Scientist, Pharmacokinetics and Pharmacometrics - Hyderabad

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Pharmacokinetics & Pharmacometrics Job Category: Scientific/Technology All Job Posting Locations: Hyderabad, Andhra Pradesh, India Job Description: Scientist, Pharmacokinetics and Pharmacometrics - Hyderabad Position Summary: The Clinical Pharmacology (CP) PK Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for (in collaboration with the Clinical Pharmacology Leader), the following activities of end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1 studies including: protocol development, pharmacokinetic/pharmacodynamic data analyses, and generating the in-text tables, figures and PK/PD attachments for Clinical Study Reports (CSR) and CP CSR section writing, as well as study summary contributions to CTD documents. Additional responsibilities include the support of all other studies in any phase of development which include noncompartmental analyses (and all associated activities). Principal Responsibilities: • For Phase 1 clinical pharmacology trial protocols, author the CP sections of the protocol, coordinate the overall development of the protocol, and ensure timely approval and issuance of the document. • Provide QC review of protocols written by others, including other PK Scientists. • Review non-compartmental analysis (NCA) trial specific data transfer agreements (tsDTA) for the creation of PK/PD analysis datasets. • Create the Clinical Pharmacology Analysis Plan based on the protocol. • Perform pre-database lock, interim, and final NCA for trials in all phases of drug development. Prepare the final NCA output including in-text tables and graphs (and PK/PD attachments) for the CSR. • Create a logbook with data handling rules for review by the Clinical Pharmacology Leader prior to conducting the final analysis. • Perform QC for analyses performed others, including other PK Scientists. • Develop the CP sections of CSR for trials, and facilitate a timely review and approval of those sections. • Perform CP section CSR review and QC for other PK Scientists. • For regulatory submission documents (e.g., NDA, sNDA, MAA, Type II variation etc.), provide tables and figures for study-specific summaries and if necessary, support the development of other PK/PD related sections. • Establish and maintain excellent/cooperative relationships with other departments (Data Management, BDDS, Regulatory, etc.) to facilitate the on-time (or expedited) deliverables. • Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles. • Ensures all study documentation generated by CPP are properly managed and maintained on the CPP Repository, and are ultimately submitted for long-term storage in archival per Johnson & Johnson Record Retention Schedules. • Propose efficiencies for CPP processes (including AI solutions) Principal Relationships: This role reports into and receives their assigned activities and responsibilities from the Scientific Process Lead. Functional contacts within CPP include but are not limited to: CP Leaders, CP TA Project Leads, and CP TA Group Heads. Functional contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Biostatistics, Clinical, Global Medical Safety, Statistical Programming, Clinical Programming, BDDS Representative, Data Management, and Operations. External contacts include but are not limited to external partners (e.g. PK Office Vendors). Education and Experience Requirements: · Bachelor’s degree or higher and / or equivalent preferably with science background. Up to 2 years of relevant work experience. Experience and Skills Required: Basic knowledge of PK, PD, and statistical principles. · Working knowledge of Microsoft suite of software products. · Hands-on experience with Phoenix WinNonlin and R is preferred. · Good oral and written communication skills. · General understanding of overall process of drug development and the overall pharmaceutical R&D process is preferred Other: · Estimated both domestic and international travel of about 5% of time. · Contribute to preparation of IB, INDs, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs. · Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals. · Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact. Required Skills: Preferred Skills: Analytical Reasoning, Clinical Data Management, Clinical Operations, Clinical Pharmacology, Data Savvy, Detail-Oriented, Drug Discovery Development, Execution Focus, Pharmacokinetic Modeling, Pharmacokinetics, Pharmacometrics, Regulatory Environment, Relationship Building, Report Writing, Scientific Research, Study Management, Technologically Savvy