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Director of Clinical Affairs
at CaridianBCT in Lakewood, CO
ORGANIZATIONAL OVERVIEW:
CaridianBCT is a global leader in the blood bank and transfusion
medicine industry, investing in research and development focused on
enhancing blood quality, safety and supply. It provides technology,
products and services to blood centers, hospitals, and scientific,
clinical and biotech researchers. Driven by its vision, For Better
Blood and Better Lives, CaridianBCT's mission is to improve lives
through innovation, quality and services delivered by our people,
products and processes in blood component technologies.
It is the largest medical device manufacturer headquartered in
Colorado. Headquartered in Lakewood, Colorado (just west of Denver),
CaridianBCT employs nearly 2,500 people in 32 countries and has sales
in more than 96 countries. It has production facilities in the U.S.
and in Northern Ireland. The company is privately held.
CaridianBCT specializes in four business areas:
Automated Collections - CaridianBCT delivers products and services
that enhance blood quality, safety, supply and efficiency through
automating the collection of leukoreduced red cells, platelets and
plasma.
Whole Blood Processes - CaridianBCT provides technology to automate
blood component laboratories' manufacturing processes of whole blood.
Pathogen Reduction Technology - CaridianBCT's Mirasol® Pathogen
Reduction Technology is a riboflavin and light-based technology
designed to reduce disease-causing viruses, bacteria, and parasites
and to neutralize white blood cells within all blood components. It
has received a CE mark for use with plasma platelets and is available
for sale in countries where the CE mark is accepted. It is not,
however, available for sale in the United States.
Therapeutic Systems - CaridianBCT delivers a range of technologies
that enable advances in medicine through innovations in stem cell and
white blood cell collections, cell and tissue processing, and
therapeutic apheresis. Therapeutic apheresis is a process removing
disease mediators or disease-carrying media from the patient. Cell
therapies is the collection of blood cells, including peripheral
blood stem cells and monocytes, from a patient or donor's blood
stream, then processing and re-infusing as a part of various
treatments.
CaridianBCT's key products and systems, Trima Accel®, COBE® Spectra,
Spectra Optia®, Elutra® Cell Separation, Vista® Information, Orbisac
and COBE® 2991 Cell Processor, as well as our Mirasol PRT and Atreus®
Whole Blood Processing are widely recognized as delivering the
highest value and quality to customers around the world.
You can learn more about the company on its website at
( www.caridianbct.com/ ) www.caridianbct.com.
WORKING JOB TITLE: Director CLINICAL AFFAIRS - PRT
BASIC FUNCTION:
Working with minimum direction, develops objectives, plans and
protocols for clinical trials to achieve end results that support
CaridianBCT Biotechnologies' business strategies and goals. The
Director Clinical Affairs has overall responsibility to conduct,
coordinate and manage clinical trials; clinical studies, national
validation studies, post market surveillance and hemovigilance
studies.
Assists in managing regulatory aspects of business by applying a
thorough understanding of regulatory/ standards requirements to one
or more areas of expertise such as international medical device
regulations and standards, product reimbursement, product liability
and standards.
MINIMUM KNOWLEDGE REQUIRED/QUALIFICATIONS:
Knowledge necessary to perform in this position is generally
acquired through, at a minimum, Bachelor's degree in nursing
or biological sciences or in a related scientific discipline,
or equivalent and at least ten years experience in conducting
clinical trials in the medical device field. An advanced
degree such as a degree in medicine is preferred. Extensive
experience in managing all phases of multi-center clinical
trials either medical devised or drugs. International clinical
trial experience is a requirement.
Thorough understanding of clinical trial reporting
requirements.
Thorough knowledge of the physiology and clinical practice of
the relevant therapies.
Knowledge of medical statistics and experimental design.
Broad knowledge of clinical methods, both laboratory and
therapy delivery related.
Extensive knowledge of clinical study (GCP) and good working
knowledge of regulatory requirements.
In-depth technical knowledge of European and international
medical device regulations, standards, policies and guidance
documents. Working knowledge of and ability to prepare
regulatory documentation.
Excellent organizational, written and oral communication
skills and proven ability to establish working relationships
with all levels of clinical/technical/marketing people both in
a corporate, clinical and academic setting.
Demonstrated self-directed and able to work independently.
Demonstrated and effective leadership, management and
cross-functional team skills.
Demonstrated strategic planning skills.
Demonstrated positive and proactive approach to identification
and definition of problems and the development and
implementation of solutions. A constructive and relentless
pursuit of solutions, and motivates others to do the same.
A high level of initiative, as well as willingness to take
ownership and accept responsibility for actions and decisions.
Experience managing staff.
Previous employment with small and large companies preferred.
Demonstrated interpersonal skills and the ability to represent
the business in contacts with those both internal and external
to the organization. Demonstrated ability to interact with
diplomacy and tact while maintaining appropriate assertiveness
and persistence.
Ability to travel extensively. Ability to coordinate and
manage clinical trial activities on a global basis.
