697 Regulatory Affairs Departments jobs in India
Senior Formulation Scientist, Drug Development
440001 Nagpur, Maharashtra
₹100000 Annually
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Posted 2 days ago
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Job Description
Our client is actively seeking a highly skilled and experienced Senior Formulation Scientist to join their cutting-edge, fully remote research and development team. This critical role is at the forefront of pharmaceutical innovation, focusing on the design, development, and optimization of novel drug formulations. The ideal candidate will possess a Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, or a related discipline, coupled with a substantial track record in pre-formulation, formulation development, and scale-up activities for various dosage forms. You will be responsible for leading projects from concept to clinical trial readiness, employing advanced scientific principles and state-of-the-art technologies. Key responsibilities include developing robust formulations for small molecules and/or biologics, characterizing drug substances and excipients, and conducting stability studies. This position demands a deep understanding of regulatory requirements (e.g., FDA, EMA), a commitment to rigorous scientific inquiry, and the ability to translate complex scientific data into actionable development plans. The Senior Formulation Scientist will collaborate closely with analytical chemists, process engineers, and other R&D scientists, contributing to the overall drug development pipeline. This is a unique opportunity to work in a remote-first environment, contributing to life-saving medicines while maintaining a flexible work-life balance. Responsibilities:
- Design and develop stable, efficacious, and bioavailable drug formulations.
- Conduct pre-formulation studies to understand drug substance properties.
- Select and evaluate appropriate excipients for formulation development.
- Perform formulation optimization studies using DoE methodologies.
- Characterize formulated products using various analytical techniques.
- Develop and validate analytical methods for formulation assessment.
- Plan and execute stability studies according to ICH guidelines.
- Support process development and scale-up activities for manufacturing.
- Troubleshoot formulation and process-related issues.
- Stay abreast of the latest advancements in pharmaceutical formulation science and technology.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 7 years of relevant industry experience in pharmaceutical formulation development.
- Extensive knowledge of various dosage forms (e.g., oral solid, parenteral, topical).
- Proficiency in formulation development techniques and characterization methods.
- Strong understanding of GMP, ICH guidelines, and regulatory submission requirements.
- Experience with drug substance characterization and solid-state properties.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills.
- Ability to work independently and manage multiple projects effectively in a remote setting.
- Experience with biologics formulation is a plus.
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Senior Formulation Scientist - Drug Development
380001 Ahmedabad, Gujarat
₹1100000 Annually
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Posted 8 days ago
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We are seeking a highly skilled and experienced Senior Formulation Scientist to join our innovative pharmaceutical R&D team in Ahmedabad, Gujarat . The successful candidate will be responsible for the design, development, and optimization of novel drug formulations, focusing on oral dosage forms. This role requires a strong scientific background, hands-on laboratory experience, and a deep understanding of pharmaceutical sciences and regulatory requirements.
Responsibilities:
Responsibilities:
- Design and execute pre-formulation studies to characterize drug substances.
- Develop and optimize formulations for various dosage forms, with a primary focus on oral solids (tablets, capsules).
- Evaluate and select appropriate excipients to achieve desired drug product performance and stability.
- Perform laboratory experiments to investigate solubility enhancement, bioavailability improvement, and controlled/sustained release profiles.
- Utilize analytical techniques (e.g., HPLC, UV-Vis, dissolution testing) for characterization and quality control of formulations.
- Prepare comprehensive study protocols, reports, and technical documentation for regulatory submissions.
- Troubleshoot formulation-related challenges and implement effective solutions.
- Collaborate with analytical development, process development, and regulatory affairs teams.
- Stay abreast of the latest advancements in formulation technologies and industry best practices.
- Mentor junior scientists and contribute to the scientific growth of the R&D department.
- Ensure compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines.
- Participate in cross-functional project team meetings and contribute to strategic decision-making.
- Master's or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related discipline.
- Minimum of 5-7 years of hands-on experience in pharmaceutical formulation development, with a focus on oral dosage forms.
- Proven expertise in formulation design, excipient selection, and drug product characterization.
- Proficiency in analytical methods for drug substance and drug product characterization.
- Strong understanding of physicochemical properties, biopharmaceutics, and pharmacokinetics.
- Experience with various dosage form manufacturing processes and equipment.
- Knowledge of regulatory requirements for drug development (e.g., ICH guidelines).
- Excellent problem-solving, analytical, and critical-thinking skills.
- Strong written and verbal communication skills, with the ability to present scientific data effectively.
- Ability to work independently and collaboratively in a fast-paced R&D environment.
- Experience with pre-formulation studies and solid-state characterization techniques.
