Clinical Trial is the department with many subspecialities. There are those who work directly on clinical studies and those who provide support functions. Some people make a distinction between the term “clinical development” and “clinical operations”. Clinical development to some sound like scientific and medical side of development, whereas operations reflect the more tactical aspect of running trials.
Clinical studies is categorized into following phases:
- Phase I studies: Tests drug safety, pharmacokinetics, and clinical pharmacology. The studies are usually conducted on a small group of healthy volunteers. Dose response curve are constructed and side effects are monitored to determine the optimum dose. The studies can test for a variety of qualities such as food drug or drug-drug interactions, pharmacokinetics, and pharmacodynamics. The generic drug industry conducts Phase I bioequivalence studies for products that are already in the market.
- Phase II Studies: The studies are conducted on larger groups of subject with the targeted condition or disease to test for proof of efficacy and to look for potential short term side effects or risks associated with drug.
- Phase III Studies: are large clinical trials that are generally include hundred and thousands of subjects. Studies are either controlled or uncontrolled, and are intended to gather additional information about effectiveness and safety of drug and to evaluate the overall benefit risk relationship.
- Phase IIIb/IV Studies: are extension of Phase III trials designed to study the drug in other disease states or in post approval commitment trials requested by the FDA for additional surveillance. The company continues to learn more about the product, identify possible drug-drug interaction and more.
Clinical Development and Operations
The titles and roles are described below::
- Chief Medical Officers: The chief medical officers is in charge of the company’s development programs. He or She will bring scientific expertise to the oversight of development plans,strategy,budget,drug safety,and other high level aspects of development.
- Clinical Team Leaders or Clinical Programs Directors: Usually MDs, or Phds, they are often responsible for writing and designing protocols and for leading the operation team who execute the study.
- Medical Monitor: Usually M.D., medical monitor offer drug and patient safety oversight during trials and provide the medical supervision to ensure that the study is conducted accurately.
- Associate Directors, Directors, and VPs, of Clinical Operations: Directors have more scientific and strategic responsibilities and tend to lead program in specific therapeutic areas.
- Program Managers, Trial Managers: Program managers supervise the operational side of the clinical development and have project management type responsibilities. The oversee the execution of national or international trials, determine programs budget and timelines, manage contracts research organization and help write regulatory submissions and safety documents.
- Principal Clinical Research Scientists: People in these positions might lead the protocol review and study design , oversee scientific aspects of the study and make sure the trials adhere to the regulatory requirements.
- Clinical research associates, Clinical Monitors, and Clinical Trial Coordinators: Clinical research associate operates at the heart of the clinical trial. They verify the accuracy of the data and ensure that the study is being conducted according to the FDA guidelines.
- Clinical Project Assistant and Contract Administrators: A clinical project assistant is a person in training who is involved and assisting CRAs, and program managers. Contract Administrator deal with the contracts and budgets.
We are very much familiar with the variety offered in the ClinicaL Research and Development Field. This field consists of large assortment of vocational courses. There is countless rooms for career enforcement. From becoming a Director to VP of a clinical research development, head of R&D, and finally into Chief Medical Officer, Chief operating officer, or CEO.Expertising in this field allows easy transition into other department such as marketing, regulatory affairs, and medical affairs. One can also try hand in FDA, drug safety or academia. It is not uncommon for a senior clinical executive to become consultant, venture capitalist or advisers to venture investment firms.
Job Security and Future Trends
There has always been a bulk demand for professionals in clinical development, most of the time the demand in clinical development exceeds the supply. Job security depends on the financial condition of the company and its pipeline of product. Though the projects in the clinical field could be stopped at any point due to efficacy or safety issues with the compound, lack of funding, and a multitude of external factors. If a product is doomed in clinical studies, either it is acquired or or may not survive or downsized. Small companies with one product in clinical studies generally offers less job security than larger companies. People who are very prone to risk should look for bid biotechnology or pharmaceutical companies with multiple drug development program.However be alert as the big companies can also be bought up, merged, or reorganised. Regardless if your company suffers one of these unfortunate fates, you can rest assured that you will be able to find another clinical position relatively easily.
