Berufsbezeichnung:
Senior Director – Research & Development (Proprietary Products)

Arbeitsbeschreibung:
1. Responsible for Execution of In-house and In-licensed R&D Programs to Ensure Timely Product Approvals and Launch as per the Development Plan: - Playing the role of Project Champion/Leader and taking decisions connected all developmental activities of the programs such as pre-clinical, clinical development to ensure timely progression of the R&D programs. - Coordinating with internal and external team for various other functions connected with the program/product development. - Coordinating with CRO/CMOs to ensure manufacturing supplies as needed - Work with the regulatory team to establish/develop regulatory strategies in order to obtain regulatory approvals - Representing project committees, joint steering committees of all collaborated projects with external partners - Responsible for monitoring and managing project budgets and financials connected with the project. - Execution of project contracts and agreements, engaging service providers. 2. Pre-clinical (animal) Pharmacokinetic (PK) and Toxicokinetic (TK) Studies Conducted for Proprietary Products - Overall accountability for strategy, design and approval of study protocol, CRO selection, study award and financial approvals. - Ensure appropriate interpretation, quality and timelines of study results and delivery of reports. - Review and finalization of pre-clinical PK/TK inputs for 505 (b)(2) IND, NCE-IND& NDA submissions modules and respond to any queries/comments from regulatory agencies. 3. Phase 1 Pharmacokinetic (PK) Studies Conducted for Proprietary Products - Overall accountability for design and approval of study protocols, CRO selection, study award and financial approvals. - Ensure appropriate interpretation, quality and timelines of study results and delivery of reports. - Review and finalization clinical PK inputs for 505 (b)(2) IND, NCE-IND& NDA submissions modules and respond to any queries/comments from regulatory agencies 4. Pharmacokinetic and Pharmacodynamics (PK/PD) Modeling and Simulations (M&S) - Provide PK/PD modeling and simulation support for evaluating product concepts, developing target product profiles (TPP), translation from animal to human proof of concept studies (POC) and design of Phase 1 and late-stage clinical trials - Proactive adoption of Quantitative Pharmacology (CQ) tools to support R&D of proprietary drug products 5. Bioanalysis for Proprietary Products - Ensure that team member(s) coordinate with CROs for bioanalytical method development (of new methods), troubleshooting, review of validation plans and monitor validation activities (for GLP studies) - Approve validated method and final bioanalytical validation reports - Responsible for selection ensuring quality and timely delivery of bioanalytical data. 6. Improve Quality Systems in Functional Operations - Identify key areas of functional SOP requirement, approve and implement SOPs and other quality systems in coordination with the DQA team. 7. Develop ownership and support the cause of organizational initiatives - Proprietary Products Groups (PPG) representative to various initiatives

Angestelltenname: Dr. Reddy's Laboratories SA

Arbeitgeber-Adresse:
Dr. Reddy's Laboratories SA Elisabethenanlage 11 4051 Basel

Form von Kontakt: Vishwas Muthyala

Arbeitgeber Telefonnummer: +41 61 561 68 00

Stellenkurzbeschreibung: Akademische Berufe

Land: Schweiz

Region: Basel-Stadt

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Keine Angabe

Erfahrung: 5 Jahre und mehr

Quelle des Stellenangebots:
SECO,Öffentliche Arbeitsverwaltungen, Schweiz (Confoederatio Helvetica)

Fahrerlaubnis: Nein

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: CHF

Gehaltsperiode: Gehalt Periode nicht spezifiziert

Gehalt Besteuerung: brutto