Clinical Research Organizations (cros)
My firm is doing a diligence project to determine the current growth trends of the market for clinical research organizations (cros). We would also like to understand the effect of the underlying market for r&d drug development and funding for biopharmaceutical companies.
We are hoping to speak to clinical research coordinator, project manager, study coordinators, etc., at pharma and biopharma companies who either focus on innovator or generic drug development. Former or current consultants in this role would be helpful.
Responsibilities of respondent:
familiarity with and understanding of how biopharma and pharmaceutical companies decide which cros to use for early stage clinical research. Will be able to speak to growth trends related to spending on r&d in industry and spending on cro services. To the extent possible, will be able to speak to how this may differ for innovator versus generic drugs. Will be able to speak to the reputations of different cro service providers.
The questions we would like to answer:
1) how has your spending on cro early stage services trended in the past few years? What is your outlook for demand for cro services? Why? To the extent you can speak to this, how has this differed for generic vs. Innovator drugs?
2) what is the decision process for determining which cro to use?
3) what factors are considered when determining which cro to use?
4) what are the cros that come to mind? Which cros have you considered? How do cro reputations differ across the different stages of clinical research (early vs. Late)? For different clinical services?
5) what are the trends for cro services moving overseas?
Please send a line if you are qualified to answer these questions. Thank you.+12 Other Responses
Bioanalytical Sciences, Drug Metabolism,
We are looking for experts (one in human drug metabolism and one in animal and human toxicology) to provide summary reviews of the extant literature on two active ingredients, which will be disclosed after a cda is signed. These are oral active agents, with one in rx use for decades and another for food use for a number of years. There is considerable published literature on each active. The review would inform the project team about possible pharm/tox and metabolic studies needed in support of a 505(b)(2) application, as well as the summary write-up for the ind application. Respondents to this search should have hands-on experience in rx drug development and an understanding of fda requirements for drug approval.+14 Other Responses
Chief Medical Officer
We're looking for a chief medical officer:
this position serves as a clinical and medical leader of the company and is responsible for developing and implementing the overall medical and clinical strategy that advocates for our patients overall health and well-being while delivering innovative products and technologies. the desired candidate will be skilled in clinical program design and execution in the context of a development organization. Experience and knowledge in interactions with clinical investigators, collaboration with regulatory affairs, and fda interactions is required.
Essential duties and responsibilities include the following. Other duties may be
accountable for the entire clinical development process
conceive and execute clinical strategy for all technology platforms
build, develop, and lead a motivated and engaged matrix team who are responsible for the day-to-day design and execution of clinical programs
lead preparation of clinical sections of all relevant regulatory filings (ide, pma, ind, clinical study reports, nda/bla, etc)
design and oversee protocols for all phases of a clinical program
advise on first in human decision point and endorse first dosing in humans
serve as an expert on clinical and medical issues
review study data, including safety monitoring, sae reporting, and analysis/tracking of emerging efficacy profile
write final study reports and prepare of documents for regulatory submission
interact with the broader invivo organization to share expertise
interact with key opinion leaders to ensure implementation of latest clinical thinking and guidelines into clinical development plans, as well as consideration of novel clinical methods
serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
manage strategic relationships with key partners
assist in the development of publications, abstracts, and presentations
represent the company at scientific meetings and presentations, interact with foundations, as well as other public relations opportunities
support business development activities as needed, including due diligence human resources:job descriptions:chief medical officer job description.Docx 7/16/2015
serve on leadership team of and provide clinical development insight to investment decisions
md or equivalent medical qualification
deep understanding of the biotechnology environment and the drug/device development process
demonstrated knowledge of designing, executing and delivering clinical programs to produce both timely and good quality data including knowledge of innovative clinical trial principles and methodologies
strong focus on finding innovative ways to leverage external expertise and funding, taking risk, focusing on new methods, exploring adjacent scientific
strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization, including senior management.+11 Other Responses