Clinical Trials Disclosure Mgr

Hyderabad, Andhra Pradesh Amgen

Posted 7 days ago

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**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
+ Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Support trend analysis and continuous improvement initiatives
+ Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
+ Working experience with disclosures on public registries e.g. ClinicalTrials.gov
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Good communication skills including excellent spoken and written English
+ Ability to follow controlled processes
+ Leadership skills, including ability to teach, negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
**Basic Qualifications:**
+ Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
OR
+ Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry
+ Minimum of 2 years experience in preparation of regulatory documents for public disclosure
+ Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Associate - PAI & Clinical Trials

Hyderabad, Andhra Pradesh Amgen

Posted 16 days ago

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**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will report to the Amgen India R&D Finance lead. The R&D Finance Associate will assist in planning, quarter close and consolidation activities. The candidate is also expected to expand the centralization, automation and standardization practices established in R&D Finance team.
+ FP&A professional skilled in comprehensive financial data management, financial analysis and forecasting, ad hoc project financial support, and process optimization.
+ Support functional and consolidation teams in R&D finance
+ Master Data Maintenance including but not limited to managing and updating financial master data across all systems to ensure accuracy and integrity, cost center creation, modification, and deactivation, aligning them with the organizational structure, creation of Work Breakdown Structures (WBS) for precise project tracking and financial reporting.
+ Provide headcount and staffing support by maintaining relevant data and assisting in workforce planning. Support efficient data migration from the business planning tool to financial system
+ FE&O and Staff Support planning and Variance Analysis: Conduct variance analysis to identify trends and discrepancies between actuals and forecasts. Forecasting of certain trended/low risk planning accounts
+ Product Coding and Recovery Optimization: Support product coding processes and recovery methods to improve financial accuracy and efficiency.
+ Handle Ad hoc requests: Providing accurate and timely support to stakeholders.
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications:**
Master's degree and 0 to 2 years of accounting and/or finance (OR)
Bachelor's degree and 0 to 2 years accounting and/or finance (OR)
**Preferred Qualifications:**
Pharmaceutical / biotechnology industry experience
Knowledge and understanding of financial planning processes, quarter close activities
Strong analytical skills and exceptional attention to detail
Excellent discernment (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas)
**Good To Have Skills**
Big 4 and Fortune 500 FP&A experience
Capable of building models and financial reports
Technical finance knowledge and skills (accounting, planning, modeling, etc.)
Overall knowledge of financial systems and tools (e.g., SAP, Hyperion, Anaplan, Excel)
Business partnering skills. Ability to work effectively in ambiguous situations and team environment
**Soft Skills:**
Effective analytical and communication skills (both verbal and written)
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Collaborative, with a focus on achieving team goals
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This advertiser has chosen not to accept applicants from your region.

Medical Writing / Research Analyst

Hyderabad, Andhra Pradesh DAVA Oncology

Posted 9 days ago

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Social Worker (Delhi Office – Healthcare Programs)
Location: New Delhi | Full-time | 50% Travel Required
About Jiv Daya Foundation
Jiv Daya Foundation (JDF) is a U.S.-based private foundation committed to improving the quality of life for underserved populations. In India, JDF supports several healthcare programs, including Tuberculosis, Rheumatology, Maternal and Neonatal Health, and Eye Care Initiatives. Our programs are implemented in collaboration with government hospitals, academic institutions, and local partners.
About the Role
We are looking for a passionate and organized Social Worker to join our Delhi-based office. This position will work across multiple healthcare initiatives—primarily Tuberculosis and Rheumatology initiative—to support patient engagement, access to care, and coordination with treatment centers. The role requires frequent field travel (~50%) to government hospitals and patient homes in and around Delhi.
Key Responsibilities
  • Support TB and Rheumatology patients with treatment adherence, follow-up, and emotional counseling.
  • Assist patients in applying for government and non-government aid programs at both state and central levels.
  • Help patients and caregivers with documentation, form submissions, and navigating official processes for availing treatment support.
  • Create and maintain a repository of state and national-level patient assistance schemes and health entitlements.
  • Track and follow up with patients regularly to ensure continuity of care and linkage to appropriate support programs.
  • Coordinate with hospital social work departments, government agencies, and NGOs to ensure patient needs are addressed.
  • Identify and build a local donor network, including individuals and community-based groups, willing to support patients financially or in-kind.
  • Maintain accurate patient records, gather field-level insights, and contribute to regular reporting and documentation.
  • Assist in field logistics, coordination with healthcare staff, and support day-to-day project operations.