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1
Senior Formulation Scientist, Drug Development
226001 Lucknow, Uttar Pradesh
₹1100000 Annually
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Posted 13 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a talented and experienced Senior Formulation Scientist to drive innovation in drug product development. This hybrid role is crucial for designing, developing, and optimizing pharmaceutical formulations for new and existing drug candidates. You will work at the forefront of pharmaceutical science, translating complex molecular entities into safe, effective, and stable dosage forms. The ideal candidate will possess a deep understanding of pharmaceutical sciences, excipient functionality, and drug delivery systems.
Key Responsibilities:
Key Responsibilities:
- Design and develop robust formulations for various dosage forms (e.g., oral solids, injectables, topical).
- Conduct pre-formulation studies to characterize drug substances and excipients.
- Optimize formulations to achieve desired physicochemical properties, bioavailability, and stability.
- Plan and execute formulation development experiments, including scale-up and technology transfer.
- Develop and validate analytical methods for the characterization of drug products.
- Prepare detailed technical reports, formulation development protocols, and regulatory submission documents.
- Collaborate with cross-functional teams including R&D, analytical development, DMPK, and regulatory affairs.
- Troubleshoot formulation-related issues and provide solutions to manufacturing challenges.
- Stay abreast of scientific advancements, new technologies, and regulatory guidelines in pharmaceutical formulation.
- Manage project timelines and resources effectively.
- Mentor junior scientists and contribute to their professional development.
- Conduct literature searches and patent reviews related to formulation development.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 5-7 years of hands-on experience in pharmaceutical formulation development.
- Proven expertise in developing various dosage forms and understanding of drug delivery systems.
- In-depth knowledge of excipient functionality, compatibility, and selection.
- Experience with analytical techniques used for characterizing drug products (e.g., HPLC, DSC, XRPD).
- Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements (e.g., ICH guidelines).
- Excellent problem-solving, analytical, and critical-thinking skills.
- Strong written and verbal communication skills, with the ability to present complex data clearly.
- Proficiency in scientific literature databases and formulation software.
- Ability to work effectively in a collaborative, cross-functional team environment.
- Experience with stability studies and data interpretation.
- Demonstrated ability to manage projects and meet deadlines.
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2
Lead Formulation Scientist - Drug Development
570001 Mysore, Karnataka
₹140000 Annually
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Posted 14 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to advancing global health, is seeking an experienced Lead Formulation Scientist to join their innovative research and development department in Mysuru, Karnataka, IN . This senior role is pivotal in the development of novel drug delivery systems and the optimization of existing pharmaceutical formulations. The Lead Formulation Scientist will guide the entire formulation development process, from pre-formulation studies to pilot scale-up, ensuring the efficacy, stability, and safety of new drug products. You will collaborate with chemists, analytical scientists, and regulatory affairs specialists to bring life-saving medications to market. This is an exceptional opportunity for a highly skilled formulation expert to lead critical projects and influence the future of pharmaceutical innovation.
Key Responsibilities:
Key Responsibilities:
- Lead the design, development, and optimization of oral solid dosage forms (tablets, capsules) and potentially other dosage forms (e.g., injectables, topicals).
- Conduct pre-formulation studies to understand drug substance characteristics relevant to formulation development.
- Develop scientifically sound formulation strategies to improve drug solubility, bioavailability, and patient compliance.
- Perform experiments to evaluate excipient compatibility, drug-excipient interactions, and critical process parameters.
- Oversee the scale-up of laboratory-scale formulations to pilot and commercial manufacturing processes.
- Develop and validate analytical methods for characterizing formulated products.
- Ensure all formulation activities comply with Good Manufacturing Practices (GMP) and regulatory guidelines.
- Collaborate with analytical development teams to ensure product quality and stability.
- Provide technical guidance and mentorship to junior formulation scientists and technicians.
- Prepare comprehensive development reports, regulatory submission documents (e.g., IND, NDA sections), and scientific presentations.
- Stay current with advancements in formulation science, drug delivery technologies, and pharmaceutical manufacturing.
- Troubleshoot formulation and manufacturing issues, providing scientific expertise for resolution.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical formulation development.
- Proven expertise in oral solid dosage form development, including tablet and capsule manufacturing.
- Strong understanding of drug substance characterization, excipient functionality, and manufacturing processes.
- Experience with pre-formulation techniques, solubility enhancement, and controlled/sustained release technologies.
- Familiarity with analytical techniques used for drug product characterization (e.g., HPLC, dissolution testing, DSC).
- Knowledge of GMP regulations and experience preparing regulatory documentation.
- Excellent problem-solving, critical thinking, and experimental design skills.
