- Serving as an expert representative for QP2 -IO on Oncology development teams.
- Framing critical questions and strategy for optimizing model-based analyses on programs.
- Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling into programs, comparator modeling, thereby strengthening our pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
- Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.
- Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.
- Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.
- Ph.
- Masters or PharmD, with at least six years of experience, where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.
- Demonstrated impactful experience with applications of pharmacometrics methods.
- Experience in IND, NDA and other submissions to global regulatory agencies.
- Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
- An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.
- Proficiency in R, NONMEM or other similar programing language.
- Professional working proficiency in written and verbal communication.
-
Revolution Medicines, Inc. Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS p ...
-
REVOLUTION Medicines Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS p ...
-
Structure Therapeutics Inc South San Francisco, United StatesPOSITION SUMMARY · The Senior Director, Clinical Pharmacology and Pharmacometrics will work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pipeline molecules. The position will contribut ...
-
Structure Therapeutics South San Francisco, United StatesJob Description · Job DescriptionSalary: · POSITION SUMMARY · The Senior Director, Clinical Pharmacology and Pharmacometrics will work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pip ...
-
Recruits Lab (We're hiring) San Francisco, United StatesAre you ready to pioneer groundbreaking precision medicine therapies in the field of oncology? Our client, a leading clinical-stage precision medicine oncology company, is seeking a visionary · Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to join their ...
-
IDEAYA Biosciences, Inc. San Francisco, United StatesIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates ext ...
-
Amgen San Francisco, CA, United StatesCareer CategoryScientificJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology ...
-
Pharmacometrician
3 days ago
Pfizer South San Francisco, United States Full timeJOB SUMMARY · With guidance, contribute to the development of the model informed drug development (MIDD) plans for an assigned project in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners. · Conduc ...
-
Data Science Research Manager
2 weeks ago
University of California , San Francisco San Francisco, United StatesJob SummaryThe Savic Lab at UCSF is looking for a Data Science Research Manager who has the ability to manage multiple complex projects simultaneously. This leader receives assignments in the form of objectives and determines how to use available resources to meet schedules and g ...
-
Data Scientist
1 week ago
University of California San Francisco San Francisco, United StatesIntegrate quantitative approaches into drug discovery. · - Conduct modeling and simulation to inform drug discovery and translation of drug properties. · - Communicate quantitative data, both internally and in the scientific community. · - Provide scientific leadership to researc ...
-
Director, Quantitative Pharmacology
3 weeks ago
Denali Therapeutics South San Francisco, United StatesDenali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. The Company is seeking to hire a Director, Quantitative Pharmacology within the Quant ...
-
Director, Clinical Pharmacology
1 week ago
AbbVie South San Francisco, United States· Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic a ...
-
Director, Clinical Pharmacology
2 days ago
AbbVie South San Francisco, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
-
Associate Clinical Pharmacology
5 days ago
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · The Associate Clinical Pharmacology and Pharmacometrics Director has strong scientific, technical and leadership skills to contribute to development and implementation of clinical pharmacology and modeling & simulation strategies to advance drug candidate ...
-
Clinical Pharmacology
3 days ago
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · The Clinical Pharmacology & Pharmacometrics Director has strong sceintific, technical and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of the develop ...
-
Director, Clinical Pharmacology
6 days ago
AbbVie South San Francisco, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
-
Principal Scientist, Pharmacology
3 weeks ago
4D Molecular Therapeutics Inc. Emeryville, United StatesGENERAL ROLE DESCRIPTION: · The Principal Scientist Pharmacology role will be in the Biomarkers & Immunology group. The group performs pharmacokinetic (PK) evaluations, pharmacodynamic (PD) biomarker measurements, immunogenicity risk assessments, and exploratory clinical research ...
-
Senior Director, Clinical Pharmacology
3 weeks ago
BioSpace South San Francisco, United StatesJob Details · The Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmac ...
-
Senior Director, Clinical Pharmacology
4 days ago
Maze Therapeutics South San Francisco, United StatesThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
-
Senior Director, Clinical Pharmacology
2 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
Director, Quantitative Pharmacology and Pharmacometrics - San Francisco, United States - Merck
Description
Job Description
Role and Responsibilities:
We are seeking an experienced talented scientist to join the
Quantitative Pharmacology and
Pharmacometrics -
Immune/Oncology
(QP2-IO) team in the role of Director.
QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.
Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development.
As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities.
They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership and communication skills.They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.
Primary Responsibilities:
Minimum education required:
, with at least four years of pharmaceutical drug development experience relating to:
PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.
Required Experience:
NOTICE
FOR
INTERNAL
APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE $)
Current Contingent Workers apply HERE $)
US and
Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
For more information about personal rights under the U.S.Equal Opportunity Employment laws, visit:
EEOC Know Your Rights \_EEOC\_KnowYourRights\_10\)
EEOC GINA Supplement
Pay Transparency Nondiscrimination \_%20English\)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts )
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S.
will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$181, $285,800.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Required Skills:
Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management
Preferred Skills:
Job Posting End Date:
06/30/2024
A job posting is effective until 11:59:59PM on the day
BEFORE
the listed job posting end date. Please ensure you apply to a job posting no later than the day
BEFORE
the job posting end date.
Job Posting End Date:
06/30/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R277875
&v=024){kind=logo}
