Senior Investigator - Pharmacokinetics

3-7 years

Not Disclosed

Hyderabad

15 June 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

-Designs and conducts absorption, distribution, metabolism and excretion (ADME) research on compounds, drug agents and metabolites in pre-clinical and/ or clinical development. Using a physicochemical approach, attempts to compile various data such as absorption and excretion rates and drug agent halflife in order to establish pharmacokinetic profiles of new chemical and/or molecular entities as well as determining the optimum and safe dosage forms for compounds that have been determined to have indications for various disease groups. Responsible for developing protocols and/or preparing study documentation and findings to support domestic and inte national submissions of new drugs. May include modeling and simulation. May conduct studies using parametric optimization approach. Manages research related to absorption, distribution, metabolism, and elimination of drugs in both animals and humans for a therapeutic area, product line or program. Works closely with toxicology to document drug exposure in safety studies. Conducts bioanalytical research on drug agents and metabolites in clinical studies, including management of studies conducted in outside labs. Using pharmacokinetics, compiles data such as absorption and excretion rates in order to establish optimal and safe dosage rates. Serves as liaison with marketing, conducting analytical and kinetic studies on new dosage regimens and/or new dosage forms. -Associate Director levels:Provides strategic and broad team leadership on drug discovery and/or early development projects and initiatives throughout the lifecycle, and/or leads broad technology development areas within department and Division. Widely recognized as a strong team leader and/or a deep expert in her/his area ; assesses impact, limitations, and added value of scientific activities in order to define team's strategic objectives, advance related projects, and/or significantly expand scientific/technical knowledge within one or several related areas of deep expertise and relevance to Division. -Senior Principal Scientist levels:Establishes and leads novel projects in emerging strategic scientific/technical/development areas. Widely recognized as a key expert in her/his area, develops ideas with team members and collaborates across multiple different therapeutic areas, modalities and/or initiatives. Leads and connects a team to enable project progression, and/or identifies key connection points with own area(s) of deep expertise to progress department and Division strategic priorities. Recognizes and leverages external collaboration opportunities.

About the Role

Your responsibilities include, but are not limited to:

Generates innovative strategy input and project concepts across multiple scientific/technical/development domains.
Develops and leads innovative interdisciplinary teams, and/or leads through the matrix in projects and initiatives using a well‐developed internal and external scientific network.
Conducts long‐ and mid‐ term planning to identify specific, measurable anticipated impact of team objectives or functional community deliverables to Division pipeline and adapts plans based on strategic changes, external forces, and own insights.
Links scientific strategy with specific objectives in novel areas that will lead to fundamental insights or new discoveries, through flexible matrix communities and/or direct team leadership and empowerment, including collaborations with external partners to bring new knowledge into the department/Division.
Develops innovative research, technology and/or early development projects with team, and/or enables internal multi‐disciplinary teams to progress assets through the Division pipeline.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirements:

P&L or Unit Accountability. Collaborating across boundaries. People Leadership.
Chemistry. Clinical Pharmacology. Clinical Research. Clinical Study Reports.
Clinical Trials. Data Entry. Drug Discovery. Due Diligence.
Electronic Components. Gene Therapy. Lifesciences.
Medical Research. Microsoft Office. Modeling And Simulation.
Patient Care. Physics.
Project Management. Translational Medicine.

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network