Hiring company: Merck
Job Description
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Senior Principal Scientist, Quantitative Pharmacology and Pharmacometrics - Immune-Oncology (QP2-IO)
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. We are recognized as a leader in immune-oncology (IO) and vaccines discovery and development. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our company is on a quest for cures and is committed to be the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our company's Research Laboratories is a true scientific research facility of tomorrow and will take our company’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
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 Senior Principal Scientist. 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 (preclinical drug candidate) stage to registration. Senior Principal Scientists are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Senior Principal Scientists 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:
- Serving as an expert representative for QP2 -IO on Oncology development teams
- Framing critical drug development questions for optimizing model-based developments
- Developing and executing translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, comparator modeling and other model-based analyses
- 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 area, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2 at regulatory meetings
- Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.
Required:
- Demonstrated impactful experience with applications of pharmacometric methods in Oncology area
- Ph.D., PharmD or equivalent degree with at least ten years of experience / educational background relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.
- Master or equivalent degree with at least thirteen years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
- Experience in IND, NDA and other submissions to global regulatory agencies in Oncology area
- Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
- Proficiency in R, NONMEM or other similar programing language
- Professional working proficiency in written and verbal communication
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado
Click here to request this role’s pay range.
DATA2020
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. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
Pay Transparency Nondiscrimination
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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1