Clinical & Medical Affairs Director —
North Italy
Location: Vercelli, Italy
Salary: Competitive + benefits
Closing date: 31/10/09
Job posted: 1 Oct 2009
Job description
Based close to Vercelli, Italy, reporting to the Vice President,
Clinical & Medical Affairs. Responsible for managing the Clinical Team
in charge of clinical projects in the region. Responsible for
supervising all activities related to clinical studies in accordance
with the applicable government regulations, GCP, Investigational Plans
(IP), and Standard Operating Procedures.
Responsible for accurate planning and successful implementation of
all Pre Market clinical studies (aimed at getting CE Marking and FDA
approval), Post Market clinical projects and scientific communication.
Direct reports
- Manager, Clinical Shared Services (this manager is supervising
the Clinical Shared Services Team. See details below)
- Senior CRA working on a strategic project
- Field Clinical Manager
- Post Market Clinical Manager, in charge of clinical studies and
activities with marketed products.
Main responsibilities of the Clinical Shared Service Team (5 persons
total):
- Management of each study (including study design, protocol
development, data analysis, report preparation);
- Coordination and management of clinical support resources such
as Clinical;
- Research Associates (three CRAs at present), one
Biostatistician, Contract;
- Research Organizations and Consultants;
- Scientific communication;
- Support to the key functions at Sorin Group (i.e. Research &
Development, Regulatory Affairs & Quality Assurance and Marketing)
and to the Sales Organization as required.
Essential functions
- Contribute to Global Teambuilding in order to achieve synergy
with the North American Team;
- Participate in defining the global clinical strategy for each
product. Identify the investigational sites in Europe and ROW;
- Establish and maintain contacts with Opinion Leaders,
Investigators and site personnel;
- Build an effective collaboration with the Marketing Team and
Sales Organization;
- Supervise all activities needed to properly conduct multiple
projects within project timelines and study budgets;
- Ensure sponsor and site compliance to national and international
regulations;
- Participate in Audits activities as necessary;
- Assist with preparation of Regulatory Bodies applications,
amendments, supplements, reports, and presentations needed to
conduct studies and approve products;
- Represent the department in product development and project
meetings as required;
- Assist with establishing and/or modifying department procedures
and systems;
- Put in place specific training programs for the clinical team
- Actively contribute to department budget preparations and
reviews;
- Travel as necessary to clinical centers and major events in
order to establish and strengthen the clinical partnership.
Qualifications
Minimum Bachelor’s degree in health sciences or related field.
Ideally candidates should hold an MD.
Experience
- Minimum 8 years experience in the clinical study field and/or
cardiovascular field.
- Expertise in heart valves and Cardiac Surgery products
preferred.
Knowledge, skills and abilities
- Results orientation and ability to work under pressure;
- Leadership skills and change management;
- Ability to build long term relationship and clinical partnership
with KOLs;
- Communication and presentation skills. Knowledge of medical
device regulations and clinical study design and implementation;
- Knowledge in the field of cardiac surgery and heart valves;
- Stress and conflicts management.
Travel time estimated at 30%.
For a confidential discussion about this position please do not
hesitate to contact me by forwarding your CV to
dhall@barringtonjames.com
or by telephone on +44 (0)1293 776644.