Scientist - DMPK Aurigene Oncology Limited

2.0 - 14.0 years

0 Lacs

karnataka

On-site

As a candidate for the position, you should possess a M. Pharm (Pharmacology/ Pharmaceutical Analysis) or M.Sc. (Biochemistry/ Pharmaceutical Chemistry) degree with 11-14 years of experience or a Ph.D. with 2-5 years of experience in the fields of large molecule/ADC PK and bioanalysis. Your expertise should include Antibody Drug Conjugate characterization and bioanalysis, mass spectrometry-HRMS, Q-TOF, and Triple quad. Your role will involve being an expert in designing and executing DMPK studies to support antibody-drug conjugate (ADC) and monoclonal antibody (mAb) programs, ranging from discovery to IND-enabling stages. You should have extensive experience in quantifying biologics such as antibodies, therapeutic proteins, ADCs, and peptides using LC-MS/MS, MSD, and ELISA platforms. Proficiency in advanced bioinformatics tools like BioPharma Finder, MaxQuant, Spectronaut, and other relevant analytical software is essential. Your responsibilities will also include applying innovative techniques for identifying and selecting ADC and mAb lead candidates based on their functions, with a strong emphasis on DMPK profiling to ensure the safe and effective development of therapeutics. You should be adept at interpreting complex DMPK data and providing actionable insights to cross-functional project teams. Active representation of DMPK functions in internal and external meetings to promote collaboration and strategic alignment is crucial. Collaboration with cross-functional departments to address ADC-related challenges and provide integrated solutions from target validation to IND submission will be part of your role. You will be accountable for authoring and reviewing SOPs, study protocols, reports, and regulatory documentation to support both GLP and non-GLP studies. A strong foundational knowledge of DMPK principles including PK/PD, toxicology, and translational sciences is required. Demonstrated capabilities in communication, innovation, and team leadership will be essential for success in this position.,

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Senior Statistical Programmer/Principal Statistical Programmer CPVIA

5.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

Company Description CPVIA is a clinical data analytics solutions company based in Hyderabad (India) specializing in statistical programming outsource and statistical consulting services. Our experienced and expert team focuses on accelerating drug development activities across therapeutic areas with increased quality and optimum cost for pharmaceutical, biotechnology, and medical device companies. Role Description This is a full-time on-site role for a SeniorPrincipal Statistical Programmer at CPVIA in Hyderabad, with flexibility for remote work. The Principal Statistical Programmer will be responsible for statistical programming, data management, creating macros, and providing statistical expertise for various therapeutic areas. Qualifications Minimum 5 years of experience for Senior and 10 years of experience for Principal role in Statistical Programming for clinical trails using SAS Experience on R (especially admiral package) is mandatory as per the client request Data Management and Macro skills Experience in CDISC Data Standardization (SDTMs), ADaM and TLFs Experience in ADaM, TLFs Experience in creating Graphs using SAS or R Experience in (early phase studies, ideally PK/PD, biomarker) or HIV Therapeutic Area is desired. Ability to work independently and collaboratively Strong analytical and problem-solving skills Excellent communication and organizational skills Bachelor's or Master's degree in Statistics, Computer Science, or related field Willing to work in UK/US time zones and the job is based in India How To Apply If you met all the mentioned qualifications above, please send your resumes to info@cpvia.com,

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