This role requires relevant skills sets to toxicology pathology research and act as study pathologist for toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.
What are the key responsibility of the role?
- Monitoring, planning and designing regulatory and Non-Regulatory Toxicity and Safety Studies in Rodents and Non-Rodents Species.
- To conduct long term toxicity studies (7/14/28/90 Days and 6 months) including carci study studies by different routes of administration viz. Oral (gavage), Intraperitoneal, Intravenous, Subcutaneous, Intramuscular, Intradermal, dermal application, Inhalation, Intra-tracheal, Intravaginal, etc. in rodents (rat, mouse, hamster, guinea pig) and non-rodents species (rabbit and dog).
- To perform work in compliance with the OECD principles of Good Laboratory Practice.
- Ethics Protocol, Study Plan, Standard Operating Procedure (SOP) and Formats for respective studies preparations as per GLP (Good Laboratory Practice).
- Support in literature search for ongoing projects
- Due diligence of in-licensing projects
- Maintain instruments used routinely in toxicity studies as instrument in charge.
- Training and mentoring of team members
- Provide scientific inputs on matter related to toxicology
- Lead discovery or similar projects, coordination with stakeholders and completion of task as per agreed timelines
- To prepare and review SEND documents for different SEND domains for toxicity studies
- To participate intra/inter departmental meetings, project review meetings and present/discuss data pertaining to toxicology
- To provide administrative support to senior management team/department head
- Preparation and review of IB, IND and NDA documents for regulatory submission
- M. Sc. /M. Pharm /Ph. D with 8 to 14 years of relevant experience
- Knowledge and experience of toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.
Job Features
| Job Category | Drug Discovery & Preclinical Development |
| Job Category | Partnerships & Portfolio Strategy |
This role requires relevant skills sets to toxicology pathology research and act as study pathologist for toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.
What are the key responsibility of the role?
- Manage these teams and run day to day operation for these areas
- Training and mentoring of team members
- Plan and prioritize histopathology work to complete within agreed timelines
- Perform necropsy, gross pathology, histopathology in rodents and nonrodent toxicology studies
- Act as study pathologist for toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.
- Prepare and/or review histopathology reports, correlation and discussion of histopathology findings in relation to clinical pathology data and/or in-life parameters
- Peer review of toxicity study histopathology slides/data
- Provide scientific inputs on matter related to toxicology/toxico-pathology
- Lead discovery or similar projects, coordination with stakeholders and completion of task as per agreed timelines
- To prepare and review SEND documents for macroscopic and microscopic domain for toxicity studies
- Standardization and/or validation of special staining techniques and including IHC
- To participate intra/inter departmental meetings, project review meetings and present/discuss data pertaining to toxicology/toxico-pathology
- To write, review and implement SOPs related pathology/histopathology and overall compliance of GLP for the activities related to these areas
- To provide administrative support to senior management team/department head
- Preparation and review of IB, IND and NDA documents for regulatory submission
- M. V.Sc with 8 to 10 years in related field
- Experience in toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.
Job Features
| Job Category | Drug Discovery & Preclinical Development |
| Job Category | Partnerships & Portfolio Strategy |
What are the key responsibility of the role?
- EHS operation for R&D Tandalja, Makarpura & Savli
- Co-ordinate with R&D labs and other departments.
- To carry out the ETP operation and inspection on a daily basis, initiating data as per the GPCB norms and to ensure the effective operations.
- Ensuring the GPCB effluent parameters pH, BOD, COD, TDS, TSS and other parameters are compiled as per GPCB CCA.
- Safe disposal of Solid waste, liquid and biomedical waste and preparing manifest in GPCB Xgn.
- Preparing and maintaining ETP log sheet, legal compliance records – Monthly Patrak, Form 4, Form 5 of Form 9, 10, &11, Form 32, Form 33, Form 36, Accident Register, Form 29 as per DISH.
- Preventive Maintenance of ETP and Fire Fighting system.
- Conducting Plant safety survey, Safety Toolbox talk and Safety survey in plant.
- Conducting Safety Committee and BMW committee
- Responsible and conducting Safety Risk assessment and Safety Audit.
