Looking for a Director of Pharmacometrics to join our team. REMOTE or ONSITE
San Francisco, California, United States 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
Vir Biotechnology is looking for a Pharmacometrician to lead our pharmacometrics strategy across therapeutic areas and programs, from early clinical development to market application and commercialization. The Director, Pharmacometrics will join the Clinical Pharmacology department and report to the VP of Clinical Pharmacology.
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO
Working in collaboration with the Project Lead Clinical Pharmacologist you will develop and implement model informed drug development (MIDD) plans across projects and disease areas to optimize prospective studies and inform drug development strategy and project decision-making.
With the Project Lead Clinical Pharmacologist you will be responsible for pharmacometrics activities including population pharmacokinetics modeling and simulations, PK/PD and exposure-response.
Conduct modeling and simulations activities for programs across multiple stages of development, from pre-IND through post-marketing.
Present modeling and simulation data as a technical pharmacometrics expert on cross-functional project sub-teams.
Identify opportunities where modeling and simulation can promote the understanding of pharmacological activity, efficacy and safety.
Provide support and help develop our quantitative methodology, pharmacometrics tools, software, hardware, and related business processes.
WHO YOU ARE AND WHAT YOU BRING
PhD with at least 10 years of experience OR MS degree with at least 13 years of experience
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics or biostatistics.
Experience with quantitative modeling including performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, Phoenix) for protein therapeutics (e.g. mAbs, siRNA) and small molecule therapeutics.
Experience managing MIDD (model informed drug development) regulatory strategies together with clinical pharmacology project leads to achieve desired outcomes.
Experience with quantitative systems pharmacology (QSP) and physiologically based pharmacokinetic (PBPK) modeling
Experience with clinical pharmacology studies to support intrinsic/extrinsic factors and the ability to author and defend pharmacometrics components of regulatory filings.
Lead modeling and simulations activities with external CROs.
Mentor junior staff within Clinical Pharmacology.
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WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $194,500 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 for all onsite employees!
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.
External website https://boards.greenhouse.io/virbiotechnologyinc/jobs/4472046005
Contact email address: pharmacometrics@uct.ac.za - 25th Sep 2024 [3169]
PhD student and postdocs in pharmacometrics at the University of Cape Town
We have positions available in our Pharmacometrics research team, both at PhD student and post-doc level.
We are looking for bright individuals with strong quantitative and computer skills who have an interest in biomedical research and health sciences.
For details, please refer to these links https://health.uct.ac.za/pharmacometrics/career
External website https://health.uct.ac.za/pharmacometrics/career
Contact email address: telder@stem-sourcing.com - 25th Jul 2024 [3167]
Senior Director DMPK Search! Our favorite client is expanding rapidly and is need of a DMPK/ADME leader. This role will have direct reports and mentor junior scientists. You'll oversee all aspects of invitro assay development, be responsible for CRO selection and management and champion the preclinical PK aspects of assets throughout the company's portfolio.
You'll need to:
Be onsite at the company's east coast (NJ/PA area) HQ- This is non-negotiable
Have 10+ years experience in industry- in DMPK
Experience in ADME, PBPK, DDI etc.
Please message me to learn more! telder@stem-sourcing.com
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 11th Jul 2024 [3166]
Associate Director Pharmacometrics role available--large pharma and 4 direct reports--two days a week onsite--hands on about 50% of the time--must have NONMEM--will be leading a small US based group for a large pharma and collaborating with overseas counterparts.
Basic Qualifications:
- Hands on use of NONMEM and R
- Solid knowledge of PK/PD and data analysis
- Execute PMx strategy, and lead teams in data -analysis and interpretation
- Experience in drug development
- Author regulatory documents including study reports, popPK reports, E-R analysis, etc.
- Strong leadership and communication skills
- PhD or PharmD with 5-10 years related experience
External website https://broseberry@cartermackay.com
Contact email address: cornelia.boehnstedt@fu-berlin.de - 7th Jul 2024 [3164]
Call for the next generation of talents within the interdisciplinary PhD program PharMetrX
The Graduate Research Training Program PharMetrX: Pharmacometrics & Computational Disease Modelling is an interdisciplinary PhD program bridging pharmacy and mathematics. PharMetrX aims at understanding the drug-patient-disease interaction by analysing data of drug concentration, effect & disease profiles of pre-/clinical trials and of therapeutic care by developing and applying pharmacometric (i.e. PK, PD, disease) mathematical & statistical models.
