ON BEHALF OF MY CLIENT, WE ARE ASSISTING WITH THE ROLE OF DIRECTOR,
CLINICAL PHARMACOLOGY. AS DIRECTOR, WITHIN THE CLINICAL PHARMACOLOGY
GROUP YOU WILL HAVE ULTIMATE RESPONSIBILITY AND ACCOUNTABILITY FOR
CLINICAL PHARMACOLOGY PROGRAMS IN THE AREA OF HIV AND EMERGING VIRAL
INFECTIONS.
As a member of the Clinical Pharmacology team you will have
unparalleled opportunity to be involved with every aspect of the
product development process, from first-in human through approval,
including post-marketing activities. In this role, you will have the
advantage of providing input into a breadth of products within and
across your area of responsibility. We seek to provide a fun and
rewarding career and a continuous learning experience.
Your tasks and responsibilities will include;
Leading clinical pharmacology studies of the highest complexity
Providing strategic leadership and demonstrating accountability for
the clinical pharmacology programs supporting Phase **Apply on the
website** clinical development for development compounds in your
therapeutic area(s)
Developing and implementing new clinical pharmacology tools and
technologies to drive smarter drug development for programs.
Representing the department and providing subject matter expertise on
cross-functional project teams
Developing and maintaining collaborative working relationship with
colleagues within and outside the department
Supervising, developing and mentoring junior level scientists, both
direct reports and via matrix structure in clinical pharmacology teams
Authoring/reviewing/approving clinical protocols, analysis plans,
study reports and regulatory submissions
Developing high quality clinical pharmacology plans and content for
global regulatory submissions, including INDs, IBs, NDAs, MAAs and
paediatric plans
Maintaining and establishing relationships and agreements with
contract vendors
Evaluating departmental and broader organizational SOPs as fit for
purpose, in compliance with current scientific standards and
regulatory requirements
Ensuring adherence to agreed timelines and budgets to insure prompt
and accurate execution of deliverables from clinical pharmacology
studies and programs
Understanding the impact of decisions and actions on the business and
consulting with colleagues and management as applicable
Participating in and collaborating with individuals from across the
business in special projects
Developing and presenting training within and outside the department
Specific education, experience and skills required for this role;
Extensive experience and a, PhD, PharmD or MD degree with emphasis in
clinical pharmacology, pharmacokinetics or a related scientific
discipline
In-depth knowledge of pharmacokinetic and other analysis software
programs (e.g. WinNonlin, GraphPad, etc.)
Thorough knowledge of current and emerging scientific standards
regulatory requirements for assigned territories
Excellent written and oral communication skills and ability to convey
complex technical information clearly
Confidence and ability to present to and influence senior leaders
Ability to critically analyze problems and provide creative solutions
Confidence and discipline to work autonomously
Genuine curiosity and drive to ask questions looking for the why of
every project
Desire to strive for continuous improvement
For full details on this opportunity contact Tina ?or email (Please
contact us using the "Apply for this Job Posting" box below)
Thornshaw Scientific is a division of the CPL group of companies..com
JOB DESCRIPTION
ON BEHALF OF MY CLIENT, WE ARE ASSISTING WITH THE ROLE OF DIRECTOR,
CLINICAL PHARMACOLOGY. AS DIRECTOR, WITHIN THE CLINICAL PHARMACOLOGY
GROUP YOU WILL HAVE ULTIMATE RESPONSIBILITY AND ACCOUNTABILITY FOR
CLINICAL PHARMACOLOGY PROGRAMS IN THE AREA OF HIV AND EMERGING VIRAL
INFECTIONS.
As a member of the Clinical Pharmacology team you will have
unparalleled opportunity to be involved with every aspect of the
product development process, from first-in human through approval,
including post-marketing activities. In this role, you will have the
advantage of providing input into a breadth of products within and
across your area of responsibility. We seek to provide a fun and
rewarding career and a continuous learning experience.
Your tasks and responsibilities will include;
Leading clinical pharmacology studies of the highest complexity
Providing strategic leadership and demonstrating accountability for
the clinical pharmacology programs supporting Phase **Apply on the
website** clinical development for development compounds in your
therapeutic area(s)
Developing and implementing new clinical pharmacology tools and
technologies to drive smarter drug development for programs.
Representing the department and providing subject matter expertise on
cross-functional project teams
Developing and maintaining collaborative working relationship with
colleagues within and outside the department
Supervising, developing and mentoring junior level scientists, both
direct reports and via matrix structure in clinical pharmacology teams
Authoring/reviewing/approving clinical protocols, analysis plans,
study reports and regulatory submissions
Developing high quality clinical pharmacology plans and content for
global regulatory submissions, including INDs, IBs, NDAs, MAAs and
paediatric plans
Maintaining and establishing relationships and agreements with
contract vendors
Evaluating departmental and broader organizational SOPs as fit for
purpose, in compliance with current scientific standards and
regulatory requirements
Ensuring adherence to agreed timelines and budgets to insure prompt
and accurate execution of deliverables from clinical pharmacology
studies and programs
Understanding the impact of decisions and actions on the business and
consulting with colleagues and management as applicable
Participating in and collaborating with individuals from across the
business in special projects
Developing and presenting training within and outside the department
Specific education, experience and skills required for this role;
Extensive experience and a, PhD, PharmD or MD degree with emphasis in
clinical pharmacology, pharmacokinetics or a related scientific
discipline
In-depth knowledge of pharmacokinetic and other analysis software
programs (e.g. WinNonlin, GraphPad, etc.)
Thorough knowledge of current and emerging scientific standards
regulatory requirements for assigned territories
Excellent written and oral communication skills and ability to convey
complex technical information clearly
Confidence and ability to present to and influence senior leaders
Ability to critically analyze problems and provide creative solutions
Confidence and discipline to work autonomously
Genuine curiosity and drive to ask questions looking for the why of
every project
Desire to strive for continuous improvement
For full details on this opportunity contact Tina ?or email (Please
contact us using the "Apply for this Job Posting" box below)
Thornshaw Scientific is a division of the CPL group of companies..com
We need : English (Good)
Type: Permanent
Payment:
Category: Others