In the upcoming years it is biens said that the demand for clinical professionals would be required in the Biotechnology field. This is due to the fact that the compounds need to be taken into development before being partnered. Compounds reaching Phase 2 of clinical trial brings in higher price tag for the company and also pose less development risk for the partners. With our large aging population , in combination with sequencing of the human genome, will likely drive explosive growth in drug delivery and development. The affinity for far less expensive processes may drive significant parts of clinical development programs outside the United States. CRAs, medical monitors, and data management positions might be at risk of being outsourced. Data management is already frequently outsourced to vendors in United States, and there is a trend to outsource those functions overseas. Clinical trial management, operations, and project management roles will likely not suffer the same fate, because those positions need to remain within company to ensure direct and timely communication with senior management.
Landing a Job in Clinical development
Experience and Educational Eligibility
This is a field with multiple jobs and functions, and as consequence, large variety of backgrounds are inappropriate. A medical degree is required for the position such as chief medical officer and medical monitor, but most other positions do not require one. Those already in the medical field tend to be the usual hires, but there are also many scientists with Phds,M.S.,and B.S.,degree in the field. Computer database managers,lawyers,and epidemiologists can be found well. Those with higher degrees such as M.D., and Phd., can often more easily move up to operational ranks. It is notable that need to have a medical background in order to flourish in this career. Physicians know how actually the medical system works and can speak with credentialed authority to the FDA about their clinical program. Most of the big Pharmaceutical companies prefer that their head of the department have specialization in medical field, but those with Phds, are frequently hired. M.Ds., would be given more clinical or safety responsibilities and will focus their efforts more on clinical development and protocol writing as opposed to operations.
Most physicians join companies at associate director level. They actually come from academic research centres, where they were industry sponsored researchers or investigators. A well celebrated researchers however can easily step in as VP. Foreigners with medical degrees usually join medical clinical department so they can apply their medical knowledge without having to become certified to practise medicine in the U.S.A. A common path for doctors is to become medical science liaisons first and then to transfer clinical development.
Those with advanced science degree(Phd and Master’s) have acquired a vast body of information which may not be directly applicable to clinical development. As a general rule, biological scientists tend to migrate into clinical pharmacology, translational, medicine and other phase1 type or work, or project management and clinical scientists position. Nurses are ideally suited for CRA and clinical monitor roles, as their knowledge of medical charts, terminology, and abbreviations used in clinical practise are useful for development.
Routes to Clinical Development
Even though there is huge demand of candidate in the clinical trials but still the path to the clinical development without prior experience is a tough task.
- Consider entry level positions such as CRAs, clinical study coordinators, or clinical trial specialists. These positions require little or no initial experience and serve excellent for beginning.
- The most convenient way to enter into this field is the CRO. CROs are excellent places to learn basics and gain exposure to multiple therapeutic areas and different type of drugs. They are well versed in clinical execution, regulation and guidelines and the large ones have outstanding educational and training programs.
- If you want to avoid the CRO route trahn consider a position as a project manager, study coordinator, or internal clinical research scientist. Your project management skills will later serve you well in clinical development. As a study coordinator you will be coordinating with internal and external groups to advance programs. You may also gain experience negotiating with the CROs,scheduling meetings and compiling informations.
- Consider taking a certificate or taking an additional course in the clinical trial management.There are literally dozens of different types of programs, course in auditing, clinical trial and project management, and medical writing in addition to training in clinical trials managements.
- If you are interested in taking a career in clinical pharmacology , consider taking pharmacokinetics, formulations, and preclinical and clinical pharmacology.
- For those who are working in hospitals, obtain experience conducting clinical trials. Try to become a study coordinator.
- Apply to companies that are focussed on the field of your specialty. People are often hired for their specific knowledge in the therapeutics area even if they lack substantial clinical experience.
- Pharmacists and those with medical degrees from foreign countries might initially consider obtaining a position as a medical science liaison or work in drug safety before transferring into clinical development.