Required Qualifications

  • Master’s degree in Social Work, Public Health, or a related field
  • .Graduates from institutions like TISS, PHFI, or similar are strongly encouraged to apply
  • .2–4 years of relevant experience in healthcare-related social work or public health programs
.
This advertiser has chosen not to accept applicants from your region.

Medical Writing / Research Analyst

Secunderabad, Andhra Pradesh DAVA Oncology

Posted 9 days ago

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Job Description

Social Worker (Delhi Office – Healthcare Programs)
Location: New Delhi | Full-time | 50% Travel Required
About Jiv Daya Foundation
Jiv Daya Foundation (JDF) is a U.S.-based private foundation committed to improving the quality of life for underserved populations. In India, JDF supports several healthcare programs, including Tuberculosis, Rheumatology, Maternal and Neonatal Health, and Eye Care Initiatives. Our programs are implemented in collaboration with government hospitals, academic institutions, and local partners.
About the Role
We are looking for a passionate and organized Social Worker to join our Delhi-based office. This position will work across multiple healthcare initiatives—primarily Tuberculosis and Rheumatology initiative—to support patient engagement, access to care, and coordination with treatment centers. The role requires frequent field travel (~50%) to government hospitals and patient homes in and around Delhi.
Key Responsibilities
  • Support TB and Rheumatology patients with treatment adherence, follow-up, and emotional counseling.
  • Assist patients in applying for government and non-government aid programs at both state and central levels.
  • Help patients and caregivers with documentation, form submissions, and navigating official processes for availing treatment support.
  • Create and maintain a repository of state and national-level patient assistance schemes and health entitlements.
  • Track and follow up with patients regularly to ensure continuity of care and linkage to appropriate support programs.
  • Coordinate with hospital social work departments, government agencies, and NGOs to ensure patient needs are addressed.
  • Identify and build a local donor network, including individuals and community-based groups, willing to support patients financially or in-kind.
  • Maintain accurate patient records, gather field-level insights, and contribute to regular reporting and documentation.
  • Assist in field logistics, coordination with healthcare staff, and support day-to-day project operations.

Required Qualifications

  • Master’s degree in Social Work, Public Health, or a related field
  • .Graduates from institutions like TISS, PHFI, or similar are strongly encouraged to apply
  • .2–4 years of relevant experience in healthcare-related social work or public health programs
.
This advertiser has chosen not to accept applicants from your region.

Pharmaceutical Research Scientist

500001 Shaikpet, Andhra Pradesh ₹70000 Annually WhatJobs

Posted 19 days ago

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full-time
Our client, a leading pharmaceutical company, is looking for a dedicated Pharmaceutical Research Scientist to join their state-of-the-art research and development facility in Hyderabad, Telangana, IN . This role is crucial for driving innovation in drug discovery and development. You will be involved in various stages of the research process, from hypothesis generation to experimental design, execution, data analysis, and reporting. The ideal candidate will have a strong scientific background, hands-on laboratory experience, and a passion for advancing healthcare.

Key Responsibilities:
  • Conduct in-vitro and in-vivo experiments to evaluate the efficacy and safety of drug candidates.
  • Design and optimize experimental protocols and methodologies.
  • Analyze experimental data using statistical software and interpret results accurately.
  • Maintain meticulous laboratory notebooks and prepare detailed scientific reports.
  • Contribute to the formulation of new research strategies and project proposals.
  • Stay abreast of the latest scientific literature and technological advancements in the pharmaceutical field.
  • Collaborate with cross-functional teams, including chemists, biologists, and clinicians.
  • Ensure compliance with all relevant safety regulations and laboratory best practices.
  • Present research findings at internal meetings and external scientific conferences.
  • Assist in the preparation of regulatory documents and patent applications.

