Clinical Development

Clinical Development

Clinical development defines the entire process of bringing a new drug or medical device to market. From drug discovery and product development, to preclinical research and clinical trials, the development process is a long and difficult process. Yet for the determined, each failure helps advance scientific knowledge, propels the life sciences field forward,
and, once in a while, the ultimate reward of delivering a successful and safe product to market that transforms millions of lives.

Only one or two compounds in 10,000 tested actually make it through to being licensed treatments. A potential new medicine may be rejected at any point in the development process on safety, effectiveness or quality grounds. Overall, it
may take 10-15 years for a new compound to get from the test tube to the medicine cabinet, and90% of medicines that are testedin people donโ€™t reach the market because they are unsafe or ineffective.

The use of technology in the clinical development process has been on the rise in recent years as its ability to speed up the process is being recognised. Weโ€™re likely to see an increasing push toward the acceptance of wearables for use in clinical trials. Although itโ€™s in the embryonic phase, the impact of wearables could be huge.According to Astra Zenecaโ€™s Matthew Bonam, by 2020, โ€œ70-80% of the data being collected will be by the patient in their own home, rather than centres. This should also lead to massive savings in cost.

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Benefits of working with us

Experience

We have over a decadeโ€™s worth of experience as a leading talent partner in Life Sciences & Pharma.

Network

A vast, global network of the best, in-demand professionals, working with the worldโ€™s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

Knowledge

Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

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Clinical Development Jobs

Associate Director, Clinical Science

We are seeking a highly skilled individual to join our client's team in Osaka, Japan. As the Associate Director of Clinical Science for Gastroentology (GI) and Inflammation, you will play an integral role in developing innovative pharmaceutical products that help improve patient lives. Key Responsibilities: Lead clinical development programs related to inflammation Develop study designs aligned with regulatory requirements Analyze data from preclinical studies Manage cross-functional teams Qualifications: Bachelor's Degree in science department, PhD or MD preferred. At least 5 years' experience working on clinical trials within gastrointestinal diseases or inflammation. Strong understanding of inflammatory bowel disease / gastroenterology therapeutic area, including familiarity with relevant literature; Knowledgeable about regulations governing drug development activities; Billingual Apply today by submitting your CV today.

Negotiable
Osaka
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Head of Biometrics

Company: Innovative Biotechnology Company Job Title: Head of Biometrics Location: California, USA Salary: $220,000 - $330,00 plus an attractive bonus and benefits structure Company Summary: Our client is an innovative Biotechnology company dedicated to the development of antibodies in advance cancers. With funding from multiple investors, for their extensive pipeline, the company offer a stable career and development plan. As the first hire for their Biometrics team, you will be responsible for the growth of the team, including, Statisticians, Programmers and Clinical Data Management. Reporting directly to the CMO, you will be part of the board of directors, discussing and making strategic decisions for the company. Responsibilities: Lead the Biometrics function for the company, including, recruiting, developing the team of biostatistics, data management and statistical programming Providing strategic statistical input related to program and portfolio decisions Pivotal role in driving statistical strategy of clinical development providing statistical input to drug development planning Responsible for establishing FIH trial designs, and ensuring appropriate statistical parameters are in place Provides strategic statistical and regulatory guidance to anticipate challenges, risk and ensure project success Train new biostatisticians and programmers as necessary Draft, review and provide guidance for statistical sections of protocols, statistical analysis plans and for soundness of trial design Lead, Support and Oversee execution of Clinical Development Activities Qualifications PhD in Statistics, Biostatistics or related field of study Minimum of 15+ years; of experience in the Pharmaceutical or Biotechnology industry Proven track record of growing teams in a small company environment 7 years' minimum experience of management experience leading Biostatistics and programming supporting clinical trials Extensive knowledge of Oncology across Phase I - IV studies Strong understanding of regulatory requirements and experience with regulatory interactions

US$220000 - US$330000 per year
San Diego
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Senior Manager, Clinical Data Management

