• Development manager

Drug Development – Project Manager

December 2011

Position Description for Project Management

ENAKM is seeking a talented candidate with experience in drug development to help manage the development of our EU funded pre-clinical candidate through to a proof-of-concept clinical study, including pre-clinical, clinical and regulatory interaction. The candidate will manage the external project partners within the syndicate and is responsible for the successful conduct and completion of the project within budget and on timeline and for ensuring the quality of the project according to ENKAM SOPs, guidelines and requirements.

• Job location - Denmark, UK or other European locations
• Language requirements - Excellent spoken and written English

Key tasks for Project Management

• Maintaining close communications and collaborating with sub-contractors and team members to ensure that projects remain on schedule and within budget, are appropriately resourced, and meet quality standards according to SOP and/or other Regulatory requirements/guidelines
• Setting-up and refining internal SOP and data collection structure
• Preparing and implementing Project and Communication Plans.
• Reviewing documents to ensure completeness and high quality standards
• Working with team members and sub-contractors to help resolve any project issues in a timely and effective manner
• Delivering presentations at internal and external meetings
• Identifying and proposing modification to the study if necessary and defining project requirements, deliverables, and schedules
• Identifying out-of-scope tasks and assisting with writing appropriate documentation.
• Facilitating team meetings and assuring follow-up of action items.
• Proactively identifying issues and developing strategies for assuring study timelines are met and assuring quality deliverables.
• Overseeing the preparation and distribution of materials for project and meetings including minutes and agendas.
• Managing project start-up to close out activities, and overseeing distribution of project documents.
• Managing the preparation and maintenance of central and site files for projects
• Assisting in business development meetings and the preparation of proposals

Optional tasks:

• Maintains knowledge of current regional / national regulations and provides leadership to the teams to ensure submissions are in accordance with specifications and/or standard industry practice.
• Defines high quality processes, updates and preparation of documentation for regulatory interaction and due diligence.

Desired Skills & Experience

Qualifications

• 7+ years of relevant pharmaceutical industry experience, MBA or graduate science degree a plus
• Drug Development project management experience required. Experience managing projects across discovery, preclinical and clinical stages preferred
• Operational experience and familiarity with the drug development process, including both internal functions/activities and external regulatory requirements
• Analytical and organizational skills (resources, timelines, cost/risk/benefit analysis)
• Knowledge of project management tools (MS Project or equivalent, GANTTs, Excel, etc.)
• Proficiency working with document management and publishing software, a plus
• Excellent organizational skills, including the abilities to prioritize workload, work independently, and meet deadlines.
• Detail-oriented
• Effective written and oral communication skills in English
• Good Communication skills (presentations, writing, slides, etc)
• Understanding of science sufficient to draw implications, assess risks and recommend action plans
• Able to handle complexity and ambiguity as well as be able to prioritize effectively
• Highly collaborative
• Strong problem solving skills and strategic planning for global submissions
• Proven skills in managing and integrating groups of diverse disciplines in collaborative activities; possessing the ability to influence without formal authority
• The ability to work independently and with minimal supervision

For more information please contact Morten Albrechtsen at ma @ enkam.com