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Vacancy details
Vacancy description:
Job Code:
AQ1729 - Head of Clinical Research
Job Title:
Head of Clinical Research
Job Category:
CRM (Clinical Research Management)
Contract:
Permanent
Discipline:
Any Discipline
Country:
Switzerland
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
07 Sep 2008
Head of Clinical Research
The Organisation
Philip Morris International, based in Lausanne, Switzerland, is one of the largest tobacco companies in the world. We currently hold a 15% share of the international cigarette market and employ more than 70,000 people worldwide. Our brands are made in more than 50 factories around the world and sold in over 160 countries.
With its employees representing over 100 nationalities and 80 languages, PMI’s diverse web of people are linked by a singular commitment to excellence.
The company believes in hiring, training and promoting the best global talent in all its business functions.
PMI provides ongoing training to employees throughout the organisation, as well as an opportunity for many employees to work outside their home markets and thereby gain the sort of global experience the company seeks.
Along with its portfolio of leading brands, the company’s employees are its most critical and valued assets.
PMI is committed to selling and marketing its products in a responsible way. This includes:
Being open about the health effects of smoking and working to address society’s concerns about its products
Supporting strong and effective tobacco regulation for both its products and the industry
Supporting worldwide minimum wage laws and backing youth smoking prevention programs across the globe
Maintaining high standards of safety wherever the company operates
Continuing to take environmental measures on waste, recycling and the protection of resources around the world
PMI’s values guide its day-to-day operations. Its goals for doing business and interacting with society, both locally and globally are:
Listening to society’s concerns about its products
Seeking common ground with its critics and implementing real solutions
Acknowledging and embracing its role as a responsible citizen and an active member of the community
Being open and transparent with its stakeholders and society as a whole
Acting with integrity, respect, trust and a collaborative spirit
The company maintains high standards of safety wherever it operates, continually monitoring its production practices in its factories around the world to identify and share possible improvements.
The company supports strong and effective regulation for its products and its industry, and is committed to working with governments and the public health community to achieve that goal.
Context Of The Role
In pursuit of the goal to deliver next generation harm reduced products the Product Risk Management (PRM) group is building the ability to effectively measure risk associated with these products in comparison to conventional cigarettes. A complete, effective risk assessment for these products will necessitate the development of both non-clinical and clinical methods specifically tailored to measurement of risks most commonly associated with tobacco use.
There is little or no precedent for integrated tobacco product risk assessment and the PRM group is developing new methods through effective leverage of the considerable knowledge available from the epidemiology of smoking, along with extensive mechanistic research into the prime smoking-related diseases. This is coordinated through state-of-the art mathematical risk modeling, which enables both the identification of effective measurement endpoints, and facilitates appropriate interpretation of data from both clinical and non-clinical studies.
The Clinical Research group is a new organization within PMI R&D. Established just four years ago, the group is currently defining the strategy, structure and organisation of the department and is establishing the necessary infrastructure to run studies to GCP equivalent standards. Comprising twelve individuals, the group is divided into two teams: a clinical pharmacology team responsible for study design, methodology and protocol development and an operational team incorporating data management, statistics and experienced clinical research professionals who are managing outsourced clinical trials. Trials are ongoing in various geographies including those aligned to potential launch of new products.
Although clinical testing of tobacco products can be based on experience from other settings, there are some very specific challenges presented by the nature of these products. Considerations such as the extent of clinical support required for support of new products, the methodologies needed, and the requirements for shortened risk assessment cycles imply that the size and make-up of a clinical assessment group in PMI R&D will be different from those found in more traditional industries associated with clinical testing. This provides specific, unique challenges and also represents a huge opportunity for application of innovative approaches.
The Role
Having identified the need for support in developing the clinical research infrastructure within PMI R&D and defining standards, processes and methodologies for assessment of the new generation products, PMI R&D is now seeking a Head of Clinical Research. The primary role of the Head of Clinical Research will be to develop a long term strategy for approaches to clinical research, adapting and anticipating best practices and seeking new and innovative approaches for clinical assessment of next generation, potentially reduced harm tobacco products. In accordance with the agreed strategic approach the role also includes providing direction for the efficient execution of clinical studies to satisfy the company’s requirements for product assessment and research. PMI R&D is seeking an individual who can build a strategic approach to clinical assessment of next generation tobacco products in the context of the overall integrated risk assessment programme being developed in the PRM group.
Primary Requirements
Develop a strategic point of view for the future evolution of clinical studies given existing and emerging business factors and constraints.
Define appropriate organizational structures, standards and processes for execution of clinical studies for PMI
Contribute to the development strategy of products and develop and define the clinical assessment plan
Guide the execution of clinical studies for the identification of new biomarkers and methodology as identified from fundamental research and other sources
Drive progress of clinical activity in product and research programs
Recommend / implement measures of efficacy for running clinical assessment programmes (e.g. Cost effectiveness; reliability of data; contribution to measurement certainty of risk assessment; reproducibility; minimisation of duration of studies)
To manage, motivate and appraise all direct reports ensuring succession planning strategies are in place and ensuring effective team management at all times
To be responsible for performance management within the team including establishment of development needs and any corrective actions
Evaluate best practices in other sectors and adapt to PMI needs
Experience
Around 10 years of experience within a pharmaceutical, medical devices, biotechnology company or a Clinical Research Organisation with at least 2-3 years leadership of multi-centre international studies
Knowledge of current regulatory requirements and guidelines governing clinical research including ICH/GCP guidelines
Understanding and awareness of innovative clinical trial approaches in other industrial sectors
Proven line management and leadership ability
Proven track record of working effectively within complex project structures and multidisciplinary multicultural teams
Experience in management of multi-centre studies in Asia and Japan is desirable but not essential
Multi-therapeutic area expertise is desirable but not essential
Skills
Ability to operate as a visionary leader that is not constrained by past experiences but has the ability to think strategically and to communicate effectively at executive management level
Ability to take research ideas from others and develop executable clinical study plans
Ability to participate actively in cross-functional teams, bringing own expertise to these teams and applying the expertise of others to design and manage the performance of clinical studies against key metrics
Personal presence, leadership and drive to get the best from others
Willingness to take a ‘hands-on’ role as required
Package
Competitive base salary
Bonus 20%
Company car
Stock Options
Private Health Insurance
Holiday Entitlement
The package is negotiable, based upon the level of experience of the individual.
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