- Issuance of Work Permit
- EHS SOP implementation and ensuring its compliance in the premises.
- EHS Trainings to employee and contract workers
- Coordinating with DISH and GPCB for the timely compliance and also timely answering of query /noncompliance from these authorities.
- B.Sc. / M.Sc. in Environment Science + PDIS (Post Diploma in Industrial Safety) with 8 to 10 years of relevant experience.
- Knowledge and experience of handling biomedical wastes, PESO guidelines and legal compliances.
Job Features
| Job Category | Drug Discovery & Preclinical Development |
| Job Category | Partnerships & Portfolio Strategy |
Role that requires relevant skills sets to support handling of multiple cell lines, culture maintenance, and other research and development activities for multiple programs. Should have basic knowledge and hands on experience on molecular biology techniques to support projects. Additionally, the incumbent would be required to maintain inventory of consumables and reagents used routinely and pro-actively manage sourcing/ordering, follow-up to ensure adequate availability of items.
What are the key responsibility of the role?
- Handling and maintenance of multiple mammalian cell lines under aseptic conditions as per project requirements
- Preparation of experimental SOPs, documentation of experimental findings in LNBs/ELN. Work as a team towards accomplishing project goal
- Hands on experience for basics molecular biology and protein techniques like – PCR, Agarose gel electrophoresis, SDS-PAGE, BCA/Bradford based protein estimations, western blot etc.
- Plan and scale up cell cultures to meet experimental requirements for assay development/screening in 96/384 well plate
- Troubleshooting with guidance from reporting manager
- Maintain and regular update of lab inventory, assist team members in procurement related activities.
- M.Sc. with 1 to 3 years of relevant experience
- Experience in handling cell cultures (Mammalian, Insect and bacterial), Phase contract microscope, cell counter aseptic workflows, SDS-PAGE, electrophoresis etc.
Job Features
| Job Category | Drug Discovery & Preclinical Development |
| Job Category | Partnerships & Portfolio Strategy |
Act as point of contact from clinical operations for assigned trials and management of assigned projects from start up till close out
What are the key responsibility of the role?
- Plan study activities and timelines to share with stakeholders, set up tracking tools for assigned trials & assess progress as per pre-set timelines.
- Prepare & obtain approval for clinical trial budget and for any change in the budget during the study.
- Participate in vendor selection. Oversee & assess vendor performance, Vendor management.
- Co-ordinate finalization of IP label & requisition. Forecasting of IP requirement during the study and prepare IP requisition.
- Train study team on trial documents, processes & assigned SOPs.
- Arrange/Participate in kick-off meetings.
- Prepare/Review study plans & oversee compliance.
- Plan and conduct IM if required.
- Tracking of project finance & project milestones.
- Meet investigators and key opinion leaders for assigned trials.
- Drive subject recruitment for assigned studies and meet predefined timelines.
- Oversee & track regulatory & GCP compliance.
- Coordinate with cross functional groups for required deliverables
- M. Pharm / MSc and MBA will be preferred
- 12 to 15 years of experience as a clinical professional
- Minimum 3 years of clinical project management experience
Job Features
| Job Category | Clinical Development |
| Job Category | Partnerships & Portfolio Strategy |
To support the Clinical Lead in ongoing and upcoming Immunology clinical trials by performing required data compilation, literature search, ongoing review of critical data elements and management of study document folders.
This position will be responsible for review and compilation of critical data from clinical studies, supporting development and management of medical documents, literature search and assist the clinical leads.
What are the key responsibility of the role?
- Assist Clinical lead in literature search and preparation and/or review of documents like CRO proposals, patient diaries, scales, ICF, eCRF etc
- Assist the clinical lead in interactions with KOLs and advisory boards, track the interactions and hours utilized for the various KOLs
- Assist the clinical Lead in ongoing review of the data entered in the EDC and received from CROs and operations team in the form of email updates, lab reports, listings etc
- Organize and maintain study level scientific documents in common folder for easy access
- Prepare slide decks, spreadsheets and documents for presentation of study updates in cross functional and project review meetings
- Coordinate with CRO and clinical operations teams on data quality issues
- PhD/BDS/BAMS/BHMS
- 1 to 2 years of experience in related field
- Technical Skills/Competencies (Software packages, experience with specific machines etc.)
