Senior Director Medical Dermatology Stiefel GSK Collegeville

Job description
This position reports to the Vice President Global Clinical Development for R & D Dermatology. The Medical Director/Senior Medical Director has Physician Project Leader (PPL) role accountabilities at Stiefel and will be responsible for providing leadership and guidance on clinical development programs. The role includes responsibility for steering the scientific and clinical strategy for dermatology assets in early discovery through approval, as well as providing technical expertise to the organization in the areas of patient safety, clinical research, and scientific communications. This position requires strong technical, strategic, organizational and communication skills.


The Key Elements Of The PPL Role Are

• To provide Clinical Leadership, Disease Area Expertise, and Prescriber Insight for an asset in development or a marketed product
• To provide Medical Governance for an asset in development or a marketed product with specific accountability for governance of clinical research and a global viewpoint of safety and efficacy throughout the entire lifecycle of a medicine, working with the SDL ( Safety Development Leader) accountable for Pharmacovigilance and the GML( Global Medical Affairs Leader) accountable for Medical Information and Promotional Practice
• To provide single point of accountability for the end to end Clinical Development Plan for as assets in development.
• To act as Data Steward of the clinical data for an asset in development or a marketed product
To work in partnership for all of the above with the Safety Development Leader (SDL) and the Global Medical Affairs Leader (GML), and accountable to the Medicines Development Leader for development assets and marketed products

The PPL Must Be Able To Demonstrate The Following Technical/functional Competencies

• Clinical Development Expertise - Demonstrates an understanding of the required steps to progress a new chemical entity (NCE) through clinical trialstages through submission. Has demonstrated experience in the design, development, execution, statistical analysis, clinical interpretation and reporting of high quality clinical studies.
• Good Clinical Practice Knowledge - Demonstrates the ability to ensure an investigation is conducted according to applicable Good Clinical Practice regulations and internal control documents, in order to protect the rights, safety, and well being of subjects and the accuracy and validity of the trial data. Ensures the study is in a continuous state of inspection readiness.
• Clinical Judgment Experience - Has demonstrated a proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOP(s).
• Scientific & Medical Knowledge - Demonstrates a current, in-depth understanding of the relevant drug and associated therapeutic and disease area.
Clinical Data Stewardship – Demonstrates an understanding of the critical importance of rigorous data generation and disciplined stewardship of the data
• Medical Monitoring / Pharmacovigilance – Demonstrates an understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. Knows when to involve the Safety Development Leader for escalation e.g., to the Chief Medical Officer, Global Safety Board
• Reimbursement / Market Access Knowledge
Demonstrates a thorough understanding of the attributes of a medicine that are likely to be valued by payers, and the evidence required to support the payer value proposition. Understands the importance of designing and executing the trial to achieve future marketing authorisation.
• Scientific Writing - Demonstrates the ability to produce written scientific communications with clarity, accuracy and rigour and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange
• Scientific Presentation – Demonstrates the ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.
• Business Acumen - Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D.
• Strategic Thinking – Maintains competitive advantage by ensuring the application of the principles, tools and systems from Simplifying Clinical Development.
• Project Management - Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics.

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