Associate Director/Director, Bioanalytic Development & Operations (Waltham)

Company Name

Viridian Therapeutics, Inc.

Job Description

Join to apply for the Associate Director/Director, Bioanalytic Development & Operations role at Viridian Therapeutics, Inc..

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, thoughtful 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.

Reporting to the VP, Translational Sciences, the Associate Director/Director, Bioanalytical Development and Operations will be a member of the growing Translational Science team to support ongoing clinical trials of Viridian therapeutic antibody programs, as well as upcoming late discovery programs. The position will be responsible for strategic and operational oversight of the development and validation of pharmacokinetic (PK), anti-drug antibody (ADA), neutralizing antibody (Nab), and biomarker assays to support non-clinical and clinical studies. The right candidate will be confident, passionate, execution-focused, team-oriented, have a can-do attitude, and the ability to work collaboratively with others.

This role may be based in our Waltham, MA headquarters or Boulder, CO offices. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (Including, But Not Limited To)

• Lead and oversee the development, validation, and application of bioanalytical techniques (LC-MS, ELISA, MSD, PCR, cell-based assays) to support PK, PD, biomarker and immunogenicity objectives in non-clinical and clinical studies.
• Serve as the department's subject matter expert and be a team resource for bioanalytical knowledge, strategy, and application in drug development.
• Leverage depth of knowledge and hands-on experience with bioanalytical techniques to advise on assay design, method validation design, and interpretation of method performance data.
• Coordinate and supervise studies conducted at CROs including generation of proposals and SOWs, data generation and analysis, and troubleshooting.
• Author and review bioanalytical reports or summary sections for preclinical/non-clinical/clinical reports, and regulatory documents for initiation of clinical studies (such as IND and CTA) and drug approvals (such as NDA and MAA).
• Prepare, track, and maintain all necessary reagents and documentation associated with bioanalytical assays.
• Oversee and coordinate collection, processing, storage, and reconciliation of clinical trial samples.
• Manage, monitor, and document sample transfer between clinical sites, central labs, and testing labs.
• Collaborate with discovery, non-clinical, and clinical teams to generate reagents and develop assays to meet project timelines.
• Stay abreast of literature, government guidelines, and internal guidance as relates to the development and use of bioanalytical methods.

Requirements

• Requires a BS in biological field and a minimum of 10 years relevant biotechnology industry experience; or an MS degree with a minimum of 8 years experience; or a PhD and a minimum of 5 years of experience.
• Experience with development and qualification of PK/PD and immunogenicity assays in ELISA, MSD, and other formats in both human and animal matrices.
• Deep scientific and technical experience with and understanding of therapeutic antibody non-clinical and clinical development.
• Excellent time management skills and the ability to work with a sense of urgency in a highly collaborative team environment.
• Strong oral and written communication including the ability to present information clearly and logically.
• Ability to prioritize and manage multiple projects to meet critical deadlines.
• Strong attention to detail and problem-solving skills.
• Works effectively in a team environment.
• Strong commitment to ethical standards.
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.).
• The salary range for this position is commensurate with experience.

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.

Seniority Level

• Seniority level: Director

Employment Type

• Employment type: Full-time

Job Function

• Job function: Production

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