Qualifications:
  • Master's or Ph.D. in Pharmacology, Biochemistry, Biotechnology, or a related life science discipline.
  • Minimum of 3 years of post-doctoral or industry research experience in drug discovery.
  • Proven expertise in relevant laboratory techniques and instrumentation.
  • Strong understanding of pharmacokinetic and pharmacodynamic principles.
  • Proficiency in data analysis software (e.g., GraphPad Prism, R) and Microsoft Office Suite.
  • Excellent written and verbal communication skills.
  • Ability to work independently and as part of a collaborative research team.
  • Meticulous attention to detail and strong organizational skills.
This position offers a competitive salary, comprehensive benefits, and the chance to make a significant impact on the development of life-saving medicines. Join a company committed to scientific excellence in Hyderabad, Telangana, IN .
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Principal Pharmaceutical Research Scientist

500001 Shaikpet, Andhra Pradesh ₹1200000 Annually WhatJobs

Posted today

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full-time
Our client, a leading pharmaceutical company at the forefront of drug discovery, is seeking a highly accomplished Principal Pharmaceutical Research Scientist to contribute to their innovative R&D efforts in Hyderabad, Telangana, IN . This senior-level position requires a deep scientific understanding, extensive research experience, and the ability to lead complex projects from conception to completion. You will be instrumental in developing novel therapeutic agents and advancing our client's pipeline.

Key Responsibilities:
  • Lead and conduct cutting-edge research projects focused on the discovery and development of new pharmaceutical compounds.
  • Design and execute complex experiments, analyze data, and interpret results to guide research strategies.
  • Develop and validate novel assays and experimental methodologies.
  • Oversee and mentor junior scientists and research associates, fostering a collaborative and innovative research environment.
  • Collaborate with internal teams (e.g., medicinal chemistry, pharmacology, toxicology) and external partners to advance drug candidates.
  • Prepare high-quality scientific reports, publications, and patent applications.
  • Present research findings at scientific conferences and internal review meetings.
  • Contribute to the strategic direction of the research department and identify new areas of scientific exploration.
  • Ensure compliance with all relevant safety regulations, ethical guidelines, and company policies.
  • Stay current with the latest scientific literature, technologies, and trends in pharmaceutical research.
  • Troubleshoot complex scientific challenges and propose innovative solutions.

Qualifications:
  • Ph.D. in Pharmacology, Molecular Biology, Biochemistry, or a closely related field.
  • Minimum of 8-10 years of post-doctoral or industry research experience in drug discovery.
  • Demonstrated expertise in a specific therapeutic area or drug discovery platform.
  • Proven track record of successful research project leadership and delivery.
  • Extensive experience with relevant experimental techniques, data analysis, and interpretation.
  • Strong publication record in peer-reviewed journals.
  • Excellent leadership, mentoring, and team-building skills.
  • Exceptional written and oral communication skills.
  • Ability to think critically and creatively to solve complex scientific problems.
  • Familiarity with regulatory requirements for drug development (e.g., FDA, EMA).
  • Experience working in a hybrid R&D environment.

This is a pivotal role for a seasoned scientist looking to make a significant impact on the development of life-saving medicines.
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Senior Pharmaceutical Research Scientist

500001 Shaikpet, Andhra Pradesh ₹95000 Annually WhatJobs

Posted today

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full-time
Our client is seeking an experienced and highly motivated Senior Pharmaceutical Research Scientist to join their dynamic R&D team in **Hyderabad, Telangana, IN**. This is an exciting opportunity for a seasoned professional to contribute to cutting-edge drug discovery and development projects. The ideal candidate will possess a strong background in medicinal chemistry, pharmacology, or a related life science discipline, coupled with a proven track record of successfully bringing drug candidates from early-stage research through preclinical development.

