What are the responsibilities and job description for the Executive Director, Clinical Development, - Thousand Oaks CA position at VetJobs?
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
What you will do
Let’s do this. Let’s change the world. In this vital role as an Executive Director, you will play an important role in scientific strategy and planning and execution for all aspects of clinical drug development across Amgen’s clinical programs.
This Executive Director within Clinical Development will be involved with the full scope of the General Medicine disease clinical drug development activities from the design and execution of Phase 2 through Phase 4 studies.
They will serve as the principal representative for global development within the General Medicine therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.
The General Medicine portfolio encompasses a broad array of therapeutic areas that include cardiovascular disease and prevention, renal disease, neurological, endocrine disease including bone diseases, among others. It does not include oncology and inflammatory diseases.
This role will include global development leadership of one or more assets within the portfolio and require people management activities. The position will work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as well as the overall product strategy.
The Executive Director will report into the Vice President, Global Clinical Development General Medicine.
Responsibilities
Serve as the global development leader for a product team with an enterprise mindset
Develop the clinical strategy for the product including indications and sequencing
Partner with clinical operations to deliver the studies
Manage clinical development medical and/or scientific directors working on various clinical trials for the product
Provide adequate oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profile
Provide adequate oversight into the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleagues
Drive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activities
Review, interpret and present clinical data to internal and external stakeholders
Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents
Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations
Maintain up-to-date knowledge of scientific and clinical published literature
Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development plan
Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants
Provide input/review study start up documentation, e.g., CRF design
Attend and provide clinical support for investigator and steering committee meetings
Participate in due diligence and business development activities as needed
Always operate within Compliance Guidelines
Provide medical monitoring oversight for clinical trials as required
Auto req ID
469327BR
Minimum Education Required
High School/GED
Job_Category
Manufacturing
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications.
Basic Qualifications
MD or DO from an accredited medical school AND
Five (5) years of industry or academic research AND
Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
PhD, or MBBS plus accredited residency in relevant sub-specialty, board certified or equivalent
Ten (10) or more years in biopharmaceutical sponsored clinical research is desirable
Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable
Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Ability to analyze and interpret complex datasets
Exercises initiative in meeting goals and drives innovation in projects
They will also embody the Amgen leadership attributes which are:
Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The annual base salary range for this opportunity in the U.S. is $361,379 - $414,638
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
What you will do
Let’s do this. Let’s change the world. In this vital role as an Executive Director, you will play an important role in scientific strategy and planning and execution for all aspects of clinical drug development across Amgen’s clinical programs.
This Executive Director within Clinical Development will be involved with the full scope of the General Medicine disease clinical drug development activities from the design and execution of Phase 2 through Phase 4 studies.
They will serve as the principal representative for global development within the General Medicine therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.
The General Medicine portfolio encompasses a broad array of therapeutic areas that include cardiovascular disease and prevention, renal disease, neurological, endocrine disease including bone diseases, among others. It does not include oncology and inflammatory diseases.
This role will include global development leadership of one or more assets within the portfolio and require people management activities. The position will work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as well as the overall product strategy.
The Executive Director will report into the Vice President, Global Clinical Development General Medicine.
Responsibilities
Serve as the global development leader for a product team with an enterprise mindset
Develop the clinical strategy for the product including indications and sequencing
Partner with clinical operations to deliver the studies
Manage clinical development medical and/or scientific directors working on various clinical trials for the product
Provide adequate oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profile
Provide adequate oversight into the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleagues
Drive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activities
Review, interpret and present clinical data to internal and external stakeholders
Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents
Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations
Maintain up-to-date knowledge of scientific and clinical published literature
Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development plan
Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants
Provide input/review study start up documentation, e.g., CRF design
Attend and provide clinical support for investigator and steering committee meetings
Participate in due diligence and business development activities as needed
Always operate within Compliance Guidelines
Provide medical monitoring oversight for clinical trials as required
Auto req ID
469327BR
Minimum Education Required
High School/GED
Job_Category
Manufacturing
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications.
Basic Qualifications
MD or DO from an accredited medical school AND
Five (5) years of industry or academic research AND
Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
PhD, or MBBS plus accredited residency in relevant sub-specialty, board certified or equivalent
Ten (10) or more years in biopharmaceutical sponsored clinical research is desirable
Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable
Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Ability to analyze and interpret complex datasets
Exercises initiative in meeting goals and drives innovation in projects
They will also embody the Amgen leadership attributes which are:
Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The annual base salary range for this opportunity in the U.S. is $361,379 - $414,638
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000
Salary : $100,000