80 Clinical Development jobs in India
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 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.
Clinical Database Development Specialist - Remote
Posted 2 days ago
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Job Description
**A Day in the Life**
**Responsibilities may include the following and other duties may be assigned.**
**Candidate should have minimum 4 years of experience.**
**Design, develop, document, test and/ or support clinical study databases and configuration of cross-system interfaces per business process.**
**- May support the design, development, testing, and/or maintenance of Clinical Reports, Clinical Data Transfers or other components related to clinical studies.**
**- Understand industry standards and apply them.**
**- Partner as clinical technical specialists in the planning, designing, and implementing of clinical applications**
**- Provide technical consultation on and task direction for vendors**
**- Mentor more junior team members**
**- Project Management tasks, such as time management, manage budget, manage milestones, communicate progress, resolve issues**
**- Stay current on technologies, methods, standards, and best practices as well as trends and direction of the clinical data management industry**
**- Review and acknowledge all Standard Operating Procedures and other quality requirements assigned to the job role.**
**SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.**
**Specialized Knowledge Required:**
**Clinical database systems knowledge: advanced level of proficiency with clinical electronic data capture (EDC) systems, such as Medidata Rave, and clinical trial management systems. Big-picture and detail-oriented view of development processes, tools and procedures. Familiarity with SQL and advanced query development**
**DIFFERENTIATING FACTORS**
**Autonomy:** **Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.**
**Organizational Impact:** **Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.**
**Innovation and Complexity:** **Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.**
**Communication and Influence:** **Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.**
**Leadership and Talent Management:** **May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.**
**Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.**
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
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Senior Clinical Research Scientist - Remote Drug Development
Posted 23 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.
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 12 days ago
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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.
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 21 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.