Senior Director, Clinical Pharmacology

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 SVP of Research, the Senior Director, Clinical Pharmacology will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies, and will be accountable for delivering key translational milestones from candidate selection to BLA.

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

Responsibilities

(including, but not limited to)

:

Scientific oversight for translational BLA and IND enabling studies, including exploratory and GLP PK/TK studies, PD and biomarker development, biodistribution studies, and development of reagents and assays for Anti-Drug Antibody (ADA) assessment

Ensure compliance with regulatory requirements and industry standards for translational and clinical pharmacology related research activities

Mentor and develop a high-performing translational science team, fostering a culture of innovation and scientific rigor

Manage CROs and translational scientists that will be interfacing with Research and Development groups as new therapies are advanced

Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of non-clinical data to support clinical programs and regulatory applications

Author and review PK, TK, PD, ADA and associated translational study reports in support of regulatory submissions

Closely collaborate with clinical development to conduct translational components of planned clinical studies

Contribute to the design execution of program translational strategies integrating both disease and pathway approaches

Support execution of early and late clinical trials through BLA submission

Responsible for the strategic planning, authoring, and review of the translational biology components of regulatory documents, scientific data and publications

Identify significant issues and risks that may impact overall project plans and initiate contingency plans as appropriate

Contribute to departmental resource planning, budgeting and timeline setting to meet company needs

Manage CROs conducting translational studies

Contribute to scientific and clinical interface with key opinion leaders (KOL), facilitating KOL advocacy development

May provide line management, oversight and coaching to more junior research/clinical staff

Represent Research and Translational Science for project teams when presenting project and governance meetings

Lead or participate in cross-functional working groups such as scientific and safety review boards

Identify and collaborate with academic investigators to optimize the translational strategy and plans for programs

Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings

Requirements :

Requires a PhD degree with a minimum of 12+ years of combined academic and biotechnology or pharmaceutical experience in Clinical Research, Clinical Pharmacology, and/or Translational Sciences, including experience with therapeutic antibodies

Prior experience in translational science with in-depth knowledge of PK, TK, and PD principles, biomarker development, and biodistribution studies, as well as a significant publication track record supporting this experience

Deep understanding of and direct clinical experience in immunology, inflammation, and/or endocrinology, in both early and late stages of development

Hands on experience with modeling and simulation based approaches, including population based PK modeling, exposure response modeling, and model based dose selection.

Strong understanding of the regulatory requirements for translational research, drug development and submission activities

Broad and deep understanding of approved and investigational therapies for these disease areas

Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

Prior industry experience in the preparation of clinical protocols, study reports, IND, IB, BLA/CTD documents

Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements

Demonstrated ability as a scientific and or medical expert in a complex matrix environment

General familiarity with biostatistics and/or pharmacometrics; expert in navigating scientific literature, interpretation of data, display of data

Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures

Ability to work well in a fast paced, innovative and performance driven environment

Demonstrated ability to integrate scientific rationale, target biology, clinical strategy, and target product profile to develop appropriate translational strategies

Demonstrated ability to simultaneously work on complex projects requiring an in-depth evaluation of multiple, interdependent factors

Ability to prioritize responsibilities and meet deadlines

Ability to self-motivate and work independently

Attention to detail, experience in monitoring work to assure quality, accuracy and thoroughness

Outstanding communication skills with the ability to effectively converse with a variety of audiences including team members, cross-functional project teams, project leaders, KOLs and senior management

Demonstrated ability to think strategically and solve complex scientific problems, as well as ability to work at the strategic and tactical level

Demonstrated ability to contribute successfully in a multi-disciplinary team environment while serving as a team lead

Excellent problem-solving abilities with a focus on accomplishing company goals and objectives in a dynamic business environment

Strong focus and drive to succeed

Comfortable challenging the status quo and bringing forward innovative solutions

Strong commitment to ethical standards

Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well PK modeling software (Phoenix, R, or NONMEM).

Ability to travel up to 20%

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.

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