Director, Clinical Scientist Oncology - Vir Biotechnology, Inc.
San Francisco, CA
About the Job
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir's clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies.
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.
THE OPPORTUNITY
The Clinical Research Oncology group at Vir Biotechnology, Inc. develops and executes early development clinical strategies with a mission to deliver medically-differentiated therapies that provide meaningful improvement to patients. The Director in Clinical Research Oncology role provides an exciting opportunity to participate in the growth and expansion of the group. Working in collaboration with the broader Clinical Research Oncology team, the Director in Clinical Research Oncology leads several aspects of new and ongoing clinical study-related activities. These activities encompass, leading functional area activities during program implementation, clinical study startup, execution, data analysis, regulatory submissions, data reporting, and study close out.
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO
- Be the clinical study lead for one or more studies and is responsible for implementation and execution of assigned clinical study activities
- Represent Clinical Research Oncology on sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary contact for questions and inquiries to Clinical Research Oncology regarding studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting
- Provide scientific and clinical leadership to study team(s)
- Provide clinical science expertise at study team meetings in and collaborate with study team members
- Support clinical development planning (in collaboration with the Program Executive and Medical Monitor to support future planning)
- Maintain an understanding of assigned protocols and protocol requirements
- Plan and lead the implementation all study startup/conduct/close-out clinical science activities as applicable, and in collaboration with Clinical Operations
- In collaboration evaluate innovative study designs
- Lead protocol and informed consent form (ICF) development process with; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
- Lead site-facing activities such as training and serving as primary contact for clinical questions, triage with medical monitor as needed
- Manage activities related to data generation and validation, including case report form (CRF) design, clinical data review/query resolution; ensure consistent, quality data review
- Develop data review plan (in collaboration with Data Management), conduct clinical data trend identification; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Review development of site and clinical research associate (CRA) training materials and presentation at site initiation visits (SIV) and Investigator meetings and support on study committees (e.g., safety assessment committee) activities
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of regulatory documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
- Mentor junior clinical scientists as needed
WHO YOU ARE AND WHAT YOU BRING
- PhD, PharmD or equivalent
- At least 10+ years of experience in oncology clinical research (in an academic, pharmaceutical company, or CRO environment) related to the design and/or conduct of clinical studies is required
- Proficiency in GCP/ICH, drug development process, study design, statistics, clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, safety review committee, and independent date monitoring committees
- Results driven and able to achieve creative and sound outcomes
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment
- Ability to make sound and timely decisions; agile in learning and action oriented
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $194,000 to $284,000. 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 each day in the office.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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.
For hires based in the United States, Vir Biotechnology, Inc., participates in E-Verify.
