JOB OPPORTUNITY
INTERNATIONAL MEDICAL DIRECTOR
BRIEF COMPANY PROFILE
Our client is a global, research-driven pharmaceutical company focusing on the development of prescription-only-medicines, and they are a global market-leader within their therapeutic area. The company headquarter is in Greater Copenhagen, Denmark with subsidiaries, production facilities and distributors worldwide.
THE POSITION
Our client is looking to bring onboard a high-caliber International Medical Director to join the Global R&D, Medical Sciences team. The role will take on medical responsibility within clinical projects – hereunder planning and management of Clinical Development Program(s). The International Medical Director has substantial influence on the tasks and the results of drug development within the organization, affiliates and among external collaborators and can expect to gain support for appropriate publication and other career advancement initiatives.
POSITION PROFILE
Position title:
International Medical Director
Reporting line:
Chief Medical Officer
Location:
Greater Copenhagen
Traveling:
20-30 days per year
Responsibilities & Tasks:
RESPONSIBILITIES:
Key responsibilities
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Medical responsibility within projects.
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Planning and management of Clinical Development Program(s).
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Planning and managing, execution, data processing and data reporting in clinical trials.
Geographic responsibility
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Clinical drug development worldwide in alignment with Global Clinical Development organization.
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Collaboration with internal and external stakeholders within our client's global organization and countries all over the globe.
TASKS CONTRIBUTING TO:
Tasks within Planning and Management of Clinical Development Program(s)
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Clinical Development Strategy.
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Medical input to clinical development program(s) for phases 1-4.
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Medical and clinical expertise to the generation of the Product Development Plan (PDP) and Strategic Product Plan (SPP).
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Presentation of clinical program strategy at meetings with regulatory authorities, first submission.
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Ensure content and quality of the Clinical Part of the Submission Dossier, first submission.
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Generation of high-level clinical documents for submission of new drug applications worldwide.
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Development of Medical and Clinical Pharmacology summaries for interactions with health authorities.
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Establishment and chairmanship of internal scientific boards.
TASKS RESPONSIBLE FOR:
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Presentation of clinical development program strategy at meetings with regulatory authorities (except first submission)/advisory board meetings / PMCom and DPCom and DRB/BRB.
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Medical deliverables to the Pediatric Investigation Plan (PIP) for a drug candidate.
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Ensure content and quality of the Clinical Part of the Submission Dossier, except first submission.
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Clinical/medical input to Risk Management Plans.
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Medical input to relevant risk-assessment plans.
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Presentation of medical aspects of the clinical development program at internal and external meetings such as meetings with health authorities, congresses, investigator meetings.
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Cross project medical coordination towards the Line Manager/Vice President.
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Provide medical expertise in a therapeutic area with focus on given project related trials to establish substantial evidence for safety and efficacy in the clinical development program(s).
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Post-submission activities (first submission) in order to achieve regulatory approval and optimal labelling to allow successful launch of the drug.
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Post-submission activities (except first submission) in order to achieve regulatory approval and optimal labelling to allow successful launch of the drug.
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Establishment and maintenance of an external support network including investigators, key opinion leaders and/or outstanding research scientists.
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Participation in Project core group and/or Global Project Team (GPT).
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Member of Medical and Sciences Team.
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Development of treatment algorithms.
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Act as internal and external spokesperson for medical aspects of a given project.
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Establishment of external advisory boards in cooperation with internal stakeholders.
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Participation in safety committees.
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Input and advise within the company based on updated knowledge of the scientific medical literature regarding a given key project / development project / scientific area.
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Internal and external lectures in given therapeutic area.
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Medical input to Investigator’s Brochure and subsequent updates.
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Maintenance of own medical competencies during the execution of the clinical development program(s) for a given project.
Tasks within Planning and Managing in Clinical Trials
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Project responsibility and day-to-day coordination of medical staff within a given project.
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Medical responsibility during the execution of assigned trials described in the clinical development program(s) as defined by the specific key deliverables.
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Trial Outline development and approval.
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Ensure needed medical deliverables and content of individual protocols and Case Report Forms.
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Production issue management support including medical input to Q/As via Medical and Sciences Team.
Tasks within Execution in Clinical Trials
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Provide medical competencies during the execution of the clinical development program(s) specific clinical trials to trial staff.
Tasks within Data Processing in Clinical Trials
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Medical queries during trial execution and data cleaning.
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Clinical laboratory surveillance.
Tasks within Data Reporting in Clinical Trials
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Medical content of Clinical Trial Reports and publication.
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Medical, therapeutic and trial knowledge to publication of data.
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Scientific support to Congresses, exhibitions, medical lounges and symposia.
Key success criteria:
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Successful provision of medical input and guidance to clinical development program(s) for phases 1-4.
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Successful establishment, participation and/or chairing of internal scientific boards and external advisory boards.
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Ensuring that questions or queries from health care professionals or regulatory authorities are appropriately answered and that relevant documents are submitted.
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Successful establishment and maintenance of external support network including investigators, key opinion leaders and outstanding research scientists.
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Successful provision of scientific support to congresses, exhibitions and symposia.
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Successful collaboration and interaction with internal and external stakeholders.
CANDIDATE PROFILE
Educational background:
Preferable MD or M.Sc. in Human Biology or like.
Language:
English – fluent (verbally and written).
Ideal experience and competencies:
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Preferably more than 5 years of experience within the following field of expertise:
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Physician and/or relevant specialist education.
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Principal Investigator/Co-Investigator from a clinical setting and/or pharmaceutical industry experience from a clinical development role
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Preferably experience with the strategic and planning aspects of clinical trials and clinical development within or in relation to the pharmaceutical industry.
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Preferably good international network with good access to key opinion leaders.
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Preferably experience from working in a project oriented, international matrix organization.
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Knowledge of the pharmaceutical business.
Personal competencies:
Communication
Possesses excellent oral and written communication skills in English. Communicates the central issues in a discussion in a clear, fluent and precise manner, while being able to keep the recipients' attention. Produces written material, which is clear, fluent, precise and easy to understand for the recipients. Attentive to the needs of others when he/she speaks.
Flexible/Adaptive
Ability and willingness to quickly adjust to new situations in a continuously developing environment. Navigates smoothly when faced with late/last-minute changes in customer demands, requirements etc. Finds a way forward, reallocates resources, sets new priorities, and ensures alignment across the organization.
Team orientation
Is a flexible, empathetic, tolerant and service-minded team player. Sees opportunities rather than limitations. Collaborates, shares information, supports and works well with others with a view to obtain team objectives.
Intercultural understanding
Able to communicate with people from other cultures, notices and relates to problems as seen from other cultures' perspective.
Take control/action-oriented
Makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through.
Self-aware
Inspires confidence and makes a good first impression, appears well-balanced, honest and sincere, appears trustworthy and competent, gains other people's trust.
Initiative
Is proactive and able to inspire others and is able to take own initiatives without hesitation. Actively seeks influence and starts up actions on own initiative.
For further information:
Please contact Sebastian Brabrand, Research Associate, Albright Life Sciences A/S at:
M: +45 2233 2927