Director, Clinical Pharmacology (Temporary) at Vir Biotechnology
Vir Biotechnology · San Francisco, United States Of America · Hybrid
- Senior
- Office in San Francisco
Vir Biotechnology 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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of 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 where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
Vir Biotechnology is looking for Director, Clinical Pharmacology (Temporary) who will lead the design, execution, interpretation and reporting of clinical pharmacology data across all stages of drug development. In this role you will work collaboratively with internal and external cross-functional teams to support the successful and timely advancement of drug development programs. You present clinical pharmacology data and strategy to internal teams, acting as a technical expert on cross-functional project teams and sub-teams. You should have a strong understanding of and ability to guide quantitative/modeling efforts in collaboration with PMX colleagues.
This is temporary 6 month role reporting to the Senior Director, Clinical Pharmacology.
This role is based in our San Francisco California office with the expectations to be onsite 4 days a week.
WHAT YOU'LL DO
- Represents clinical pharmacology on cross functional project teams and subteams
- Leads development of fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization
- Work collaboratively with cross functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory in support of program advancement
- Lead the design and execution of Ph1 clinical pharmacology studies (i.e FIH, relative bioavailability, bioequivalence, hepatic impairment, renal impairment, etc)
- Provide expertise in dose selection, optimization, and justification, working collaboratively with PMX to leverage modeling and simulation approaches (PK/PD, PopPK, exposure-response)
- Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages) and RTQs
- May provide guidance to junior clinical pharmacologists in analysis and reporting of study level clinical pharmacology data and drafting of clinical pharmacology sections of protocols, CSRs, IBs
WHO YOU ARE AND WHAT YOU BRING
- PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field
- 10+ years industry experience in Clinical Pharmacology
- Ability to communicate complex data and concepts to diverse audiences
- Deep understanding of the multidisciplinary requirements for drug development and ability to work effectively across functions to enable program advancement
- Extensive experience leading translational and clinical pharmacology work from FIH dose selection through market authorization
- Ability to design and facilitate operation and reporting of various Phase 1 studies and contribute to Phase 2/3 studies with respect to dose selection/justification and sampling strategy
- Experience contributing to clinical pharmacology plans and clinical pharmacology components of regulatory submissions as well as representing clinical pharmacology in regulatory engagements
- Extensive experience with biologics, including monoclonal antibodies, bispecifics.
- Experience leading clinical pharmacology strategy for oncology and/or immunology indications preferred. Familiarity with clinical pharmacology strategies for immune modulating agents
- Proficiency using standard PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc)
WHO WE ARE AND WHAT WE OFFER
The expected hourly rate for this position is $98.00 to $137.00 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
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.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us 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, participates in E-Verify.
