Dir ector;Clinical Research-Clinical Pharmacology

Job Summary This is a strategic role within Clinical Pharmacology, involved in all phases of the Product but primarily in program design to the Proof of Concept milestone and design of the clinical pharmacology package through registration and commercialization.

The job role encompasses the following elements:
7 Design a program of clinical studies to take emerging products to the Proof-of-Concept milestone in a rapid and efficient manner and thereafter contribute to the Experimental Medicine package to meet regulatory and commercial needs.
7 Provide expert Clinical Pharmacology input and advice in all Discovery and Development phases of the project and in marketing support.
7 Be a key link between Clinical Pharmacology, Discovery Medicine, Clinical Science, other Clinical R&D functions, Therapy Areas, Discovery, Regulatory, and Product Strategy and Licensing.
7 Be accountable for signing-off relevant sections of key documentation for which the Scientific or Medical Adviser have the necessary professional qualifications and authority.

ACCOUNTABILITIES:
7 Accountable for the scientific content of the Clinical Pharmacology section of the Clinical Development Plan (CDP) and regulatory documentation and, as primary author, contribute to, review, approval and sign-off of Clinical Pharmacologysections of regulatory documents and Clinical Pharmacology manuscripts for publication.
7 Accountable for Safety Statements within Clinical Pharmacology (including Human Exposure Limits Committee meetings) and to comment upon the Periodic Safety Update Report for the Product (PSUR).
7 Accountable for the development and validation of new Clinical Pharmacology enabling methodologies in close collaboration with internal and external experts for application in Proof of Principle and Proof of Concept studies, recognizing the need to start this process early in the Drug Discovery/Development process.


RESPONSIBILITIES:



1. To advise on, maintain, expand and optimize medical/scientific aspects in exploratory, clinical pharmacology and patient studies.
2. To contribute to the early and late phase Clinical Development Plans (CDP), Target Product Profile (TPP) Integrated Product Plan (IPP) and Global Product Plan (GPP).
3. To make recommendations on the inclusion of clinical pharmacology objectives in therapeutic studies and to make decisions on the focus and objectives of the Clinical Pharmacology sections of therapeutic studies.
4. To be the study-responsible physician in Clinical Pharmacology studies. To participate in the Product Study Working Teams (SWT), when applicable
5. To represent the Product internally and externally as a Clinical Pharmacology expert, including meetings with Regulatory authorities.
6. To contribute to and evaluate licensing opportunities from an Experimental Medicine aspect.
7. To contribute to Research Advisory Committees, Disease Advisory Teams and/or Therapeutic Area Strategy Teams as a representative of Clinical Pharmacology.
8. To write or review the Clinical Pharmacology section of the Investigators Brochure, Core Draft Sheet, the International Data Sheet and Summary of Product Characteristics documents.
9. To keep aware of the changing international Clinical Pharmacology regulatory guidelines for an early phase Clinical development program.
10. To safeguard ethical standards in Clinical Pharmacology studies.
11. To advise and supervise medical and scientific training in Experimental Medicine and to take part in internal and external educational activities.
12. To follow important developments and trends in the relevant scientific literature and at symposia/congresses.
13. To establish academic relationships within the (international) medical-scientific community, contribute to research in the relevant therapeutic areas, and to develop and retain contacts with opinion leaders within the field.


Responsibilities

EXPERIENCE7 MD with board certification/eligibility internal medicine or other clinical sub-speciality7 Fellowship training in clinical pharmacology desirable 7 2-5-years experience in early drug development (preferably obtained from a pharmaceutical company or contract research organization).7 Medical Advisers must be qualified to practice medicine, JOB SPECIFIC SKILLS7 Good oral and written communication skills with a demonstrated ability to write protocols, clinical trial reports and scientific peer-reviewed publications.7 Understanding of Good Clinical practice and knowledge of AstraZeneca SOPs relevant to the physician s role in Clinical Pharmacology 7 Good Presentation skills7 Familiar with research techniques7 Knowledge of opinion leaders in area of expertise7 Experience in establishing external collaborations.