What are the responsibilities and job description for the Principal Clinical Pharmacologist position at BioSpace?
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We are looking for a Principal Scientist, Clinical Pharmacology in our Pharmacometrics (PMx) group. The position will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP) in the General Medicine (GM) group. This person will represent Clinical Pharmacology on project teams to provide strategic and scientific expertise to support new and on-going GM clinical programs. This individual is expected to provide significant contributions to PMx deliverables for multiple programs to support the strategies for each program. In addition, this person will prospectively contribute to longer-term development strategies executed over the course of multiple non-clinical experiments, clinical studies and PMx analyses. This person conducts or otherwise oversees the development of PMx analysis plans.
When & Where
Work Location: Tarrytown, NY, Warren, NJ or Cambridge, MA
Work model/flexibility: 4 days per week on site
Discover Your Role
Develop and maintain comprehensive strategic CP development plans for assigned programs with SGD supervision
Provide CP subject matter expertise and presentations to the Clinical Study Team/ Development Team and Senior Management/Governance meetings with SGD supervision
Collaborate and assist the Pre-clinical PK/PD Team and research teams to characterize preclinical PK/PD for prediction human PK/PD to accelerate clinical studies and achieve business goals
Assist in drafting and finalization of clinical study protocols and study analysis plans as well as draft, finalize, and/or review clinical pharmacology reports
Collaborate with the Medical Writing Team to incorporate PK/PD sections into clinical study reports
Provide CP support of regulatory documents, communications, and presentations (eg, IND, health authority queries, preparation of BLA summary sections, addressing review inquiries) with SGD supervision
Represent CP at pre-IND, Type C, preBLA, and other health authority meetings with SGD supervision
Work closely with Quantitative Pharmacology to develop quantitative strategies and to deliver analyses and technical reports to support strategic development plans
Actively publish work in scientific literature
This Role Requires
PhD (example Pharmacometrics, Biology, Pharmacology, Engineering), PharmD, MD
6 years of experience in clinical pharmacology
Strong communications skills to actively engage colleagues cross-functionally at all levels of the organization
Innovative and flexible mindset, keen scientific interest and solid science background are required.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$150,500.00 - $245,500.00
We are looking for a Principal Scientist, Clinical Pharmacology in our Pharmacometrics (PMx) group. The position will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP) in the General Medicine (GM) group. This person will represent Clinical Pharmacology on project teams to provide strategic and scientific expertise to support new and on-going GM clinical programs. This individual is expected to provide significant contributions to PMx deliverables for multiple programs to support the strategies for each program. In addition, this person will prospectively contribute to longer-term development strategies executed over the course of multiple non-clinical experiments, clinical studies and PMx analyses. This person conducts or otherwise oversees the development of PMx analysis plans.
When & Where
Work Location: Tarrytown, NY, Warren, NJ or Cambridge, MA
Work model/flexibility: 4 days per week on site
Discover Your Role
Develop and maintain comprehensive strategic CP development plans for assigned programs with SGD supervision
Provide CP subject matter expertise and presentations to the Clinical Study Team/ Development Team and Senior Management/Governance meetings with SGD supervision
Collaborate and assist the Pre-clinical PK/PD Team and research teams to characterize preclinical PK/PD for prediction human PK/PD to accelerate clinical studies and achieve business goals
Assist in drafting and finalization of clinical study protocols and study analysis plans as well as draft, finalize, and/or review clinical pharmacology reports
Collaborate with the Medical Writing Team to incorporate PK/PD sections into clinical study reports
Provide CP support of regulatory documents, communications, and presentations (eg, IND, health authority queries, preparation of BLA summary sections, addressing review inquiries) with SGD supervision
Represent CP at pre-IND, Type C, preBLA, and other health authority meetings with SGD supervision
Work closely with Quantitative Pharmacology to develop quantitative strategies and to deliver analyses and technical reports to support strategic development plans
Actively publish work in scientific literature
This Role Requires
PhD (example Pharmacometrics, Biology, Pharmacology, Engineering), PharmD, MD
6 years of experience in clinical pharmacology
Strong communications skills to actively engage colleagues cross-functionally at all levels of the organization
Innovative and flexible mindset, keen scientific interest and solid science background are required.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$150,500.00 - $245,500.00
Salary : $150,500 - $245,500