Industry experience in representing a company during early
collaboration meetings with the regulatory authorities in
Europe and/or the Food and Drug Administration staff and
conferring with those regulatory authorities regarding pending
and proposed submissions.
Be highly adaptive.
RESPONSIBILITIES:
Assumes responsibility for and lead all clinical trials.
Provides clinical and limited regulatory advice where
experience supports this to executive team. Be an active
member of the Executive Management Team participating in all
major strategic and tactical decisions and initiatives.
Reviews proposals for clinical studies to ensure that they
meet regulatory requirements, corporate objectives and company
SOPs. Makes recommendations to the Executive Management Team
concerning whether proposal should be approved or not.
Leads activities relating to negotiating clinical research
organization agreements, investigator agreements and clinical
site selection.
Organizes and manages external groups participating in
clinical trials, including clinical research organization,
principal investigator groups and data safety monitoring
boards.
Responsible for working with the scientific and marketing
functions to develop design of pre-clinical and clinical
studies of new products and protocols to support product
claims and regulatory submissions.
Responsibility for planning, coordinating, monitoring and
reporting on clinical studies conducted for the business. Also
is responsible for identification of appropriate resource
requirement and their qualifications.
Ensures adherence to protocols and company general policies
regarding clinical studies.
Establishes study/trial priorities.
Maintains state of the art knowledge of the requirements for
proper conduct of clinical studies/trials and the requirements
of both regulatory and internal for international and domestic
applications.
Updates departmental procedures as they relate to clinical
trials, etc. based on any changes in regulatory requirements
or company policies.
Prepares reports/documentation for regulatory submissions
derived from studies managed.
Reviews study reports to determine that study/trial objectives
are met and that the results are valid from a clinical
perspective.
Keeps the Executive Management Team informed as to the
results, as well as any observations that may be of a clinical
or product performance import.
Uses a broad base of knowledge and understanding of regulatory
requirements.
Identifies areas where the business can effect improvements
and establishes operating policies with direction.
Excellent writing and presentation skills.
Budgeting experience.
Reporting Relationship:
This position will report directly to the Senior Vice
President/General Manager at CaridianBCT Biotechnologies, LLC.
We are proud to be an Equal Opportunity/ Affirmative Action Employer.
We maintain a drug-free workplace and perform pre-employment
substance abuse testing and background verification checks. For more
information about CaridianBCT visit our website
( www.caridianbct.com/ ) www.caridianbct.com.
Requirements
Leading Clinical Trials
CaridianBCT is a global leader in the blood bank and transfusion
medicine industry, investing in research and development focused on
enhancing blood quality, safety and supply. It provides technology,
products and services to blood centers, hospitals, and scientific,
clinical and biotech researchers. Driven by its vision, For Better
Blood and Better Lives, CaridianBCT's mission is to improve lives
through innovation, quality and services delivered by our people,
products and processes in blood component technologies.
It is the largest medical device manufacturer headquartered in
Colorado. Headquartered in Lakewood, Colorado (just west of Denver),
CaridianBCT employs nearly 2,500 people in 32 countries and has sales
in more than 96 countries. It has production facilities in the U.S.
and in Northern Ireland. The company is privately held.
CaridianBCT specializes in four business areas:
Automated Collections - CaridianBCT delivers products and services
that enhance blood quality, safety, supply and efficiency through
automating the collection of leukoreduced red cells, platelets and
plasma.
Whole Blood Processes - CaridianBCT provides technology to automate
blood component laboratories' manufacturing processes of whole blood.
Pathogen Reduction Technology - CaridianBCT's Mirasol® Pathogen
Reduction Technology is a riboflavin and light-based technology
designed to reduce disease-causing viruses, bacteria, and parasites
and to neutralize white blood cells within all blood components. It
has received a CE mark for use with plasma platelets and is available
for sale in countries where the CE mark is accepted. It is not,
however, available for sale in the United States.
Therapeutic Systems - CaridianBCT delivers a range of technologies
that enable advances in medicine through innovations in stem cell and
white blood cell collections, cell and tissue processing, and
therapeutic apheresis. Therapeutic apheresis is a process removing
disease mediators or disease-carrying media from the patient. Cell
therapies is the collection of blood cells, including peripheral
blood stem cells and monocytes, from a patient or donor's blood
stream, then processing and re-infusing as a part of various
treatments.
CaridianBCT's key products and systems, Trima Accel®, COBE® Spectra,
Spectra Optia®, Elutra® Cell Separation, Vista® Information, Orbisac
and COBE® 2991 Cell Processor, as well as our Mirasol PRT and Atreus®
Whole Blood Processing are widely recognized as delivering the
highest value and quality to customers around the world.
You can learn more about the company on its website at
( www.caridianbct.com/ ) www.caridianbct.com.