Company: Innovative Biotechnology Company Job Title: Senior Manager, Clinical Data Management Location: San Diego, California Salary: $126,000 - 164,000 + bonus + RSU Company Summary: Our client is an innovative Biotech company who produces allogenic cell therapies for patients with autoimmune diseases and oncology. With an exciting pipeline and a few commercialized products, they have an exceptional level of funding having generated 270million in their series B runway. They have a fantastic team culture, focusing on the science and improving the lives of cancer patients nationwide. Due to the success of two compounds, there is now an urgent need to hire and grow out the team. This will be the second hire within the Clinical Data Management sub team. They are seeking an experienced Senior Manager, Clinical Data Management, who will report directly to the Director of CDM. This role will be responsible for Data Management from study start-up to close-out. Duties/Responsibilities: Review and approve all data management documents, including, case report forms, data management plan, build and validation specifications Lead UAT activities Ensure the development of project level timelines Review and provide feedback to the wider clinical teams on statistical analysis and monitoring plans Participate in regular study and project team meetings Provide oversight of Data Management and liase with CROs EDC System modifications Serious Adverse Event (SAE) and third-party data reconciliations Requirements: Minimum 5-8 years of pharmaceutical, biotech or pharmaceutical experience Bachelor's degree in science, computer science, or related field preferred Successfully managing and overseeing Data Management activities directly or through CRO and providers Data Management document knowledge e.g. CRFs, DMP Understanding of regulatory guidelines and industry standards e.g. ICH GCP and FDA guidelines, 21 CFR 11 Extensive knowledge of EDC systems e.g. Medrio Knowledge in Oncology or Autoimmune Therapeutic areas are preferred In addition to a great culture, they offer: Highly competitive base salary, plus bonus and RSU, making it one of the best packages on the market 401(k) Retirement Plan Attractive PTO, including company paid holidays

Negotiable
San Diego
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Medical Lead

About the Job: Lead and drive clinical development strategy for key programs. Act as the medical lead and sponsor's safety physician, collaborating closely with Clinical Operations, Trial Manager, and CRO for effective study delivery. Join a dynamic and growing organisation, contributing to impactful development programs and growing with the company's expanding clinical development enterprise. Exciting opportunity to make a significant impact from the start. Responsibilities: * Contribute to building and managing the clinical strategy for clinical programs and studies. * Perform medical monitoring for clinical studies, with a focus on patient safety and trial conduct. * Interpret overall data and oversee safety surveillance in assigned trials. * Establish and approve scientific methods for designing clinical protocols, data collection systems, and final reports. * Lead or assist in designing clinical development plans and strategies for compounds or therapeutic classes. * Draft clinical trial protocols and efficiently finalise clinical documents through cross-functional collaboration. * Collaborate with pre-clinical, translational sciences, and senior management in assessing product requirements. * Provide leadership on cross-functional product development teams. * Identify, select, and negotiate with clinical research sites and investigators. * Participate in selection and management activities of Contract Research Organisations (CROs). * Supervise project team members in planning, conducting, and evaluating clinical trials. * Drive fiscal responsibility with operational budget management and cost-saving initiatives. * Ensure compliance with Standard Operating Procedures (SOPs) and policies, adhering to Good Clinical Practices (GCP). Requirements: * Medical Doctor (MD) required, Neurology or Psychiatry experience preferred (Board Eligible/Board Certified Neurologist a plus). * 3-5+ years of experience in CRO/pharma/biotech organizations, GCP expertise; pharmaceutical experience highly desired. * 3+ years of Central Nervous System (CNS) clinical research experience, capable of drafting clinical development plans and protocols. * Proficient in medical monitoring/safety physician role, with expertise in reviewing safety cases and drafting clinical narratives. * Strong verbal and written communication skills for diverse audiences, including colleagues, stakeholders, and upper management. * High ethical and quality standards demonstrated through actions and communication. * Ability to work independently and seek guidance when needed. * Proven critical and creative thinking skills. * Experience in identifying opportunities for continual improvement. * Demonstrated ability to thrive in a fast-paced, matrix environment. Work Environment: Based in Paris Languages: French English

ยฃ150000 - ยฃ150001 per annum
Paris
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Head of Clinical Development

Head of Clinical development Our client is a leading biotech company seeking an experienced and dynamic individual to fill the role of Head of Clinical Development. Based in beautiful Marseille, you will be responsible for overseeing all clinical development programs from Phase I through regulatory approval. Qualifications: - Advanced degree (MD or PhD) with a minimum 10 years' experience in oncology drug development - Strong leadership skills with previous management experience at VP level or above - Proven track record managing complex global studies within timelines and budget constraints Responsibilities: As the successful candidate for this position, your responsibilities will include but are not limited to: * Be responsible for the design and execution of the clinical strategy of early assets based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity * Lead the Global Clinical Development Team, a cross functional multinational team of internal experts, from candidate selection to the design and execution of the required exploratory clinical studies and advancement to registration studies * Create and translate Target Product Profile into clinical strategy * Oversee protocol development * Enable decision-making by interpreting safety and efficacy data taking into account relevant PK/PD data working together with a cross-functional team * Serve as the primary clinical contact for study medical and patient safety aspects supported by Pharmacovigilance and Clinical Trial Scientist * Supervise employees, both directly and indirectly * Develop high impact relationships with internal partners across research, translational science, and clinical development functions as well as establish, lead, and manage relationships with key external stakeholders (e.g. investigators, Key Opinion Leaders, health authorities) Skills Required: In order succeed on our team you should possess these attributes : * Excellent communication skills both verbal/written/english & french language proficiency preferred . * Ability manage competing priorities effectively while maintaining attention detail without sacrificing quality results being produced. * Demonstrate sound judgement when making difficult decisions under pressure If you believe that this job matches your skillset then we invite you apply today !

