This job is archived
Ophthalmologist - Medical Director for Product Development/Clinical Trials/Research! Los Angeles!
Job Summary
Occupation
Physician
Specialty
Ophthalmology
Degree Required
MD/DO
Position Type
Permanent/Full-Time
Work Environment
Ambulatory Surgery Center (ASC)
Academic/Training Program
Hospital
Clinic/Private Practice
Location
Los Angeles, California, United States
Visa Sponsorship
No
Job Description
Last Update:
5/08/15
Take your career to the next level while living in Los Angeles!
Opportunity:
As the incoming Ophthalmologist, you’ll have the role of Medical Director for a company that is focused on product development, clinical trials and research for use in the field of cataract/refractive surgery. This position has strategic and tactical responsibility for medical aspects of clinical development activities within the clinical trials/research.
You’ll be key in establishing and approving human clinical trials, phases I to IV for assigned company products under development. This includes reporting, patient safety monitoring, principal internal consultant to quality, acting as liaison for business development, performing internal review of products and/or companies being considered for acquisition, and participating in activities related to the generation and dissemination of data supporting overall product scientific and business strategy. These activities will be strategically linked to the direction provided by the company and the regulatory process. You’ll also partner closely with R&D on internal development of existing portfolio and serve as the medical expert on all aspects of cataract/refractive surgery.
Core Job Responsibilities:
• Responsible for ensuring global strategic cross-functional alignment of post market studies
• Provides medical leadership and support in Quality meetings pertaining to product safety surveillance
• Provides medical expertise on Product Portfolio Committee to facilitate internal growth and development of new products and technology
• Represents the organization at global ophthalmology meetings to foster relationships, discuss ideas for post market studies, podium presentations and publications
• Assist in the design of clinical studies and development plans, from early translational development activities to mature product life cycle management strategies
• Participation in design and execution of clinical trial safety, product safety and risk management plans and routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable adverse events and serious adverse events
• Interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical research, R&D, statistics, regulatory, etc) as they relate to ongoing clinical or medical affairs projects
• Assists in scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
• Represents the company at external meetings including investigator meetings, scientific association meetings, etc
• Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with these requirements
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisors and symposia
• May assist with the scientific review, development and communication of investigator initiated studies
You’ll report to the Chief Medical Officer with global accountability and be accountable for ensuring patient safety. This is accomplished through accurate medical risk management activities in both product development and product surveillance and applies to marketed products and products under development, both in the US and internationally. You’ll also be accountable for achievement of both performance and financial goals for Medical Affairs and be accountable for Medical interactions with FDA or other regulatory agencies regarding product development, clinical research, product safety or new product registration.
You’ll function independently to conceive of, design, execute and analyze results of clinical trials and other research modalities. As well as function with autonomy as an integral member and subject matter expert on the division portfolio committee, participating in product concept and development, implementation and testing, culminating in product launch in support of strategic division goals.
This position is responsible for continuous improvement initiatives and leverages new appropriate technology consistent with regulatory and compliance strategies; develops and assures appropriate training and education programs are in place to support medical education of internal clinical and engineering professionals. You’ll use your medical judgment to make decisions as they relate to development of requirements for new products, clinical trial design, data analysis and presentation, patient or user safety issues, including but not limited to evaluation and assessment of potential adverse and serious adverse events, complaints, etc.
Minimum Experience/Training Required:
The successful candidate will have be a MD with an Ophthalmology Residency and Board Certification required, a fellowship in corneal or cataract surgery is preferred.
• 5 years minimum medical affairs or clinical trial experience in the ophthalmic industry or academia or equivalent, which may include one or more of the following:
* Participation as an investigator in industry sponsored trials
* Demonstrated strategic skills and previous management experience
* Experience designing trials, writing protocols, medical reports or peer review publications
* Experience designing clinical programs and strategies
* Experience in working with FDA on product development and/or approvals
* Excellent written and verbal communication skills
* General knowledge of biostatistics as it is applied to clinical data analysis
• Medical background, with ophthalmic surgical experience
• Ability to interact externally and internally to support global business strategy
• General knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developing and implementing clinical trials
• Must possess excellent oral and written English communication skills
• Ability to make clinical decisions on patient safety
• Be known as a person who has high integrity, sound character and a tremendous work ethic
• Ability to travel 50% of the time.
Compensation & Location:
In return for your training and expertise, this opportunity is offering a lucrative compensation package with a base salary, bonus eligibility and full benefits. The hiring organization wishes to discuss the details of the package on an individual basis with physicians as so much will hinge on your background as well as your personal needs. You’ll also benefit from living, working and, especially, playing in fabulous Los Angeles California! [Register to View] Need we say more?!