Responsibilities:
  • Design and synthesize novel small molecules with therapeutic potential.
  • Conduct in vitro and in vivo experiments to evaluate drug efficacy and safety.
  • Analyze and interpret complex biological and chemical data.
  • Collaborate with cross-functional teams, including biologists, toxicologists, and formulation scientists.
  • Prepare comprehensive research reports, scientific publications, and patent applications.
  • Stay abreast of the latest scientific advancements and emerging technologies in pharmaceutical research.
  • Mentor junior scientists and contribute to the overall scientific strategy of the department.
  • Ensure compliance with all relevant regulatory guidelines and company policies.
  • Manage external collaborations with academic institutions and contract research organizations.
  • Contribute to the identification and prioritization of new drug targets.
Qualifications:
  • Ph.D. in Medicinal Chemistry, Pharmacology, Biochemistry, or a closely related field.
  • Minimum of 5-7 years of post-doctoral or industry experience in pharmaceutical R&D.
  • Extensive knowledge of drug discovery processes and methodologies.
  • Proficiency in modern synthetic organic chemistry techniques and analytical methods (e.g., NMR, Mass Spectrometry, HPLC).
  • Demonstrated experience with in vitro assays and cell-based models.
  • Familiarity with preclinical animal models and pharmacokinetics/pharmacodynamics (PK/PD) studies is highly desirable.
  • Excellent problem-solving skills and the ability to think critically and creatively.
  • Strong written and verbal communication skills, with the ability to present complex scientific information clearly.
  • Proven ability to work effectively both independently and as part of a collaborative team.
  • Experience with project management and leading scientific initiatives is a plus.
This role offers a competitive salary, comprehensive benefits package, and opportunities for professional growth within a leading pharmaceutical organization. Join us in making a significant impact on patient lives through innovative medicine.
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Lead Pharmaceutical Research Scientist

500001 Shaikpet, Andhra Pradesh ₹2500000 Annually WhatJobs

Posted 1 day ago

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full-time
Our client is seeking a highly accomplished and innovative Lead Pharmaceutical Research Scientist to join their cutting-edge R&D department in Hyderabad, Telangana, IN . This pivotal role involves leading a team of scientists in the discovery and development of novel therapeutic agents. You will be responsible for designing and executing complex research projects, analyzing experimental data, and contributing to the intellectual property portfolio. The ideal candidate will possess a deep understanding of medicinal chemistry, pharmacology, and drug development processes, with a proven track record of scientific innovation and publication. You will guide research strategies, mentor junior scientists, and collaborate with cross-functional teams, including clinical development, regulatory affairs, and manufacturing. This position requires strong leadership, exceptional analytical and problem-solving skills, and the ability to thrive in a dynamic, research-intensive environment. A hybrid work model will allow for a balance of in-lab research and strategic planning. Responsibilities:
  • Lead and mentor a team of research scientists in the discovery and preclinical development of new drug candidates.
  • Design and implement innovative research programs focused on identifying and optimizing novel therapeutic targets.
  • Oversee the execution of in vitro and in vivo studies to evaluate drug efficacy, safety, and pharmacokinetic profiles.
  • Analyze and interpret complex experimental data, drawing meaningful conclusions and identifying key insights.
  • Contribute to the preparation of scientific publications, patents, and regulatory submissions.
  • Collaborate with internal and external stakeholders, including academic institutions and CROs.
  • Develop and manage research budgets, ensuring efficient resource allocation.
  • Stay abreast of the latest advancements in pharmaceutical research, therapeutic areas, and competitive intelligence.
  • Ensure compliance with all relevant laboratory safety protocols, ethical guidelines, and regulatory requirements.
  • Present research findings at scientific conferences and internal review meetings.
  • Contribute to the strategic direction of the drug discovery pipeline.
  • Identify and evaluate new technologies and methodologies to enhance research capabilities.
Qualifications:
  • Ph.D. in Pharmacology, Medicinal Chemistry, Biochemistry, or a closely related field.
  • Minimum of 7 years of post-doctoral research experience in the pharmaceutical industry.
  • Demonstrated experience in leading research projects and mentoring scientific staff.
  • Strong publication record in peer-reviewed journals and relevant patent filings.
  • Expertise in one or more therapeutic areas (e.g., oncology, infectious diseases, CNS disorders).
  • Proficiency in modern drug discovery techniques, assay development, and high-throughput screening.
  • Excellent analytical, critical thinking, and problem-solving skills.
  • Exceptional written and verbal communication skills, with the ability to present complex scientific data effectively.
  • Experience working in a hybrid research environment.
  • Proven ability to collaborate effectively in a multidisciplinary team setting.
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Principal Pharmaceutical Research Scientist

