Quantitative Clinical Pharmacology Lead
Make your mark for patientsWe are looking for a Quantitative Clinical Pharmacology Leadto join our Development Science team as part of our expanding new R&D HUB team, based in Cambridge, Massachusetts.
About the roleJoin our dynamic team in Cambridge, MA as a Clinical Pharmacology Lead and play a key role in shaping this expansion, while taking your expertise to the next level.
We are seeking a seasoned professional to develop and execute clinical pharmacology plans for our late-stage projects and contribute to our exciting early-stage pre-clinical studies, ensuring that our pre-clinical PoC studies support a smooth transition to the clinic.
This role gives you the opportunity to make a major impact on late-stage and early-stage projects.
Your primary responsibilities will include leadership of program-specific clinical pharmacology strategies, data interpretation and application to support asset progression through our rapidly growing portfolio of novel modalities and competitive targets.
Who you ll work withYou will be one of the senior Clinical Pharmacology experts in the US and will have the opportunity to work closely with CP colleagues across Europe, Asia and the US.
You will be part of the global Quantitative Discovery and Development Community as well as part of the local US Development Science Leadership Team.
Therefore, you are going to have a major impact on the evolution of the group by sharing your knowledge, locally and globally.
You will have the chance to represent the group externally by participating in international conferences to maintain and grow your network and expertise.
What you ll doThis includes regulatory submissions and beyond via characterizing PK and integrating knowledge in PK/PD /safety to select the right dose and dose regimen for the general population and subpopulations.
Provide expertise and know-how in designing and implementing clinical pharmacology strategy in clinical trials during all clinical phases from translation through to life-cycle management.
Interact with Regulatory Authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to clinical pharmacology and drug development.
Provide input on very early projects to further shorten the timelines to our patients.
Finding opportunities to develop as a matrix leader, driving the overall integrated strategy for the team as well as related to assigned projects.
Interested? For this role we re looking for the following education, experience, and skillsPh.
D.
, PharmD, or M.
D.
in pharmacokinetics, biopharmaceutics, clinical pharmacology, pharmacometrics discipline with a minimum of 10 years Pharma industry experience in a relevant roleMinimum of 5 years direct experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.
g.
INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a prerequisite.
Ability and willingness to work in a culturally diverse team, with colleagues from around the world.
Experience working on the development of small molecules, biologicsOfficial Salary Range / QCP Lead :
$218,790 to $255,255Official Salary Range / QCP Lead (Senior):
$262,350 to $306,075If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.
RANDATUCBAre you ready to go beyond to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About usUCB is a global biopharmaceutical company, focusing on neurology and immunology.
We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work for us?At UCB, we don t just complete tasks, we create value.
We aren t afraid to push forward, collaborate, and innovate to make our mark for patients.
We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.
We go beyond to create value for our patients, and always with a human focus, whether that s on our patients, our employees or our planet.
Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
Learn more about sustainability at UCB and how it is integrated into our business approach.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer.
We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Job SummaryJob number:
84367Date posted :
2023-03-28Profession:
Research & DevelopmentEmployment type:
Permanent.
Estimated Salary: $20 to $28 per hour based on qualifications.
About the roleJoin our dynamic team in Cambridge, MA as a Clinical Pharmacology Lead and play a key role in shaping this expansion, while taking your expertise to the next level.
We are seeking a seasoned professional to develop and execute clinical pharmacology plans for our late-stage projects and contribute to our exciting early-stage pre-clinical studies, ensuring that our pre-clinical PoC studies support a smooth transition to the clinic.
This role gives you the opportunity to make a major impact on late-stage and early-stage projects.
Your primary responsibilities will include leadership of program-specific clinical pharmacology strategies, data interpretation and application to support asset progression through our rapidly growing portfolio of novel modalities and competitive targets.
Who you ll work withYou will be one of the senior Clinical Pharmacology experts in the US and will have the opportunity to work closely with CP colleagues across Europe, Asia and the US.
You will be part of the global Quantitative Discovery and Development Community as well as part of the local US Development Science Leadership Team.
Therefore, you are going to have a major impact on the evolution of the group by sharing your knowledge, locally and globally.
You will have the chance to represent the group externally by participating in international conferences to maintain and grow your network and expertise.
What you ll doThis includes regulatory submissions and beyond via characterizing PK and integrating knowledge in PK/PD /safety to select the right dose and dose regimen for the general population and subpopulations.
Provide expertise and know-how in designing and implementing clinical pharmacology strategy in clinical trials during all clinical phases from translation through to life-cycle management.
Interact with Regulatory Authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to clinical pharmacology and drug development.
Provide input on very early projects to further shorten the timelines to our patients.
Finding opportunities to develop as a matrix leader, driving the overall integrated strategy for the team as well as related to assigned projects.
Interested? For this role we re looking for the following education, experience, and skillsPh.
D.
, PharmD, or M.
D.
in pharmacokinetics, biopharmaceutics, clinical pharmacology, pharmacometrics discipline with a minimum of 10 years Pharma industry experience in a relevant roleMinimum of 5 years direct experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.
g.
INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a prerequisite.
Ability and willingness to work in a culturally diverse team, with colleagues from around the world.
Experience working on the development of small molecules, biologicsOfficial Salary Range / QCP Lead :
$218,790 to $255,255Official Salary Range / QCP Lead (Senior):
$262,350 to $306,075If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.
RANDATUCBAre you ready to go beyond to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About usUCB is a global biopharmaceutical company, focusing on neurology and immunology.
We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work for us?At UCB, we don t just complete tasks, we create value.
We aren t afraid to push forward, collaborate, and innovate to make our mark for patients.
We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.
We go beyond to create value for our patients, and always with a human focus, whether that s on our patients, our employees or our planet.
Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
Learn more about sustainability at UCB and how it is integrated into our business approach.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer.
We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Job SummaryJob number:
84367Date posted :
2023-03-28Profession:
Research & DevelopmentEmployment type:
Permanent.
Estimated Salary: $20 to $28 per hour based on qualifications.
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