Professional Medical Representative

Job description

Job Description

Clinical Science and Innovation (CS&I) is a group of international clinical scientists leading all early phase clinical trials conducted by Translational Medicine (TM), ensuring they run smoothly, on time and with the patient's interests at center-stage. The team has charge of all First-in-Human trials to test safety, tolerability and exposures, and Proof-of-Concept trials. These form the basis for Novartis' larger decision whether to invest in Phase 2b and Phase 3 studies involving hundreds or thousands of patients.

The CS&I group continues to conduct studies to further profile the compounds as they move through later phases of development to registration and beyond. This includes clinical methodology and pharmacokinetic studies designed to provide additional scientific and mechanistic understanding and support drug label claims

This is a Talent Pooling advert for Early Phase Clinical Trial Leaders interested in future 18m contract positions in the CS&I team. The contract works on-site in CS&I through SDE Services.

YOUR ROLE
You will partner with MD PhD Translational Medicine Experts and lead the planning and implementation of all operational aspects of Early Phase Translational Medicine studies (e.g. highly complex patient / mechanistic studies) from synopsis to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures). Responsible for project level activities through your role as Lead Clinical Scientist, you will implement the TM portion of the Clinical Development Plan for your projects.

• Regular project updates, chair Translational Medicine sub-team meetings, support the operational implementation of the Clinical Development Plan TM portion

• Accountable for project specific standards (e.g. CRFs, outsourcing specifications, data monitoring and validation plans) being developed and applied across all trials to ensure consistency of clinical dossier

• Project manage high complexity studies. Lead and matrix manage the global multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT meetings, report study progress and issues to Management, lead trial level interactions with internal line functions and external CROs

• Prepare studies for Full Development and TM related submission documents

• Write clinical protocols and related documents: lead protocol development process including driving new science by incorporating innovative designs; contribute to the operational and scientific input for development of trial-related documents and processes in other line functions

• In collaboration with MD PhD Translational Medicine Experts and CTT, lead the clinical trial data ongoing medical/scientific review, analysis and interpretation including development of first interpretable results, clinical trial reports, publications and internal/external presentations

• Contribute to development of clinical sections of regulatory documents including Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions

• Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients and develop effective working relationship with key investigators to optimize scientific quality/innovation of clinical study design, execution, reporting and publication

• Implement best practices and standards for trial management

• Provide expertise to other departments and line functions e.g. CQA, Drug Metabolism and Pharmacokinetics, Drug Supply Management and cross-functional working groups

• Contribute to talent and career development of staff through active participation in onboarding, training and mentoring activities

• Order and manage clinical trial materials including drug supplies, CRFs and TMFs

• Identify sites and manage study set-up, including responsibility for Initiation meeting

• Support study related questions such as trial procedures and subjects eligibility

• Regularly update all trial information databases to manage accuracy of information

• Approve center payments

Desired profile

EDUCATION
• Relevant life sciences degree - PhD, PharmD., MSc or BSc

• Fluent English (oral and written), knowledge of a second language is desirable.

EXPERIENCE
• Strong recent early phase Clinical Trials management experience in mid-large Pharmaceutical Industry running multi-site, multi-country, multiple trials. Additional later phase experience additionally useful

• Demonstrated experience leading operational tasks within a multidisciplinary organization, supported by your credible understanding of the science

• Proven ability to manage projects with multiple parallel activities, leading global trial teams and cross functional project teams

• Understands drug development in Early and Full Development

• Full Trial management expertise from set-up and protocol writing to closure

• A results-driven self-starter and decision taker; open, confident and persuasive, succeeding through influence

• A creative and innovative approach with a sharp and objective intellect, experienced in balancing big picture thinking with detailed analysis

• Strong cooperative team player, ability to be flexible and adapt to a changing environment

• A commercial outlook; used to helping a business achieve its objectives

• Well developed interpersonal skills with good presence; experienced presenter & communicator

• Good planning, prioritisation, problem solving and organisational skills

• Resilient, energetic and enthusiastic; responding constructively to challenging new ideas and inputs