500001 Shaikpet, Andhra Pradesh ₹1800000 Annually WhatJobs

Posted 2 days ago

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full-time
Our client is looking for a visionary Principal Pharmaceutical Research Scientist to join their cutting-edge research team, operating entirely remotely. This role is integral to the discovery and development of novel therapeutic agents. You will spearhead innovative research projects, from initial concept to preclinical development, focusing on identifying and validating new drug targets and developing promising drug candidates. The ideal candidate will possess a deep understanding of drug discovery processes, molecular biology, pharmacology, and medicinal chemistry, with a proven ability to design and execute complex experiments independently. You will be expected to analyze research data, interpret results, and present findings to internal teams and external collaborators. This is a fully remote position, requiring excellent self-management, communication, and collaboration skills to thrive in a virtual environment. You will work closely with cross-functional teams, including bioinformatics, toxicology, and clinical development, to advance our pipeline.

Responsibilities:
  • Lead and conduct complex research projects in drug discovery and development.
  • Identify and validate novel drug targets for various diseases.
  • Design and synthesize potential drug candidates and evaluate their efficacy and safety in vitro and in vivo models.
  • Develop and optimize experimental protocols and assays.
  • Analyze and interpret large datasets, drawing meaningful conclusions.
  • Prepare detailed research reports, scientific publications, and patent applications.
  • Collaborate effectively with internal teams and external partners in a remote setting.
  • Mentor junior scientists and contribute to a culture of scientific excellence.
  • Stay abreast of the latest scientific advancements and technological innovations in the pharmaceutical industry.
  • Manage project timelines and resources efficiently.

Qualifications:
  • Ph.D. in Pharmacology, Biochemistry, Molecular Biology, Medicinal Chemistry, or a related field.
  • 10+ years of relevant research experience in the pharmaceutical industry or academia.
  • Demonstrated expertise in drug discovery, target validation, and lead optimization.
  • Proficiency in relevant experimental techniques and analytical methods.
  • Strong publication record in peer-reviewed journals.
  • Excellent communication, presentation, and interpersonal skills, crucial for remote collaboration.
  • Proven ability to work independently and as part of a distributed team.
  • Experience with bioinformatics tools and data analysis software is a plus.
This position offers a highly competitive salary, comprehensive benefits package, and the opportunity to contribute to groundbreaking pharmaceutical advancements from the comfort of your home office.
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Senior Pharmaceutical Research Scientist

500001 Shaikpet, Andhra Pradesh ₹1500000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client, a globally recognized pharmaceutical company at the forefront of medical innovation, is seeking a highly motivated and experienced Senior Pharmaceutical Research Scientist to join their R&D team. This hybrid role offers a blend of on-site collaboration and remote flexibility, allowing you to contribute to groundbreaking drug discovery and development projects. You will play a critical role in identifying, synthesizing, and characterizing novel therapeutic compounds, driving our client's pipeline forward.

Key responsibilities include:
  • Designing and executing complex experimental protocols for drug discovery and preclinical development.
  • Synthesizing and purifying small molecules with therapeutic potential.
  • Utilizing advanced analytical techniques (e.g., HPLC, LC-MS, NMR) to characterize compound properties and purity.
  • Conducting in vitro and in vivo studies to evaluate drug efficacy, safety, and pharmacokinetic profiles.
  • Analyzing experimental data, interpreting results, and preparing comprehensive reports and publications.
  • Collaborating with medicinal chemists, biologists, pharmacologists, and regulatory affairs specialists.
  • Mentoring junior scientists and contributing to the development of research strategies.
  • Maintaining detailed laboratory notebooks and adhering to Good Laboratory Practices (GLP).
  • Identifying and evaluating new technologies and methodologies to enhance research capabilities.
  • Contributing to the intellectual property portfolio through patent applications.

The ideal candidate will possess a Ph.D. in Medicinal Chemistry, Organic Chemistry, Pharmacology, or a closely related field, with a minimum of 5 years of post-doctoral or industry experience in pharmaceutical research. A strong track record in synthetic organic chemistry, assay development, and drug metabolism studies is essential. Experience with targeted drug delivery systems, computational chemistry, or specific therapeutic areas (e.g., oncology, immunology) is a plus. Excellent problem-solving skills, a proactive approach to research, and the ability to work effectively in both team-based and independent settings are required. This role requires approximately 2-3 days per week in our Hyderabad facility, with the remaining days available for remote work, offering a dynamic work-life balance.
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