- Consider joining FDA(CBER,CDER, and CDHR division). Such experiences will be invaluable for your career will make you more marketable and will provide a deeper understanding of FDA’s perspective on clinical studies.
- If you are currently working in academia try to obtain clinical experience. Take on clinical projects or consider postdoctoral fellowship in clinical research.
Other Departments in Clinical Development
- Translational Medicine, Translational Research, or Translational Development: Translational medicine is a vague term with several definitions, the broadest of which is taking research from idea to bedside. One aspect of translational medicine involves developing laboratory measurement of biological markers, i.e., protein,and RNA level, psychometric tests. Biomarkers can be used to select patients for clinical trial who would be more likely to respond to therapy.
- Clinical Pharmacology and Pharmacokinetics: Clinical pharmacology translates preclinical data into first in man Phase 1 studies. This includes testing dose-response and selecting dose for clinical trial.Clinical pharmacology studies evaluate pharmacokinetics, bioavailability. And deposition studies, safety, tolerability,and,if possible pharmacodynamics effect of each compound.
- Clinical Project Managers: Project management is an operation function in which the multidisciplinary aspect of the program are coordinated. Project managers generally do not work at trial levels. They oversee budget and timelines, manage relationship with contract research organisation and other vendor.
Salary and Compensation
Clinical development is a very bright career that tends to pay considerably better than those in most other areas of biopharma. The M.Ds., in this field can expect to earn higher salaries. Compensation for these jobs is comparable to that in regulatory affairs, business development, and marketing, and is better than discovery or preclinical research, manufacturing and quality.Doctors, nurses, and pharmacists may be compensated on par with hospital work depending on the position and therapeutic area. CRPs tend to play less than biopharma companies, but they provide more training for entry level hires and are more likely to provide more training for entry level hires, and are more likely to provide broad exposure to the entire drug development.
Positive Aspects of the Career
- It is immediately rewarding to know that you are contributing to the society.Bringing safe and useful new drugs to market has a great positive impact on the world.
- Original and applied clinical research is is exciting. Outcomes are unknown until the trials are completed, and each trial is close to market.
- Careers in Clinical Development currently offers exceptionally good job security. In addition because so many function exists in clinical development. This experience provides an easy transition into other areas, such as regulatory and medical affairs.
- Clinical studies play a visible, pivotal role in companies.
- There is tremendous amount of learning involved, especially when studying disease in rapidly developing fields it is exciting to be at cutting edge of scientific development
- This career provides in-depth understanding of drug development and its various discipline from regulatory affairs to marketing.
- Clinical development careers presents opportunities to meet many interesting and influential people. You may be interacting with clinical investigators and renowned experts, and internally, the clinical department tends to be composed of bright, hardworking individual from all over the world.
Roles and Responsibilities
- Development strategy:Development strategy consists of all research and development. Functional heads work in team from marketing, preclinical research, and other areas to assess products and their stages of development. Development strategy also involves making sure that the many moving parts in clinical development are properly functioning together as a unit.
- Designing Studies and Writing Clinical Protocols:The people in Clinical operations qualify, arrange contract with, and manage CROs. They oversee field monitors and work with biostatistician and medical writers and drug safety groups. Clinical Research associates visit clinical sites to verify that the study is conducted per protocol and that the data and samples are being collected and processed accurately.
- Medical Monitoring and Drug Safety Assessment: They review the clinical labs and patient inclusion and exclusion criteria and make that appropriate patients are enrolled.
- Data Managements: The information gathered from the clinical trials is entered into database. Data from case report forms and collections of tissue samples, pharmacokinetics results and more are stored in the database for final analysis.
- Clinical Trial Analysis and Biostatistics: After Clinical trials are completed and last of the data is entered, the database is “locked”, that is the information is altered. Thereafter the lead clinician and statistician then work together to analyse the result and draw conclusion.
- Interaction with key opinion Leaders: Clinical development professionals spend time becoming acquainted with and interacting with renowned experts, known in industry as “key opinion leader”. These important individual serve on FDA advisory board that discuss the merits of particular drug in specialized therapeutic areas.