Contact:
Please contact Talent Medical Staffing for further details and to submit your CV. Sending your CV is the quickest way to connect with us (kept confidential). Contact us directly at [Register to View] or [Register to View] . Feel free to speak with any of our agents or leave a message on the mainline and we’ll return your call ASAP. You can also check out some of our other jobs online at [Register to View] We look forward to working with you!
Opportunity:
As the incoming Ophthalmologist, you’ll have the role of Medical Director for a company that is focused on product development, clinical trials and research for use in the field of cataract/refractive surgery. This position has strategic and tactical responsibility for medical aspects of clinical development activities within the clinical trials/research.
You’ll be key in establishing and approving human clinical trials, phases I to IV for assigned company products under development. This includes reporting, patient safety monitoring, principal internal consultant to quality, acting as liaison for business development, performing internal review of products and/or companies being considered for acquisition, and participating in activities related to the generation and dissemination of data supporting overall product scientific and business strategy. These activities will be strategically linked to the direction provided by the company and the regulatory process. You’ll also partner closely with R&D on internal development of existing portfolio and serve as the medical expert on all aspects of cataract/refractive surgery.
Core Job Responsibilities:
• Responsible for ensuring global strategic cross-functional alignment of post market studies
• Provides medical leadership and support in Quality meetings pertaining to product safety surveillance
• Provides medical expertise on Product Portfolio Committee to facilitate internal growth and development of new products and technology
• Represents the organization at global ophthalmology meetings to foster relationships, discuss ideas for post market studies, podium presentations and publications
• Assist in the design of clinical studies and development plans, from early translational development activities to mature product life cycle management strategies
• Participation in design and execution of clinical trial safety, product safety and risk management plans and routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable adverse events and serious adverse events
• Interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical research, R&D, statistics, regulatory, etc) as they relate to ongoing clinical or medical affairs projects
• Assists in scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
• Represents the company at external meetings including investigator meetings, scientific association meetings, etc
• Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with these requirements
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisors and symposia
• May assist with the scientific review, development and communication of investigator initiated studies
You’ll report to the Chief Medical Officer with global accountability and be accountable for ensuring patient safety. This is accomplished through accurate medical risk management activities in both product development and product surveillance and applies to marketed products and products under development, both in the US and internationally. You’ll also be accountable for achievement of both performance and financial goals for Medical Affairs and be accountable for Medical interactions with FDA or other regulatory agencies regarding product development, clinical research, product safety or new product registration.
You’ll function independently to conceive of, design, execute and analyze results of clinical trials and other research modalities. As well as function with autonomy as an integral member and subject matter expert on the division portfolio committee, participating in product concept and development, implementation and testing, culminating in product launch in support of strategic division goals.
This position is responsible for continuous improvement initiatives and leverages new appropriate technology consistent with regulatory and compliance strategies; develops and assures appropriate training and education programs are in place to support medical education of internal clinical and engineering professionals. You’ll use your medical judgment to make decisions as they relate to development of requirements for new products, clinical trial design, data analysis and presentation, patient or user safety issues, including but not limited to evaluation and assessment of potential adverse and serious adverse events, complaints, etc.
Minimum Experience/Training Required:
The successful candidate will have be a MD with an Ophthalmology Residency and Board Certification required, a fellowship in corneal or cataract surgery is preferred.
• 5 years minimum medical affairs or clinical trial experience in the ophthalmic industry or academia or equivalent, which may include one or more of the following:
* Participation as an investigator in industry sponsored trials
* Demonstrated strategic skills and previous management experience
* Experience designing trials, writing protocols, medical reports or peer review publications
* Experience designing clinical programs and strategies
* Experience in working with FDA on product development and/or approvals
* Excellent written and verbal communication skills
* General knowledge of biostatistics as it is applied to clinical data analysis
• Medical background, with ophthalmic surgical experience
• Ability to interact externally and internally to support global business strategy
• General knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developing and implementing clinical trials
• Must possess excellent oral and written English communication skills
• Ability to make clinical decisions on patient safety
• Be known as a person who has high integrity, sound character and a tremendous work ethic
• Ability to travel 50% of the time.
Compensation & Location:
In return for your training and expertise, this opportunity is offering a lucrative compensation package with a base salary, bonus eligibility and full benefits. The hiring organization wishes to discuss the details of the package on an individual basis with physicians as so much will hinge on your background as well as your personal needs. You’ll also benefit from living, working and, especially, playing in fabulous Los Angeles California! [Register to View] Need we say more?!
Contact:
Please contact Talent Medical Staffing for further details and to submit your CV. Sending your CV is the quickest way to connect with us (kept confidential). Contact us directly at [Register to View] or [Register to View] . Feel free to speak with any of our agents or leave a message on the mainline and we’ll return your call ASAP. You can also check out some of our other jobs online at [Register to View] We look forward to working with you!