- Strong leadership, project management, and communication abilities.
- Ability to work effectively in a cross-functional team environment.
- Experience with statistical analysis and design of experiments (DoE) is a plus.
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3
Senior Formulation Scientist - Drug Development
500001 Hyderabad, Andhra Pradesh
₹1000000 Annually
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Posted 16 days ago
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Our client, a leading pharmaceutical company, is seeking an experienced Senior Formulation Scientist to join their innovative Research and Development division. This role, based in **Hyderabad, Telangana, IN**, is integral to the development of novel drug delivery systems and optimizing the formulation of new chemical entities (NCEs) and generic drugs. You will be responsible for designing, executing, and documenting pre-formulation studies, formulation development, and process optimization for various dosage forms. Responsibilities include: Designing and conducting pre-formulation studies to characterize drug substances. Developing robust and scalable formulations for oral, parenteral, topical, and other dosage forms. Performing stability studies according to ICH guidelines. Optimizing formulation processes and excipient selection. Troubleshooting formulation challenges and scale-up issues. Collaborating with analytical development, DMPK, and regulatory affairs teams. Preparing technical reports, study protocols, and CMC documentation for regulatory submissions. Staying current with scientific literature, industry trends, and new technologies in pharmaceutical formulation. Mentoring junior scientists and contributing to a culture of scientific excellence. The ideal candidate holds a Master's or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field. A minimum of 5-7 years of hands-on experience in pharmaceutical formulation development is required. Strong knowledge of various dosage forms (e.g., tablets, capsules, injectables, topical preparations) and their manufacturing processes is essential. Experience with formulation development for NCEs and generics is highly desirable. Proficiency in relevant laboratory techniques and analytical instrumentation is required. Excellent problem-solving, critical thinking, and communication skills are necessary. This hybrid role offers the opportunity to work in a state-of-the-art facility and contribute to the advancement of life-saving medications.
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4
Senior Formulation Scientist - Drug Development
302001 Jaipur, Rajasthan
₹1300000 Annually
WhatJobs
Posted 16 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to advancing healthcare, is seeking a highly skilled Senior Formulation Scientist to join their Drug Development team. This role is central to the development of innovative drug formulations, ensuring the efficacy, safety, and stability of new therapeutic products. The ideal candidate will possess extensive experience in pharmaceutical formulation science, including solid dosage forms, sterile products, or parenteral formulations, along with a deep understanding of pre-formulation, formulation development, and scale-up processes. You will lead formulation projects, collaborate with cross-functional teams, and contribute to regulatory submissions. This position requires a strong scientific background, excellent problem-solving abilities, and a commitment to pharmaceutical quality standards.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Lead the design, development, and optimization of novel drug formulations for various dosage forms (e.g., tablets, capsules, injectables, topicals).
- Conduct pre-formulation studies to characterize drug substances and excipients.
- Develop and validate robust formulation and manufacturing processes.
- Perform stability studies and interpret data to assess product shelf-life.
- Troubleshoot formulation-related issues and propose effective solutions.
- Collaborate closely with analytical development, DMPK, and manufacturing teams.
- Prepare scientific reports, technical documentation, and contribute to regulatory submissions (e.g., IND, NDA).
- Stay abreast of the latest advancements in formulation science and pharmaceutical technology.
- Supervise and mentor junior scientists and research associates.
- Manage project timelines and deliverables effectively.
- Ensure adherence to cGMP guidelines and quality standards throughout the development process.
- Evaluate new excipients and drug delivery technologies.
Qualifications:
- Master's degree or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 5 years of experience in pharmaceutical formulation development.
- Hands-on experience with various dosage forms and formulation techniques.
- Proficiency in pre-formulation characterization and drug delivery systems.
- Strong understanding of physical chemistry, materials science, and analytical techniques.
- Experience with scale-up and technology transfer activities.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present scientific data.
- Knowledge of regulatory requirements (e.g., FDA, EMA) related to drug product development.
- Experience in a hybrid work environment is beneficial.
