Pet/mri Cro Translational Research
I am looking for experts who have worked in companies providing translational research services using pet/mri or a cro that provides pet/mri based services to drug development companies. I would like to know regulatory issues and solutions surrounding the business particularly in the uk and life of pet/mri instruments.
+7 Other ResponsesHistopathology
Hello,
histopathology services (animal and human analysis)
we are looking for expertise in the market segments of histopathology services (animal and human analysis) specifically
• sample preparation (e.G. Embedding/trimming/sectioning, staining and other technologies)
• image analysis
• pathology (including digital pathology)
regards,
harsh
+14 Other ResponsesTranslational Cardiac Repair Biology
We are a small biotech company developing drugs to help the heart regenerate cardiac tissue after a heart attack.
We are currently applying for various funding mechanisms (including grants) and looking for a consultant with translational experience in the biology of cardiac repair, e.G. Pre-clinical experimental studies in rats and pig models, evaluating both functional endpoings via echo's, mris or histopathological endpoints, to round out our team for current and future development projects.
+18 Other ResponsesDirector Of Clinical Operations
Director of clinical operations: (full-time, onsite position)
as a key member of the management team, the director of clinical operations will oversee studies on
our novel bioelectronic medicine platform, providing comprehensive clinical evidence to support marketing application
submissions. Reporting to the chief medical officer, the individual will be expected to:
work closely with the medical, regulatory, quality, and r&d teams on the design of our clinical development
program, and the plan for program execution
develop and manage operational plans for individual studies within the clinical development plan
author documents including clinical study protocols, investigator’s brochures and clinical study reports, and
collaborate in the preparation of manuscripts and external presentations
manage clinical trials service providers and suppliers and interact closely with investigative sites,
develop sops and guidelines, and ensure compliance with regulatory agency requirements
recruit, hire, and manage additional clinical team members
lead, collaborate with, and mentor employees in other functional areas
qualifications:
the ideal director of clinical operations candidate will have:
10 years of experience in a fast-paced, demanding
technical organization.
experience in clinical development of a class iii medical device is strongly preferred.
Experience in the inflammation therapeutic area or closely related areas is a plus.
experience working with fda and
other global regulatory agencies is preferred.
a bs or equivalent degree is required and a masters or doctoral level
degree is preferred.
Please attach your cv here to apply.
+13 Other ResponsesTranslational Research Head
The optimal candidate would be a phd or md/phd with 10+ year experience and a demonstrated track record of successful scientific oversight of late discovery through early development activities, including delineation of moa of development compounds and identification of biomarkers of target engagement and pharmacodynamic activity.
This person would work closely with scientists, preclinical safety, regulatory, and clinical groups to effectively develop integrated strategic objectives and research plans for early stage candidates. This would encompass programs from target identification through clinical proof of concept.
The current therapeutic focus is cardiometabolic, but liver disease and other therapeutic areas would be considered.
This person would need to:
exhibit an exceptional degree of scientific ingenuity, creativity and resourcefulness.
Make major contributions to the scientific direction of the company including evaluation of ongoing research and development and initiation of research that may lead to major new directions of identified programs.
Develop strategies to ensure effective achievement of scientific/business objectives.
Initiate, direct and execute scientific research and early development activities.
Developing an operating plan for early development and strategic objectives that support the company's research and development strategies.
May conduct and collaborate with others on basic research relevant to long-term objectives and concerns.
Define overall organizational structure and allocation of resources within early development.
Applies and/or develops highly advanced technologies, scientific principles, theories and concepts.
Recognized as a scientific leader within the company.
Provide leadership to direct others in solving complex problems.
Has demonstrated management and strategic planning skills.
Contribute to the scientific and career growth of employees.
Monitors project and program costs.
Collaborates on patent applications and manuscripts for publication.
Develops budgets for capital expenditures, personnel and contracts.
Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.
Education & experience:
-md or phd, md/phd
-minimum five years biotechnology/pharma industry experience required.
+26 Other ResponsesDiabetes Research
Need someone to summarize the expected developments in diabetes in the next five years. Expected deliverable no more than a page or two. Most importantly on clinics, and clinic operators.
+33 Other ResponsesSenior Director Clinical Development
-the optimal candidate to lead clinical development would be an md or md/phd with at least 10 years of experience in clinical development and a demonstrated track record of successful development activities, including first in human studies through later stage development, as well as building and managing a development group.
-this person would work closely with scientists, preclinical safety, regulatory, and clinical operations groups as well as executive leadership of the company to effectively develop integrated strategic objectives and development plans for early and late stage candidates.
-this person would also oversee and or coordinate development activities as clinical lead on development teams.
-this would encompass programs from lead candidate designation through clinical proof of concept and later stage development.