We are currently inviting applications to enrol in the PharMetrX Research+ Program or the PharMetrX Training+ Program.
The PharMetrX Research+ Program (Research & Training & Network) comprises an excellent research environment in the vibrant Berlin/Potsdam area, fascinating and innovative research projects in a highly relevant field, truly transdisciplinary working groups and supervision, an individual mentorship from one of the associated industry partner consortium, a specifically tailored training program of compact academic and industry modules, a network of 115 peers and a competitive 3.5 years fellowship.
The PharMetrX Training+ Program (Training & Network) offers a specifically tailored training program of compact academic and industry modules that convey the foundations in pharmacokinetics & pharmacodynamics, systems biology, statistics, methodological approaches of modelling & simulation etc. as well as a network of 115 peers. It is open for PhD students who have already started their PhD in the field of pharmacometrics since March or will do so soon.
Both programs are open to candidates with a university degree in pharmacy, pharmaceutical sciences, mathematics/statistics, bioinformatics, life sciences medicine, data sciences or some related field: see https://www.PharMetrX.de.
Deadline for applications: 06 September 2024. Start of Module Curriculum: March 2025
PharMetrX is a joint program of Freie Universität Berlin and the Universität Potsdam, supported by a consortium of global research-driven pharmaceutical companies.
Charlotte Kloft & Wilhelm Huisinga Program Chairs
External website https://www.pharmetrx.de/
Contact email address: broseberry@cartermackay.com - 21st Jun 2024 [3163]
Associate Director, Pharmacometrics role available--hybrid MA or NJ. Please email me for more info at broseberry@cartermackay.com or call my cell 315-415-4353
Main Responsibilities:
- Develop modeling and simulation strategies for optimizing model-informed drug development in all stages of drug development, ranging from first in human dosing through life cycle management.
- Conduct with minimal supervision model-based analyses such as population pharmacokinetics (PPK), PK/PD, exposure response, model-based meta-analysis, clinical trial simulations and disease progression modeling to drive internal pipeline forward
- Conduct innovative quantitative methodologies such as data analytics, machine learning and mechanistic modeling as needed.
- Develop and maintain a comprehensive understanding of global regulatory expectations and best practices for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing pharmacometrics at regulatory meetings when needed.
- Champion pharmacometrics internal/external visibility (e.g., authoring scientific publications, presentation at national and international conferences, participation in internal cross-functional initiatives, etc.).
- Provide scientific mentoring and support junior scientists and participate in the implementation of best practices within pharmacometrics.
About You:
- Education: Ph.D. with or without post-doctoral experience in Pharmacometrics, Biopharmaceutics, Pharmaceutical Sciences, Mathematics, Statistics, Data Science, Computational Biology, Chemical/Biomedical Engineering, System Pharmacology, Computer Science, or closely related discipline
- Experience: At least 5 years of industrial experience with a record of increasing responsibility and independence
- Deep and extensive modeling experiences ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling to advanced complex methodologies such as data analytics, machine learning and mechanistic modeling.
- Proficiency in integrating and analyzing internal and external data to support decision making and to generate scientific insights.
- Extensive experiences in M&S software such as NONMEM, R, Monolix, Phoenix NLME, Matlab, PKsim, SimCYP, Python
External website https://broseberry@cartermackay.com
Contact email address: telder@stem-sourcing.com - 29th May 2024 [3162]
Director or Sr. Director of Clinical Pharmacology and Pharmacometrics-California
Our Client is seeking a highly skilled and experienced Senior Director of Pharmacometrics and Clinical Pharmacology to lead their efforts in early and late-stage clinical drug development (Phase 1-3). The successful candidate will be responsible for designing and implementing pharmacometric and clinical pharmacology strategies that ensure the successful development of innovative therapeutics.
Develop and execute comprehensive pharmacometrics and clinical pharmacology strategies for Phase 1-3 clinical trials.
Oversee the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), dose escalation, bioavailability, bioequivalence, and drug-drug interaction studies.
Ensure timely and accurate interpretation of PK/PD data and its integration into clinical development plans.
Lead the preparation of clinical pharmacology sections of regulatory submissions (INDs, NDAs, BLAs) and represent the company in regulatory interactions.
Lead and mentor a team of pharmacometricians and clinical pharmacologists, fostering a collaborative and innovative work environment.
Proven track record of leading pharmacometrics and clinical pharmacology efforts in the development of novel therapeutics, with successful regulatory submissions. Please message me to learn more
External website https://www.stem-sourcing.com