591 Icon Plc jobs in India
Senior Clinical Research Associate - Drug Development
Posted 19 days ago
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Job Description
Responsibilities:
- Plan and execute clinical trial monitoring activities.
- Conduct site initiation, routine monitoring, and close-out visits.
- Ensure compliance with study protocols, SOPs, and regulatory guidelines (GCP, ICH).
- Verify data accuracy and integrity through source document review.
- Manage relationships with investigators, study coordinators, and site staff.
- Identify, document, and resolve site-level issues and deviations.
- Train and mentor site personnel and junior CRAs.
- Prepare monitoring reports and track action items.
- Ensure timely submission of regulatory documents.
- Contribute to the development of study-related documents (e.g., protocols, ICFs).
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum 5-7 years of experience as a Clinical Research Associate.
- Extensive knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience in site management, monitoring, and auditing.
- Strong understanding of clinical trial processes from start to finish.
- Excellent written and verbal communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to study sites as required.
- Detail-oriented with strong organizational and time management skills.
Senior Clinical Research Scientist - Remote Drug Development
Posted 22 days ago
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Job Description
The ideal candidate will possess a strong scientific background, with a proven track record in pharmaceutical research and development. You will be adept at translating scientific findings into actionable clinical research plans and communicating complex scientific information effectively to diverse audiences, including regulatory agencies, investigators, and internal stakeholders. This role demands excellent analytical, problem-solving, and critical thinking skills.
Key responsibilities include providing scientific leadership for clinical development programs, authoring study protocols and clinical study reports, and interpreting clinical data to assess drug efficacy and safety. You will collaborate closely with cross-functional teams, including biostatistics, data management, regulatory affairs, and medical affairs, to ensure successful trial execution. Staying abreast of the latest scientific advancements and regulatory changes in the pharmaceutical industry is essential.
We are looking for a self-motivated and results-oriented individual who can work independently and manage multiple projects concurrently in a remote setting. Excellent written and verbal communication skills are paramount. This is an exceptional opportunity to contribute to the development of life-saving medicines and advance your career in pharmaceutical research from anywhere.
**Responsibilities:***
- Design and develop clinical trial protocols for new drug candidates.
- Oversee the conduct of clinical trials, ensuring adherence to protocols and regulations.
- Analyze and interpret clinical trial data to assess safety and efficacy.
- Author study reports, manuscripts, and regulatory submission documents.
- Collaborate with internal and external stakeholders on clinical development strategies.
- Provide scientific expertise and guidance to project teams.
- Stay current with scientific literature and regulatory guidelines.
- Ph.D. or M.D. in a relevant life science discipline.
- Minimum 8 years of experience in clinical research within the pharmaceutical industry.
- Demonstrated experience in designing and managing Phase I-IV clinical trials.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Strong analytical and statistical interpretation skills.
- Excellent written and verbal communication abilities.
- Proven ability to work effectively in a remote, collaborative environment.
Clinical Pharmacologist - Drug Development
Posted 19 days ago
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Job Description
Responsibilities:
- Design and develop clinical pharmacology study protocols, including Phase I-IV studies, to characterize the PK/PD profiles of novel drug candidates and marketed products.
- Oversee the execution of clinical pharmacology studies, ensuring adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and scientific rigor.
- Analyze and interpret complex clinical pharmacology data, including PK, PD, and population PK/PD modeling.
- Prepare high-quality clinical pharmacology reports, summaries, and sections for Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other regulatory submissions.
- Provide expert scientific and strategic input on drug development programs, influencing dose selection, dosing regimens, and clinical trial designs.
- Collaborate effectively with internal teams (e.g., clinical operations, biostatistics, regulatory affairs, project management) and external partners (e.g., clinical research organizations (CROs), investigators).
- Stay current with scientific literature, regulatory guidelines, and industry best practices in clinical pharmacology.
- Contribute to the development of scientific publications and presentations.
- Evaluate and integrate data from various sources (e.g., preclinical, clinical, real-world evidence) to inform drug development decisions.
- Mentor junior pharmacologists and contribute to the scientific growth of the team.
- Ph.D. in Pharmacology, Pharmaceutical Sciences, Pharmaceutics, or a related discipline; MD with relevant experience will also be considered.
- Minimum of 5-7 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry.
- Proven expertise in designing, conducting, and analyzing clinical pharmacology studies (PK/PD, TGI, BA/BE).
- Strong understanding of regulatory requirements (FDA, EMA) related to clinical pharmacology.
- Experience with population PK/PD modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin) is highly desirable.
- Excellent scientific writing and oral communication skills.
- Demonstrated ability to work independently and collaboratively in a remote environment.
- Strong analytical and problem-solving abilities.
- Experience with therapeutic areas relevant to the company's pipeline is a plus.
