may be required at the discretion of management. 

Responsibilities (including, but not limited to):

• Serve as the CPP representative on studies or program teams, and provide clinical pharmacology expertise to across-function study team, for the assigned studies or programs
• Design dedicated Phase I clinical pharmacology studies, and provide clinical pharmacology input on all clinical study designs through Phase 3
• Contribute to Phase I -III study protocols, and write or review clinical pharmacology sessions for Phase I-Phase III CSRs. Author and review clinical pharmacology sections for clinical and regulatory documents (e.g., INDs, IB, BD, NDAs)
• Understand the “fit-for-purpose” MIDD strategy, and to execute the study level strategy, to accelerate the program advancement
• Provide hands-on Clinical Pharmacology & PMx support and expertise to multiple studies for the assigned program
• Conduct exploratory NCA/PK analysis independently; and work closely with ClinPharm programmer/pharmacometrician on PPK, or PK-PD or ER models
• Collaborate with across-functional teams including but not limited to: in vitro/preclinical pharmacology, translational science, preclinical Tox, clinical, and CMC
• Maintain current understanding of global regulatory expectations and approaches in clinical pharmacology
• Manage and collaborate with CROs, as needed
• Support the interpretation and presentation of scientific and clinical data to internal department, and program team

Requirements

• Requires a PhD degree or equivalent with a minimum of 8+ years of combined academic and biotechnology or pharmaceutical experience in Clinical Pharmacology,
• Pharmacometrics, and/or Translational Sciences, including experience with therapeutic antibodies
• Demonstrated success contributing preclinical or translational, and clinical pharmacology related aspects across different stages of programs
• Demonstrated relevant experiences in addressing global regulatory inquiries, and preparing regulatory interactions
• Prior experience in clinical pharmacology with in-depth knowledge of ClinPharm principles, interpretation of PMx results with Pharmacometricians, as well as track record supporting this experience
• Independent proficiency in NCA, or PKPD, or PPK, or ER analyses, via Phoenix, or Monolix, or NONMEM or R or other software
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Highly motivated and results-driven to deliver for corporate goals in a dynamic biotech environment
   

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.