Negotiable
France
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Associate Director, Clinical Science

We are seeking a highly skilled individual to join our client's team in Osaka, Japan. As the Associate Director of Clinical Science for Gastroentology (GI) and Inflammation, you will play an integral role in developing innovative pharmaceutical products that help improve patient lives. Key Responsibilities: Lead clinical development programs related to inflammation Develop study designs aligned with regulatory requirements Analyze data from preclinical studies Manage cross-functional teams Qualifications: Bachelor's Degree in science department, PhD or MD preferred. At least 5 years' experience working on clinical trials within gastrointestinal diseases or inflammation. Strong understanding of inflammatory bowel disease / gastroenterology therapeutic area, including familiarity with relevant literature; Knowledgeable about regulations governing drug development activities; Billingual Apply today by submitting your CV today.

Negotiable
Osaka
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Medical Director, Oncology

We are currently seeking a Medical Director in Oncology to join a reputable pharmaceutical company based in Osaka, Japan. This is a full-time permanent position and an excellent opportunity for someone who is passionate about Oncology and seeks to make a difference in the field. Responsibilities: Provide medical leadership and expertise in Oncology Develop and implement medical strategies and plans Act as the primary medical point of contact for internal and external stakeholders Ensure compliance with regulatory requirements Provide medical input into clinical development plans, including clinical study protocols, clinical study reports, and regulatory submissions Provide medical input into the development of promotional materials and marketing programs Build strong relationships with key opinion leaders and medical experts in Oncology Participate in internal and external medical education and training activities Provide medical input into the development of publications and presentations Skills: Medical Doctor Oncology experience Clinical Development experience Experience in pharmaceuticals Strong leadership skills Excellent communication and interpersonal skills Strategic thinking and planning skills Ability to work independently and as part of a team Ability to manage multiple projects simultaneously If you are interested, please apply with your CV attached.

Negotiable
Osaka
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Clinical Trial Manager

An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in Singapore This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.

Negotiable
Singapore
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Clinical Trial Manager

An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in Singapore This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.

Negotiable
Singapore
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Medical Director, Oncology

We are currently seeking a Medical Director in Oncology to join a reputable pharmaceutical company based in Osaka, Japan. This is a full-time permanent position and an excellent opportunity for someone who is passionate about Oncology and seeks to make a difference in the field. Responsibilities: Provide medical leadership and expertise in Oncology Develop and implement medical strategies and plans Act as the primary medical point of contact for internal and external stakeholders Ensure compliance with regulatory requirements Provide medical input into clinical development plans, including clinical study protocols, clinical study reports, and regulatory submissions Provide medical input into the development of promotional materials and marketing programs Build strong relationships with key opinion leaders and medical experts in Oncology Participate in internal and external medical education and training activities Provide medical input into the development of publications and presentations Skills: Medical Doctor Oncology experience Clinical Development experience Experience in pharmaceuticals Strong leadership skills Excellent communication and interpersonal skills Strategic thinking and planning skills Ability to work independently and as part of a team Ability to manage multiple projects simultaneously If you are interested, please apply with your CV attached.

Negotiable
Osaka
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Clinical Trial Manager

An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in Singapore This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.

Negotiable
Singapore
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Scientific Director Advisor Consultant

My client is a globally recognized biotechnology company at the forefront of pioneering research. My client is seeking seeking an individual with a healthy blend of scientific expertise, clinical development experience, and a comprehensive understanding of regulatory requirements, with experience in Genetic Obesity research. Role Overview: As a Genetic Obesity SME, this consultant will play a crucial role in conducting a deep dive into the scientific landscape of genetic obesity. These insights will drive research and clinical development strategies in this innovative field. Key Responsibilities: Perform a detailed review of existing scientific literature and ongoing research in genetic obesity. Provide expert insights to guide research and clinical development strategies. Collaborate with internal teams, including R&D, clinical operations, and regulatory affairs, ensuring alignment of scientific understanding and strategy. Stay updated on emerging trends, technologies, and developments in genetic obesity research. Prepare and deliver detailed reports and presentations to convey findings and recommendations to diverse stakeholders. Qualifications: Advanced degree (PhD preferred) in Genetics, Molecular Biology, or a similar field. Minimum 5 years of experience in pharmaceutical sponsor research, with some experience in obesity and related genetic disorders. Demonstrated experience in genetic obesity research, with record of publications. Experience in clinical development, including the design and implementation of clinical trials. Understanding and familarity with the regulatory environment and requirements in the pharmaceutical industry. Exceptional communication and presentation skills, capable to convey complex scientific concepts effectively. Strong analytical and problem-solving skills, paired with a commitment to scientific rigor and detail. Ability to work independently and collaboratively within a team.

US$80 - US$110 per hour
Boston
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