Senior Formulation Scientist, Drug Development
Posted 6 days ago
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Job Description
Responsibilities:
- Lead the formulation development of new chemical entities (NCEs) and existing drugs into various dosage forms (e.g., oral solids, liquids, injectables).
- Design and conduct pre-formulation studies to understand the physicochemical properties of drug substances.
- Develop robust, scalable, and manufacturable formulations that meet product specifications and regulatory requirements.
- Characterize drug products using a variety of analytical techniques (e.g., HPLC, dissolution testing, DSC, XRD).
- Troubleshoot formulation and process-related issues encountered during development.
- Prepare development reports, protocols, and regulatory submission documents (e.g., IND, NDA).
- Collaborate with analytical development, process development, and manufacturing teams to ensure seamless technology transfer.
- Stay abreast of emerging trends, technologies, and regulatory guidelines in pharmaceutical formulation.
- Supervise and mentor junior scientists and technicians in the formulation laboratory.
- Contribute to the strategic planning of the formulation development pipeline.
- Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related discipline.
- Minimum of 6-9 years of hands-on experience in pharmaceutical formulation development within the industry.
- Proven track record of successfully developing and progressing formulations through the drug development pipeline.
- In-depth knowledge of various dosage forms, excipients, and drug delivery systems.
- Proficiency in analytical techniques used for drug product characterization.
- Strong understanding of regulatory requirements (e.g., FDA, EMA) for drug product development and submission.
- Excellent problem-solving, critical thinking, and experimental design skills.
- Strong written and verbal communication skills, with the ability to present scientific data effectively.
- Experience in managing projects and leading small teams is highly desirable.
This position is based in our state-of-the-art facility in Noida, Uttar Pradesh, IN . This role requires on-site presence and is not eligible for remote work.
Senior Formulation Scientist, Drug Development
Posted 10 days ago
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Job Description
Responsibilities:
- Design, develop, and optimize pharmaceutical formulations for various dosage forms (e.g., oral solids, injectables, topical).
- Conduct pre-formulation studies, including solubility, stability, and compatibility assessments of active pharmaceutical ingredients (APIs).
- Select appropriate excipients and formulation strategies to achieve desired drug delivery profiles and product performance.
- Develop and validate analytical methods for characterization of formulations.
- Scale-up formulation processes from laboratory to pilot and commercial manufacturing scales.
- Troubleshoot formulation and manufacturing-related issues.
- Conduct stability studies according to ICH guidelines and interpret results.
- Prepare comprehensive formulation development reports and contribute to regulatory submissions (e.g., IND, NDA).
- Collaborate with analytical development, process development, and manufacturing teams.
- Stay abreast of the latest advancements in pharmaceutical formulation science and drug delivery technologies.
- Mentor junior scientists and provide technical guidance.
- Ensure all activities are conducted in compliance with cGMP and other relevant regulatory standards.
- Evaluate new technologies and equipment for formulation development.
- Contribute to the intellectual property strategy of the company.
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
- Minimum of 8 years of hands-on experience in pharmaceutical formulation development.
- Extensive knowledge of various dosage forms, drug delivery systems, and excipients.
- Experience with pre-formulation studies, analytical method development, and stability testing.
- Proven ability to scale-up formulation processes.
- Strong understanding of cGMP principles and regulatory requirements (e.g., FDA, EMA).
- Excellent scientific reasoning, problem-solving, and data interpretation skills.
- Strong written and oral communication skills, with experience authoring technical reports and regulatory documents.
- Ability to work independently and effectively manage projects in a remote environment.
- Familiarity with common laboratory equipment and software used in formulation development.
- This role supports our operations in **Visakhapatnam, Andhra Pradesh, IN**, but is entirely remote.
Senior Formulation Scientist - Drug Development
Posted 11 days ago
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Job Description
Principal Scientist - Oncology Drug Development
Posted 13 days ago
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Job Description
Key Responsibilities:
- Lead the strategic direction and execution of preclinical and early-phase oncology drug development projects.
- Design and manage in vivo and in vitro studies to evaluate the efficacy, safety, and pharmacokinetics of novel oncology therapeutics.
- Collaborate closely with medicinal chemists, translational scientists, and clinical development teams to advance drug candidates.
- Interpret complex experimental data and translate findings into actionable development plans.
- Develop and implement biomarker strategies to support patient selection and therapeutic response monitoring.
- Stay at the forefront of oncology research, identifying emerging trends, technologies, and therapeutic opportunities.
- Prepare comprehensive regulatory submission documents (e.g., IND applications).
- Mentor and guide junior scientists and research staff, fostering scientific growth and excellence.
- Manage relationships with external collaborators, including academic partners and contract research organizations (CROs).
- Effectively communicate research progress, strategic decisions, and project outcomes to senior leadership and stakeholders.
- Ph.D. in Oncology, Molecular Biology, Immunology, Pharmacology, or a related field.