-the current therapeutic focus is cardiometabolic, but liver disease and other therapeutic areas would be considered.
This person would be expected to:
-lead the clinical development activities of multiple novel compounds across multiple therapeutic areas (cardiometabolic, liver, and oncology)
-develop and manage timelines and budgets for the programs including personnel, consultants and advisory boards
-work with translational scientist to help identify potential applications/indications for novel pathways/molecules of identified programs
-exhibit an exceptional degree of scientific ingenuity, creativity and resourcefulness
-initiate, direct and execute early development activities in conjunction with cros
-create operating plans for development and strategic objectives that support the company's research and development strategies.
-collaborate with others on developing a basic research plan for relevant to long-term programmatic objectives
-be recognized as a leader within the company
-provide leadership and direct others in solving complex problems surrounding the development of lead compounds
-has demonstrated management and strategic planning skills
-contribute to the career growth of employees
-effectively communicates complex issues to executive management
-collaborates on patent applications and manuscripts for publication.
-represents the company in regulatory interactions and scientific meetings
+10 Other ResponsesClinical Research
Looking for subject matter experts / consultants in clinical research, clinical trial, risk management, audit and inspection, gcp, clinical outsourcing, trial design and management,ethics fraud and misconduct, patient recruitment , documentation and management, clinical laboratories, facility/hospital , hospital clinical compliance, billing and coding for clinical services , patient/third-party coding and billing, sponsors, cros, clinical quality control/cqc for speaking engagements with over 25+ years of experience. Feel free to reach out to me.
+20 Other ResponsesClinical Pharmaceutical Distribution And Logistics
We are looking for experts with strong understanding in clinical pharmaceutical distribution and logistics network. We want to understand competitive landscape (key service providers), cost drivers, pricing and sourcing models for clinical trials logistics with a focus on european region.
+3 Other ResponsesPre-clinical Cro Market – Comparative Medicine
We are a global market research firm and are seeking experts who can assist us in understanding the ‘global pre-clinical cro market – comparative medicine’
key questions:
1. Kindly brief us on the key market trends related to comparative medicine (xenograft studies, lab animals and animal feed etc.) and toxicology studies
2. Which are the key innovations/advanced technologies offered by different vendors in the space of pre-clinical studies?
A. What is the impact of digitization on the management of animal breeds?
B. How the market is expected to evolve through 2025?
3. Which are the best practices adopted by leading pharmaceutical companies to build a category strategy in the space of comparative medicine and toxicology studies?
4. Kindly provide information around the current market scenario of pre-clinical studies including animal testing, in-vivo testing, pharmacokinetics and toxicology etc.
5. Which are the leading vendors in the global pre-clinical services market?
A. Which is the preferred vendor segment for ease of animal sourcing?
B. Kindly name top 10 vendors. What % market share do they occupy from the global pre-clinical services market? Which are their key capabilities?
6. Which are the different types of pricing models in the industry?
A. Rate card vs module based pricing
b. Most adopted pricing model currently
7. Information around animal supply chain (key focus on monkey supply) for pre-clinical studies.
A. Are there any chances of animal supply shortage in the future?
B. Which are the most preferred regions for animal sourcing and why?
I. Is asia getting more preferred for animal (monkey) supply?
C. Information on the animal supply market dynamics and how the global market place is evolving through 2025?
8. Case studies explaining best practices adopted by leading pharmaceutical companies to build a category strategy-
a. How leading pharma companies are managing the category - comparative medicine and toxicology studies (in terms of supplier identification, and contracting)?
B. Most adopted engagement models
c. Most adopted pricing models
d. How do the pharma companies streamline the process of managing the category and stakeholders?
E. Cost reduction strategies
we are looking for a phone consult for a period of 1 hour to discuss all points mentioned above.
+24 Other ResponsesClinical Development
Our client has an immediate need to conduct phone consults with multiple experts knowledgeable about best and worst practices for all capabilities of clinical development organization within pharma companies. More specifically, our client would like to better understand best practices revolving around structural organization and roles in these settings, as well as mechanisms for project collaboration, processes for clinical trials, forecasting, capacity management, governance and common pain points. Please note, this ask is specific to experience in the united states. Ideal candidates should have a deep knowledge of this space, and recent former experience at a large pharmaceutical company. Preferred expert will have recent (within the last 2-4 years) experience in a clinical development role at a large pharma company, speficially pfizer or merck. (client cannot speak to anyone currently employed by a pharmaceutical company). This project has a budget.
+35 Other ResponsesClinical Laundry Service In Uk
I looking for information pertaining to clinical laundry service cost across uk specific to norfolk and norwich area.
+6 Other Responses