211 days ago on sjobs.brassring.com

Medical Director/Exec. Director Clinical Pharmacology, TM NIDU

Novartis Pharma Schweiz AG

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Medical Director/Exec. Director Clinical Pharmacology, TM NIDU

Job ID 206749BR Position Title Medical Director/Exec. Director Clinical Pharmacology, TM NIDU Division NIBR Business Unit Translational Medicine Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Join Novartis Translational Medicine NIDU and be part of Novartis global Development efforts to deliver innovative treatments that change the practice of medicine. Those working in NIDU have a broad understanding of medicine and pharmacology, and the team brings forward novel drug mechanisms in emerging disease areas where there are opportunities to help many patients: examples include liver diseases, non-malignant hematology and hearing loss.

You will design and implement strategies for NIDU drug development projects in liaison with appropriate line functions that contribute to clinical pharmacology and profiling studies meeting regulatory requirements (ICH/GCP, Novartis SOPs) leading to the successful registration of new innovative medicines.

- Provide medical and scientific leadership and expertise to all line functions on the study team

- Develop and implement study protocols for different types of clinical pharmacology studies

- Responsible for clinical monitoring and safety data review during and after the interventional phase of a study

- Lead study data analysis, data interpretation and communication of results

- Oversee publication and external presentation of study results

- With support from Head Translational Medicine NIDU and Head Profiling TM, lead the development of the overall clinical pharmacology plan for NIDU programs

- Represent Translational Medicine on Global Project Teams

- Lead the Translational Medicine sub-team of Global Project Teams

- External representative to medically related experts and organizations, advancing the interests of Novartis by your knowledge, style and personal skills

- With support from Biomarker Development, develop and implement biomarker plans on study and disease indication levels

- Lead the preparation of the clinical pharmacology portions of submission dossiers with support from Head Translational Medicine NIDU and Head Profiling TM

- Provide support for dose selection, design and other clinical pharmacology matters for First in Human studies

- Represent Translational Medicine in Health Authority interactions and briefing documents preparation

- Work independently to develop and implement study design and collaboratively with the other NIDU physicians on the broader clinical indication strategy

- Champion and drive new clinical compound characterization opportunities and profiling approaches

- Be a recognized expert in your field, driving success for individual studies and projects; respected by colleagues across Novartis R&D and externally; working globally across various Novartis Institutes and Divisions.

People leadership: matrix program team 5-8 cross-functional members from Translational Medicine and other line groups

Financial responsibility: Indirect responsibility for study budgets

Impact on the organization: Design and implementation of studies according to the Clinical Pharmacology Plan, enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds.

About Translational Medicine Profiling

Profiling of an investigational therapy is essential to its successful development. Among other things, Profiling activities are important to select and justify doses and dosing regimens, assess risks and benefits in special patient populations, assess possible drug-drug interactions and identify compound differentiation opportunities. Additional efforts may include clinical mechanistic studies and exploratory studies to evaluate unexpected safety or efficacy signals that are observed clinically.

The Translational Medicine Clinician is a critical link on the Novartis global project teams between the non-clinical and clinical sciences and Profiling underpins everything we do in the development of new therapies. Regardless of whether a new drug candidate is designed to treat a rare or common disease, serious or non-serious, the characteristics of the therapy itself will always need to be learned and the factors that affect variation among individual patient responses to that therapy understood. True understanding of the properties of a novel compound requires collaboration among all the team members, to combine complex quantitative analyses of exposure and response with empiricism and clinical judgment, to help ensure successful compound development.
Minimum requirements Your education and experience:

- Medical degree

- Board Certified Clinical Pharmacologist or equivalent level via significant training and clinical pharmacology experience

- Specialty training in hepatology or endocrinology preferred

- Experience performing a similar role within a Pharmaceutical research company leading cross-functional/matrix global project teams strongly preferred. Alternatively, significant relevant experience from a Clinical Research Organization or academic medical center combining relevant scientific and medical subspecialty skills, translational expertise, and clinical trial conduct, partnering with Sponsor international Pharmaceutical firms

- Significant contributions to your field over time, creating or implementing clinical innovations that are recognized by medical experts and ideally documented by peer-reviewed publications

- Fluent written and spoken English

Your behavioral characteristics:

- Strategic thinker: you have created major innovations, networked with and influenced external medical leaders with your clear and logical presentation of complex strategic issues

- Results-driven self-starter and decision taker

- Strong cooperative team player, flexible in a changing environment

- Good planning, prioritization, problem solving and organizational skills

- Resilient, energetic, optimistic and enthusiastic; responding constructively to challenging new ideas and input