80 Clinical Development jobs in India

Clinical Pharmacologist - Drug Development

700091 Kolkata, West Bengal ₹1800000 Annually WhatJobs

Posted 19 days ago

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full-time
Our client is a pioneering pharmaceutical company committed to advancing global health through groundbreaking research and development. We are seeking a highly motivated and accomplished Clinical Pharmacologist to play a crucial role in the drug development lifecycle. This is a remote-first position, allowing you to contribute from anywhere while collaborating with a world-class team of scientists and clinicians. You will be instrumental in designing, executing, and interpreting clinical pharmacology studies, contributing vital data to support regulatory submissions and optimize therapeutic strategies. The ideal candidate will possess a deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), drug metabolism, and drug interactions, coupled with extensive experience in clinical trial design and data analysis.

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.
Qualifications:
  • 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.
This is a fully remote position, offering a unique opportunity to shape the future of medicine from the comfort of your home office. Join our innovative team and contribute to bringing life-changing therapies to patients worldwide.
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Senior Clinical Research Associate - Drug Development

110001 Delhi, Delhi ₹60000 Annually WhatJobs

Posted 19 days ago

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full-time
Our client, a leading pharmaceutical organization, is seeking a highly experienced Senior Clinical Research Associate (CRA) to support groundbreaking drug development efforts in Delhi, Delhi, IN . This pivotal role involves overseeing and managing clinical trials to ensure adherence to protocols, regulatory requirements, and ethical standards. As a Senior CRA, you will be responsible for site selection, initiation, monitoring, and close-out activities for clinical trial sites. This includes conducting on-site and remote monitoring visits to verify data accuracy, patient safety, and regulatory compliance. You will serve as the primary point of contact between the study sites, the sponsor, and the investigational team, ensuring clear and consistent communication. Developing and maintaining strong relationships with investigators and study coordinators is crucial for the successful execution of trials. The Senior CRA will review and reconcile source documents, case report forms (CRFs), and other trial-related documentation. You will also be instrumental in identifying and resolving site-level issues, escalating critical problems as needed, and ensuring timely resolution. Training and mentoring junior CRAs and site staff on protocol requirements and good clinical practice (GCP) is an integral part of this position. A thorough understanding of FDA, ICH-GCP, and other relevant regulatory guidelines is mandatory. The ability to manage multiple complex trials simultaneously and maintain meticulous records is essential. This role offers a challenging yet rewarding opportunity to contribute significantly to bringing life-saving therapies to patients.

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).
Qualifications:
  • 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.
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Clinical Database Development Specialist - Remote

Mumbai, Maharashtra Medtronic

Posted 2 days ago

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Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**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 ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
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Senior Clinical Research Scientist - Remote Drug Development

390007 Vadodara, Gujarat ₹120000 Annually WhatJobs

Posted 23 days ago

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full-time
Our client is seeking a highly experienced Senior Clinical Research Scientist to join their fully remote drug development team. This is a critical role focused on designing, implementing, and monitoring clinical trials for novel pharmaceutical compounds. You will be responsible for developing clinical protocols, analyzing trial data, and ensuring compliance with regulatory guidelines and ethical standards. This position requires a deep understanding of clinical trial methodologies, pharmacology, and disease pathophysiology.

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.
**Qualifications:***
  • 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.
Contribute to groundbreaking pharmaceutical research from your home base, impacting global health outcomes.
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Senior Formulation Scientist, Drug Development

201301 Noida, Uttar Pradesh ₹1600000 Annually WhatJobs

Posted 6 days ago

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full-time
Our client, a rapidly growing pharmaceutical company, is seeking a highly skilled and innovative Senior Formulation Scientist to join their Product Development team. This critical role will focus on the research, development, and optimization of novel drug formulations for various therapeutic areas. You will be responsible for designing and executing formulation studies, characterizing drug products, and ensuring robust and scalable manufacturing processes. The ideal candidate will possess a strong scientific background in pharmaceutical sciences, extensive experience in formulation development, and a deep understanding of regulatory requirements.

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.
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Senior Formulation Scientist, Drug Development

530001 Visakhapatnam, Andhra Pradesh ₹2000000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a renowned pharmaceutical company, is seeking a highly accomplished Senior Formulation Scientist to lead innovative drug development projects. This is a fully remote position, allowing you to contribute your expertise from anywhere in India. You will be at the forefront of designing, developing, and optimizing pharmaceutical formulations for novel drug candidates. This role demands extensive knowledge of drug delivery systems, excipients, pre-formulation studies, and scale-up processes. You will collaborate with multidisciplinary teams, including medicinal chemists, analytical scientists, and regulatory affairs specialists, to bring new therapies from concept to clinical trials.