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5
Remote Clinical Research Scientist - Drug Development
110001 Delhi, Delhi
₹1600000 Annually
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Posted 10 days ago
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Job Description
Our client, a leading pharmaceutical innovator, is seeking a highly skilled and motivated Remote Clinical Research Scientist to contribute to their cutting-edge drug development programs, supporting research remotely from **Delhi, Delhi, IN**. This critical role involves the design, execution, and monitoring of clinical trials, ensuring adherence to regulatory guidelines and scientific rigor. You will be responsible for developing clinical trial protocols, investigator brochures, and case report forms (CRFs). A deep understanding of pharmaceutical sciences, pharmacology, and clinical trial methodologies is essential. You will collaborate with cross-functional teams, including regulatory affairs, biostatistics, data management, and clinical operations, to ensure seamless trial progression. Data analysis and interpretation of clinical trial results, including the preparation of study reports and publications, will be a key responsibility. You will stay abreast of the latest scientific literature and emerging trends in relevant therapeutic areas. The ideal candidate will possess strong analytical and problem-solving skills, with the ability to critically evaluate scientific data and make informed decisions. Excellent written and verbal communication skills are paramount for effective scientific discourse and reporting. This position is fully remote, offering a flexible work environment while demanding high levels of productivity and accountability. You will contribute to the strategic planning of clinical development programs and provide scientific input into regulatory submissions. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is required. A Ph.D. or Master's degree in a relevant life science discipline (e.g., Pharmacy, Pharmacology, Biotechnology) is mandatory. Previous experience in clinical research within the pharmaceutical or biotechnology industry is essential. This is an exceptional opportunity to advance novel therapies and make a significant impact on patient health, working remotely from **Delhi, Delhi, IN**.
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Lead Research Scientist - Oncology Drug Development
302001 Jaipur, Rajasthan
₹150000 Annually
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Posted 12 days ago
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Job Description
Our client is seeking a highly motivated and accomplished Lead Research Scientist to join their cutting-edge pharmaceutical research team, operating on a fully remote basis. This role is crucial for driving innovation in oncology drug discovery and development. You will be instrumental in designing and executing complex research projects aimed at identifying novel therapeutic targets and developing first-in-class small molecule or biologic drugs for various cancer types. This position requires a deep understanding of cancer biology, molecular pharmacology, and drug discovery pipelines.
Key responsibilities include:
The successful candidate will hold a Ph.D. in Molecular Biology, Pharmacology, Biochemistry, or a related field, with a minimum of 7 years of post-doctoral or industry experience in cancer research and drug discovery. A strong publication record and proven success in leading research projects from discovery to preclinical development are essential. Expertise in cancer genomics, immunology, or specific signaling pathways relevant to oncology is highly desirable. Excellent analytical, problem-solving, and communication skills are paramount for this remote role, requiring the ability to collaborate effectively across geographical boundaries. This is a unique opportunity to significantly contribute to the development of life-saving cancer treatments within a dynamic and forward-thinking organization.
Key responsibilities include:
- Designing and overseeing preclinical research strategies for oncology therapeutics.
- Leading a team of scientists in hypothesis-driven research and experimental design.
- Analyzing and interpreting complex biological data to guide project direction.
- Developing and validating in vitro and in vivo models for drug efficacy and safety testing.
- Collaborating closely with cross-functional teams including medicinal chemistry, DMPK, and translational science.
- Identifying and evaluating external research collaborations and technologies.
- Staying abreast of the latest scientific advancements and competitive landscape in oncology.
- Preparing and presenting research findings at internal meetings and external scientific conferences.
- Contributing to the preparation of regulatory documents and patent applications.
- Mentoring and guiding junior researchers.
The successful candidate will hold a Ph.D. in Molecular Biology, Pharmacology, Biochemistry, or a related field, with a minimum of 7 years of post-doctoral or industry experience in cancer research and drug discovery. A strong publication record and proven success in leading research projects from discovery to preclinical development are essential. Expertise in cancer genomics, immunology, or specific signaling pathways relevant to oncology is highly desirable. Excellent analytical, problem-solving, and communication skills are paramount for this remote role, requiring the ability to collaborate effectively across geographical boundaries. This is a unique opportunity to significantly contribute to the development of life-saving cancer treatments within a dynamic and forward-thinking organization.
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Principal Scientist - Drug Discovery & Development
160001 Chandigarh, Chandigarh
₹2800000 Annually
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Posted today
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Job Description
Our client, a leading pharmaceutical innovator, is seeking an exceptional Principal Scientist to spearhead critical drug discovery and development initiatives. This is a fully remote position, allowing you to contribute from anywhere while collaborating with a world-class research team. The ideal candidate will possess deep expertise in preclinical research, target identification, and validation, with a strong understanding of modern drug development paradigms. You will be instrumental in guiding research programs from concept to clinical candidate selection, leveraging cutting-edge scientific methodologies and technologies. This role demands a visionary scientific leader passionate about bringing life-saving therapies to patients.
Responsibilities:
Responsibilities:
- Lead and direct research programs in assigned therapeutic areas, focusing on early-stage drug discovery and development.
- Design and execute complex experiments to identify and validate novel drug targets.
- Develop and implement innovative assay methodologies and screening strategies.