- Reasonable knowledge of MS word/PowerPoint/excel/ reasonable competency in handling computers/laptops
Job Features
| Job Category | Clinical Development |
| Job Category | Marketing |
This role will perform all statistical programming activities includes but not limited to CDISC SDTM and ADaM programming; creating summary reports, tables, listings and figures and adhoc programming activities.
What are the key responsibility of the role?
- Review Study documents and provide inputs from programming perspective that includes but not limited to Study Protocol, eCRF (electronic Case Report Form), Data Management Plan, Data Transfer specifications, Statistical Analysis Plan (SAP) and any other documents necessary to perform programming.
- Ensure that the raw datasets are properly converted to CDISC SDTM formats by either creation or review of the programming performed by a CRO.
- Prepare or review data definition documents such as define xml, SDTM annotated CRF and SDRG in order to compile a “submission ready” data package for regulatory submission.
- Perform programming of CDISC ADaM (Analysis Data Model) and Tables, Figures and Listings defined by the SAP along with any other type of report programming necessary for the study team to meet objectives.
- Assist Sr. Manager Programming in creation and maintenance of department procedures: Participate in departmental initiatives related to process building and improvement.
- Work within SPARC, as necessary, to implement global programming and statistical analysis procedures, processes and standards.
- Coordinate with Cross-functional teams for setting programming deliveries expectations.
- M.Sc/B. Tech/M. Tech
- 6 to 12 years of experience in related field
- Expert in SAS/Statistical programming with demonstrated experience using Base SAS, SAS Stat, Reporting and Graphical Procedures, Macro, SAS Version 9.2 or higher in a clinical trials setting.
Job Features
| Job Category | Clinical Development |
| Job Category | Marketing |
We are looking for a qualified and experienced clinical pharmacologist to join our team and contribute to the development and evaluation of new and existing medications. As a clinical pharmacologist, you will be responsible for designing, conducting and analyzing clinical pharmacology studies, as well as providing expert advice on pharmacokinetic and pharmacodynamic aspects of drug development and regulatory submissions.
We are also looking for someone who has done renal impairment, hepatic impairment, drug-drug interaction, transporter, QT prolongation, biomarker. The Clinical Pharmacologist needs to have non-generics experience.
What are the key responsibility of the role?
- Plan and direct clinical pharmacology studies in collaboration with internal and external partners
- Apply pharmacokinetic and pharmacodynamic modeling and simulation techniques to optimize study design, data analysis and interpretation
- Use biomarkers and intermediate clinical endpoints to support dose selection, efficacy and safety assessment of drug candidates
- Prepare and write clinical study protocols, reports and regulatory documents in compliance with relevant guidelines and standards
- Communicate and present clinical pharmacology findings and recommendations to internal and external stakeholders
- Work across a variety of functions involved in drug development, such as preclinical, clinical, regulatory, biostatistics and medical affairs
- Work across international time zones to coordinate with global teams and vendors
- A Ph.D., Pharm.D. or M.D. degree in clinical pharmacology or a related field
- At least 12-14 years of experience in clinical pharmacology research in the pharmaceutical industry or academia
- Knowledge of biomarkers and intermediate clinical endpoints and their use in drug development
- Proficiency in pharmacokinetic and pharmacodynamic modeling and simulation software, such as Phoenix WinNonlin, NONMEM or R
- Experience in preparing and writing clinical study protocols, reports and regulatory documents, such as INDs, NDAs or BLAs
- Excellent communication, presentation and interpersonal skills
- Ability to work independently and collaboratively in a multidisciplinary team
- Ability to work under pressure and meet deadlines
Job Features
| Job Category | Clinical Development |
| Job Category | Clinical Development |
Drop in your resume at hrd@sparcmail.com to step up your career with Sparc
and we can collaboratively explore opportunities together!