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.
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Senior Formulation Scientist - Drug Development

600001 Chennai, Tamil Nadu ₹1800000 Annually WhatJobs

Posted 12 days ago

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full-time
Our client, a prominent pharmaceutical company, is actively seeking a highly skilled Senior Formulation Scientist to drive innovative drug development initiatives in their state-of-the-art research facility located in Chennai, Tamil Nadu, IN . This role is instrumental in the design, development, and optimization of novel drug formulations across various therapeutic areas. The ideal candidate will possess a deep understanding of pharmaceutical sciences, formulation development principles, and drug delivery systems. Responsibilities include leading pre-formulation studies, designing and executing experiments to develop stable, effective, and bioavailable dosage forms (e.g., oral solids, injectables, topical). You will be responsible for characterizing drug substances and excipients, conducting compatibility studies, and optimizing formulation parameters using advanced analytical techniques. The Senior Formulation Scientist will also perform scale-up studies, support technology transfer to manufacturing, and contribute to regulatory documentation, including CMC sections of IND and NDA filings. Collaboration with analytical development, process development, and regulatory affairs teams is essential. Experience with various dosage forms and drug delivery technologies is highly desirable. The ideal candidate will possess excellent problem-solving abilities, strong analytical skills, and a meticulous approach to experimental design and data interpretation. A PhD or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field is required. A minimum of 5-7 years of relevant experience in pharmaceutical formulation development within the industry is mandatory. Proficiency in relevant laboratory techniques and instrumentation is expected. This is a critical role that requires innovation, scientific rigor, and a commitment to bringing life-changing medicines to patients. You will be part of a dedicated team contributing to the advancement of pharmaceutical research and development.
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Principal Scientist - Oncology Drug Development

500081 Hyderabad, Andhra Pradesh ₹160000 Annually WhatJobs

Posted 13 days ago

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full-time
Our client is seeking a highly accomplished and visionary Principal Scientist to lead cutting-edge oncology drug development programs. This is a fully remote position, offering a unique opportunity to contribute to life-saving cancer therapies from your home office. The ideal candidate will hold a Ph.D. in a relevant life science discipline, with extensive experience in preclinical and early-stage clinical development of oncology drugs. You will be instrumental in designing and executing innovative research strategies, managing complex projects, and guiding cross-functional teams towards successful drug candidate selection and advancement. This role demands exceptional scientific leadership, a profound understanding of cancer biology and therapeutic modalities, and the ability to drive research forward in a collaborative, remote setting. Your expertise will play a vital role in accelerating the development of novel treatments for cancer patients globally. We are dedicated to fostering an environment of innovation and high performance for our remote workforce.

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.
Qualifications:
  • 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.
This role is fully remote, allowing flexibility in your work location across India. While the company has a significant presence in Hyderabad, Telangana, IN , this position is remote-first.
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Senior Formulation Scientist - Drug Development

682024 Kochi, Kerala ₹1150000 Annually WhatJobs

Posted 16 days ago

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full-time
Our client, a leading pharmaceutical innovator, is seeking a highly skilled Senior Formulation Scientist to join their drug development team in Kochi, Kerala, IN . This role is integral to the design, development, and optimization of novel drug delivery systems and pharmaceutical formulations. The ideal candidate will possess extensive expertise in pharmaceutical sciences, with a strong track record in pre-formulation studies, formulation development, and scale-up of various dosage forms. You will play a key role in advancing drug candidates from early-stage research through to clinical trial readiness, contributing significantly to the company's pipeline.

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.
A Master's or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field is required, along with a minimum of 7 years of hands-on experience in pharmaceutical formulation development. Proven experience with a variety of dosage forms and advanced drug delivery technologies is essential. Strong knowledge of excipient science, drug-excipient compatibility, and biopharmaceutical principles is mandatory. Experience with stability testing, analytical techniques (HPLC, dissolution, etc.), and regulatory affairs is highly desirable. Excellent problem-solving, communication, and interpersonal skills are critical for success in this role. This is an outstanding opportunity to contribute to the development of life-changing medicines.
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Senior Formulation Scientist, Drug Development

600001 Chennai, Tamil Nadu ₹2700000 Annually WhatJobs

Posted 21 days ago

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full-time
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Formulation Scientist to join their innovative Drug Development team in Chennai, Tamil Nadu, IN . This role is pivotal in the design, development, and optimization of pharmaceutical formulations for novel drug candidates. The Senior Formulation Scientist will be responsible for developing stable, effective, and manufacturable dosage forms across various routes of administration, including oral, parenteral, and topical. You will conduct pre-formulation studies, solubility enhancement, excipient compatibility testing, and dissolution studies. Key responsibilities include designing experimental protocols, executing laboratory work, analyzing data, and interpreting results to guide formulation strategies. The successful candidate will possess a deep understanding of pharmaceutical sciences, physical chemistry, and pharmaceutics, along with hands-on experience in formulation development, scale-up, and technology transfer. Experience with various dosage forms and manufacturing processes is essential. You will collaborate closely with analytical chemists, process engineers, and regulatory affairs specialists to advance drug candidates through the development pipeline. This position requires excellent problem-solving skills, strong scientific judgment, and the ability to manage multiple projects simultaneously. A commitment to quality, regulatory compliance (e.g., GMP), and driving successful product development is paramount.

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.
Qualifications:
  • 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.
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  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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