- Analyze and interpret complex biological data, making critical decisions to advance research programs.
- Collaborate closely with cross-functional teams including medicinal chemistry, pharmacology, DMPK, and toxicology.
- Prepare comprehensive research reports, regulatory submissions, and scientific publications.
- Mentor and guide junior scientists and research associates, fostering a collaborative and high-performance research environment.
- Stay current with scientific literature and emerging technologies in relevant therapeutic fields.
- Contribute to the strategic planning and prioritization of the R&D pipeline.
- Present research findings at internal meetings and external scientific conferences.
- Ensure adherence to all relevant safety, ethical, and regulatory guidelines.
- Manage external collaborations with academic institutions and CROs.
- Identify and evaluate potential new research opportunities and technologies.
- Ph.D. in Molecular Biology, Pharmacology, Biochemistry, or a closely related discipline.
- 10+ years of post-doctoral and industry experience in drug discovery and development.
- Demonstrated expertise in at least one major therapeutic area (e.g., oncology, immunology, neuroscience).
- Proven track record of leading successful research projects from target identification through preclinical development.
- Strong understanding of target validation, assay development, high-throughput screening, and in vivo pharmacology.
- Proficiency in bioinformatics and data analysis tools.
- Excellent scientific writing and presentation skills.
- Experience with IND-enabling studies and regulatory interactions is highly desirable.
- Ability to thrive in a fast-paced, dynamic, and remote research setting.
- Strong leadership and team-building capabilities.
- Experience managing CROs and external collaborations.
- Commitment to scientific rigor and innovation.
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8
Principal Scientist - Drug Discovery & Development
208001 Kanpur, Uttar Pradesh
₹2500000 Annually
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Posted today
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Job Description
Our client, a leading biopharmaceutical company, is seeking an exceptional Principal Scientist to join their innovative research and development team. This is a fully remote position, offering the opportunity to contribute to groundbreaking work from anywhere in **Kanpur, Uttar Pradesh, IN**, or globally. The ideal candidate will possess extensive experience and a deep scientific understanding in drug discovery and development, with a proven ability to lead complex research projects from concept to preclinical stages.
You will be responsible for driving key research initiatives, designing and executing experiments, analyzing data, and interpreting results to advance our pipeline of novel therapeutics. This role requires a highly motivated and collaborative scientist with strong leadership skills, capable of mentoring junior researchers and contributing to strategic decision-making. You will leverage your expertise in areas such as medicinal chemistry, pharmacology, molecular biology, or a related field to identify and validate new drug targets and develop innovative treatment strategies.
Key Responsibilities:
Qualifications:
You will be responsible for driving key research initiatives, designing and executing experiments, analyzing data, and interpreting results to advance our pipeline of novel therapeutics. This role requires a highly motivated and collaborative scientist with strong leadership skills, capable of mentoring junior researchers and contributing to strategic decision-making. You will leverage your expertise in areas such as medicinal chemistry, pharmacology, molecular biology, or a related field to identify and validate new drug targets and develop innovative treatment strategies.
Key Responsibilities:
- Lead and manage multiple drug discovery and development projects, setting scientific direction and achieving project milestones.
- Design and execute complex in vitro and in vivo experiments to identify, validate, and characterize novel drug candidates.
- Develop and optimize assays for screening and evaluating compound efficacy and safety.
- Analyze experimental data, interpret results, and draw scientifically sound conclusions.
- Author high-quality research reports, presentations, and manuscripts for internal and external dissemination.
- Collaborate effectively with cross-functional teams, including medicinal chemistry, biology, DMPK, and toxicology.
- Stay abreast of the latest scientific literature, emerging technologies, and industry trends in relevant therapeutic areas.
- Mentor and guide junior scientists, fostering a culture of scientific rigor and innovation.
- Contribute to the strategic planning and portfolio management of the R&D pipeline.
- Present research findings at scientific conferences and to senior management.
Qualifications:
- Ph.D. in Pharmacology, Molecular Biology, Biochemistry, Medicinal Chemistry, or a related life science discipline.
- Minimum of 10 years of progressive research experience in the pharmaceutical or biotechnology industry.
- Demonstrated track record of successfully advancing drug candidates from discovery through preclinical development.
- Expertise in specific therapeutic areas and relevant disease biology.
- Strong knowledge of drug discovery processes, experimental design, and data analysis techniques.
- Proficiency in relevant laboratory techniques and instrumentation.
- Excellent leadership, project management, and communication skills.
- Ability to work independently and as part of a high-performing, remote team.
- Publication record in peer-reviewed journals and experience presenting at scientific meetings.
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