Apr 28, 2022

Job Description

30 million! That is the estimated number of patients worldwide suffering from inflammatory arthritis. Join Novartis to help find the right drugs that transform and improve patients' lives all around the world.

You will join an international team of clinicians and scientists making significant impact on autoimmune diseases with high unmet medical need, taking new medicines into early-stage clinical trials: in many cases you will be the first to witness the effectiveness of a new medicine that may transform the lives of millions. Your medical and scientific leadership / expertise will significantly impact the Novartis autoimmune drug development pipeline.

You will be responsible for leading a comprehensive Clinical Pharmacology strategy for the Autoimmunity, Transplantation & Inflammatory Disease (ATI) portfolio. In devising the clinical pharmacology strategy, you will be responsible for identifying and making critical decisions which will require the balancing of optimizing speed with minimizing risk. You will also provide scientific expert assessments and support for in-licensing opportunities, including due diligences. As such you will possess outstanding experience in the field of clinical pharmacology and be abreast of all the latest developments and trends in this space.

Your responsibilities will include:
1. Translational Medicine/early-stage clinical projects:
• Develop and deliver high value clinical pharmacology decision strategies for the Translational Medicine component of drug development projects from Research to Clinical Proof of Concept or Proof of Mechanism in a single or multiple indication, including parallel indication expansion Proof of Concepts.
• Develop and implement clinical pharmacology and biopharmaceutic study protocols for different types of studies including bioequivalence, bio-comparability, drug-drug interaction, ADME, PK/PD TQT, hepatic impairment and special population studies, and other documents such as Investigator Brochures.
• Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study.
• Represent Clinical Pharmacology aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups) and responsible for integrating results into regulatory filings.
• Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches.

2. Translational Medicine/late-stage clinical projects:
In collaboration with the respective Translational Medicine Therapeutic Area Head:
• Responsible for implementing studies during the Proof-of-Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof-of-Concept studies.
• Communicate clinical team matters to Global Project Teams, relevant NIBR and Global Drug Development committees, and other Novartis Boards as required.
• Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders.
• Matrix people responsibility per project; 5-8 cross-functional members from TM and other line functions per project team.

Impact of this role?
• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof-of-Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions.
• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds.
• As an established leader and recognized specialist/subject matter expert in the field of clinical pharmacology, drive the project team clinical pharmacology strategy. Work globally across various Novartis Institutes and Divisions as well as country organizations as appropriate.

Diversity & Inclusion / EEO

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

Minimum Requirements

This position is written for Executive Director - we can hire at Director level for those with careers that include less established science / clinical study experience. We support International family relocation and integration support to Switzerland.

What you’ll bring to the role:

• Medical Degree with post-doctoral and / or specialized further training and experience in Clinical Pharmacology, ideally board certified in Clinical Pharmacology. Strong understanding of basic science and preferably with PhD. Experience in the immunological therapy area would also be preferable.
• Extensive experience in a clinical pharmacology capacity in the biopharmaceutical industry leading early phase clinical trials or in CRO/specialist early phase CRO. If from the latter, responsible for managing the medical relationship with Sponsors.
• Strong quantitative pharmacology skills and expertise in Translational Medicine applied to immunology.
• In depth knowledge of regulatory requirements for pharmacology section of submission documents and ideally experience of being Pharmacology Lead for NDA/BLA submission(s).
• Strong scientific reasoning and agile decision-making with ability to apply judgement to balance risk, rigor and speed.
• Highly collaborative with excellent interpersonal, communication and presentation skills.
• Record of high-quality publications in international scientific journals.
• Business fluent in English (written and spoken).

Your behavioral characteristics
- Demonstrated passion for treating patients and science
- 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

Translational Medicine is a global group of scientists and physicians working at the pre-clinical and early clinical stage of drug discovery. Our Physician-Scientists drive innovative and cutting-edge science through the selection, profiling and effective global development of successful medicines, integrating clinical science into the discovery and preclinical development phase. Our Translational Medicine concepts are driven by medical needs of patients and the concept of personalized medicine, tailoring the drug, dose and dosing regimen to the patient so the clinical response is optimal in efficacy and safety.

We focus from identification of drug targets (molecular pathways relevant to disease) up to the completion of Proof of Concept (Phase IIa studies). Our Translational Medicine Experts are part of preclinical project teams in all drug discovery phases and help design the pathway for First in Human studies (healthy volunteer) that bridge to studies in the patient population. They have the comprehensive responsibility for designing and executing the early clinical drug development phase with a project team including research, biomarkers, biostatistics, modeling & simulation, toxicology, technical experts and clinical trial teams.

Why consider 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!
Translational Medicine
Research & Development
Full Time
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Executive Medical Director (Clinical Pharmacology - ATI)

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