- Minimum of 10 years of progressive experience in oncology drug discovery and development within the pharmaceutical or biotechnology industry.
- Proven track record of successfully advancing oncology drug candidates from preclinical to clinical stages.
- Deep understanding of cancer biology, tumor microenvironment, and various therapeutic modalities (e.g., small molecules, antibodies, cell therapies).
- Extensive experience with preclinical pharmacology models and translational research strategies.
- Excellent leadership, project management, and team collaboration skills.
- Strong analytical and problem-solving abilities, with a data-driven approach to decision-making.
- Exceptional written and verbal communication skills, including experience with regulatory document preparation.
- Ability to thrive and lead effectively in a fully remote work environment.
- Demonstrated ability to publish in high-impact journals and present at international conferences.
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Senior Formulation Scientist - Drug Development
Posted 16 days ago
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Job Description
Key Responsibilities:
- Designing and executing pre-formulation studies to characterize drug substances and identify appropriate excipients.
- Developing and optimizing various dosage forms, including oral solids, liquids, semi-solids, and potentially sterile injectables, for small molecules and biologics.
- Performing stability studies according to ICH guidelines and analyzing results to determine shelf-life and storage conditions.
- Investigating and troubleshooting formulation-related issues encountered during development and manufacturing.
- Collaborating with analytical development teams to establish appropriate analytical methods for formulation characterization and quality control.
- Leading the scale-up of promising formulations from laboratory bench to pilot plant and manufacturing scale.
- Preparing comprehensive formulation development reports, CMC documentation, and regulatory submission support.
- Staying abreast of the latest advancements in formulation technologies, drug delivery systems, and regulatory requirements.
- Mentoring junior scientists and contributing to a collaborative team environment.
- Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards.
Senior Formulation Scientist, Drug Development
Posted 20 days ago
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Job Description
Key Responsibilities:
- Design, develop, and optimize pharmaceutical formulations for various dosage forms.
- Conduct pre-formulation studies, including solubility, stability, and compatibility assessments.
- Select appropriate excipients and carriers to achieve desired drug delivery profiles.
- Perform dissolution testing, drug release studies, and pharmacokinetic assessments.
- Develop and validate analytical methods for formulation characterization.
- Support formulation scale-up and technology transfer to manufacturing.
- Troubleshoot formulation challenges and identify root causes of issues.
- Collaborate with analytical development, process development, and regulatory teams.
- Prepare detailed reports, protocols, and submission documents.
- Stay abreast of industry trends, new technologies, and regulatory guidelines in formulation development.
- Contribute to intellectual property generation through patent applications.
- Master's degree or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 7 years of relevant experience in pharmaceutical formulation development.
- Proven expertise in developing various dosage forms (e.g., tablets, capsules, injectables, topical formulations).
- Strong understanding of physical chemistry, materials science, and drug delivery principles.
- Hands-on experience with laboratory equipment for formulation development and characterization.
- Knowledge of GMP requirements and regulatory guidelines for drug product development.
- Excellent analytical, problem-solving, and experimental design skills.
- Proficient in data analysis and scientific report writing.
- Strong collaboration and communication skills.
- Experience with controlled-release formulations or specialized delivery systems is a plus.
- Familiarity with CMC (Chemistry, Manufacturing, and Controls) documentation.
Senior Research Scientist, Oncology Drug Development
Posted 11 days ago
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Job Description
Responsibilities:
- Design, plan, and execute complex in vitro and in vivo experiments to evaluate the efficacy and safety of novel oncology drug candidates.
- Develop and validate assays for target engagement, pharmacodynamics, and biomarker analysis.
- Interpret experimental results, troubleshoot technical challenges, and propose innovative solutions.
- Analyze and present data clearly and concisely to internal teams and external collaborators.
- Contribute to the preparation of research reports, publications, and regulatory filings.
- Stay abreast of the latest scientific literature and technological advancements in oncology and drug discovery.
- Mentor and guide junior research associates, fostering a collaborative and high-performing team environment.
- Collaborate effectively with medicinal chemistry, pharmacology, toxicology, and clinical development teams.
- Ensure all research activities are conducted in compliance with company policies and regulatory guidelines.
- Ph.D. in Molecular Biology, Cancer Biology, Pharmacology, or a related field with a strong emphasis on oncology.
- Minimum of 5 years of postdoctoral or industry experience in drug discovery and development, with a proven track record in oncology.
- Extensive hands-on experience with various cancer models (cell lines, patient-derived xenografts) and relevant biological assays.
- Proficiency in data analysis software and statistical methods.
- Excellent written and verbal communication skills, with the ability to present complex scientific information effectively.
- Demonstrated ability to work independently and as part of a remote team.
- Strong problem-solving skills and a creative approach to scientific challenges.
- Experience with regulatory submission processes is a plus.