Senior Director, Clinical Data Sciences - Translational & Clinical Development (TCD)
Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™.
Vir Biotechnology is seeking a Senior Director to develop and execute our Translational and Clinical Development roadmap integrating Data Science and real-world data (RWD) into innovative clinical development plans, study designs, and integrative data analysis across our clinical development portfolio. Reporting to the Senior Vice President of Clinical Development, you will accelerate development pace and increase probability of success from Phase I through Phase 4 studies.
This role is open to remote employees. Vir only supports employees within the United States and reserves the right to approve work locations. Preference given to candidates residing in the San Francisco Bay Area.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Elevate TCD data science capabilities together with interdisciplinary teams to design and analyze clinical trial data incorporating RWD, formulate innovative clinical questions for biobanked samples that will inform product development, and validate decentralized clinical trial endpoints
- Collaborate with Data Science, Clinical Development Subteams, Program Teams, and Evidence Value and Access (EVA) to design clinical trials (target populations, endpoints, etc), leverage RWD in randomized controlled trials (RCT), and link RCT to large external RWD studies
- Partner with EVA in using RWD to identify burden of disease, patient subgroups, endpoint validation and other health economic and outcomes research analyses to understand where new therapies may add value
- Collaborate with interdisciplinary teams including biometrics, data management, IT, data science teams to implement Vir's enterprise data architecture, structure, systems, and analytics
- Represent TCD in the design, implementation, and adherence to Vir's enterprise-wide data governance frameworks and systems to ensure strategic use of clinical data, while applying innovation and efficiency
- Work with relevant stakeholders to establish and maintain global clinical data governance policies, standards, and procedures
- Leading digital/data science transformation projects in clinical development
QUALIFICATIONS AND EXPERIENCE:
- MD (or non-US equivalent of M.D. degree) or PhD in Biostatistics, Epidemiology, or a related field
- 8+ years' work experience required for MD or 13+ years' work experience required for non-MD in pharmaceutical industry with a proven success record in clinical research studies and trial design
- Experience in the design, conduct, and data interpretation of clinical trials and large epidemiologic studies and analyses
- An understanding of RCTs vs. RWD and clinical questions that can be addressed by integrative analysis and how to leverage RWD to improve the generalizability of RCT findings
- Experience with foundational statistical principles/methodologies and a strong track record of applied experience leading to successful program support
- Experience leading digital, data science transformation, and clinical data integration projects in clinical development
- Knowledge of ICH/GCP guidelines, FDA and EMA regulations, and statistical requirements/process for regulatory submission
- Experience using strategic communication to develop successful partnerships and matrix teams in an inclusive environment of respectful, open, and honest dialogue to deliver complex projects
- Experience engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
- Evidence of autonomous analytical skills, creativity, and high productivity through prior work experience, projects, awards and publications.
- Experience working with abstract ideas or situations across functional areas of the organization to assess and evaluate fundamental issues and provide strategy and direction
The expected salary range for this position is $225,500.00 to $329,500.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir’s compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite personnel!
Vir Biotechnology (“Vir”) is an equal opportunity employer. All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.