WORKING JOB TITLE: Director CLINICAL AFFAIRS - PRT
BASIC FUNCTION:
Working with minimum direction, develops objectives, plans and
protocols for clinical trials to achieve end results that support
CaridianBCT Biotechnologies' business strategies and goals. The
Director Clinical Affairs has overall responsibility to conduct,
coordinate and manage clinical trials; clinical studies, national
validation studies, post market surveillance and hemovigilance
studies.
Assists in managing regulatory aspects of business by applying a
thorough understanding of regulatory/ standards requirements to one
or more areas of expertise such as international medical device
regulations and standards, product reimbursement, product liability
and standards.
MINIMUM KNOWLEDGE REQUIRED/QUALIFICATIONS:
Knowledge necessary to perform in this position is generally
acquired through, at a minimum, Bachelor's degree in nursing
or biological sciences or in a related scientific discipline,
or equivalent and at least ten years experience in conducting
clinical trials in the medical device field. An advanced
degree such as a degree in medicine is preferred. Extensive
experience in managing all phases of multi-center clinical
trials either medical devised or drugs. International clinical
trial experience is a requirement.
Thorough understanding of clinical trial reporting
requirements.
Thorough knowledge of the physiology and clinical practice of
the relevant therapies.
Knowledge of medical statistics and experimental design.
Broad knowledge of clinical methods, both laboratory and
therapy delivery related.
Extensive knowledge of clinical study (GCP) and good working
knowledge of regulatory requirements.
In-depth technical knowledge of European and international
medical device regulations, standards, policies and guidance
documents. Working knowledge of and ability to prepare
regulatory documentation.
Excellent organizational, written and oral communication
skills and proven ability to establish working relationships
with all levels of clinical/technical/marketing people both in
a corporate, clinical and academic setting.
Demonstrated self-directed and able to work independently.
Demonstrated and effective leadership, management and
cross-functional team skills.
Demonstrated strategic planning skills.
Demonstrated positive and proactive approach to identification
and definition of problems and the development and
implementation of solutions. A constructive and relentless
pursuit of solutions, and motivates others to do the same.
A high level of initiative, as well as willingness to take
ownership and accept responsibility for actions and decisions.
Experience managing staff.
Previous employment with small and large companies preferred.
Demonstrated interpersonal skills and the ability to represent
the business in contacts with those both internal and external
to the organization. Demonstrated ability to interact with
diplomacy and tact while maintaining appropriate assertiveness
and persistence.
Ability to travel extensively. Ability to coordinate and
manage clinical trial activities on a global basis.
Industry experience in representing a company during early
collaboration meetings with the regulatory authorities in
Europe and/or the Food and Drug Administration staff and
conferring with those regulatory authorities regarding pending
and proposed submissions.
Be highly adaptive.
RESPONSIBILITIES:
Assumes responsibility for and lead all clinical trials.
Provides clinical and limited regulatory advice where
experience supports this to executive team. Be an active
member of the Executive Management Team participating in all
major strategic and tactical decisions and initiatives.
Reviews proposals for clinical studies to ensure that they
meet regulatory requirements, corporate objectives and company
SOPs. Makes recommendations to the Executive Management Team
concerning whether proposal should be approved or not.
Leads activities relating to negotiating clinical research
organization agreements, investigator agreements and clinical
site selection.
Organizes and manages external groups participating in
clinical trials, including clinical research organization,
principal investigator groups and data safety monitoring
boards.
Responsible for working with the scientific and marketing
functions to develop design of pre-clinical and clinical
studies of new products and protocols to support product
claims and regulatory submissions.
Responsibility for planning, coordinating, monitoring and
reporting on clinical studies conducted for the business. Also
is responsible for identification of appropriate resource
requirement and their qualifications.
Ensures adherence to protocols and company general policies
regarding clinical studies.
Establishes study/trial priorities.
Maintains state of the art knowledge of the requirements for
proper conduct of clinical studies/trials and the requirements
of both regulatory and internal for international and domestic
applications.
Updates departmental procedures as they relate to clinical
trials, etc. based on any changes in regulatory requirements
or company policies.
Prepares reports/documentation for regulatory submissions
derived from studies managed.
Reviews study reports to determine that study/trial objectives
are met and that the results are valid from a clinical
perspective.
Keeps the Executive Management Team informed as to the
results, as well as any observations that may be of a clinical
or product performance import.
Uses a broad base of knowledge and understanding of regulatory
requirements.
Identifies areas where the business can effect improvements
and establishes operating policies with direction.
Excellent writing and presentation skills.
Budgeting experience.
Reporting Relationship:
This position will report directly to the Senior Vice
President/General Manager at CaridianBCT Biotechnologies, LLC.
We are proud to be an Equal Opportunity/ Affirmative Action Employer.
We maintain a drug-free workplace and perform pre-employment
substance abuse testing and background verification checks. For more
information about CaridianBCT visit our website
( www.caridianbct.com/ ) www.caridianbct.com.
Requirements
Leading Clinical Trials
Published at 11-11-2008
College ad viewed: 245 times
College ad viewed: 245 times