Cambridge, Massachsetts, United States
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
The Head of Global BDPM is a member of the Global CD Leadership Team and is responsible for the strategic leadership and ongoing development of global capabilities in Biostatistics, Data Management, Programming and Medical Writing. The Head of Global BDPM should have functional expertise in at least one of these areas. Successful fulfillment of this role will significantly impact the Seqirus CD deliverables, ensuring on time performance of our clinical trial results and delivery of results and documents for use in critical regulatory filings. In addition, Head of BDPM must have doctoral level training to ensure adequate strategic and technical oversight for these essential functions. The Head of BDPM will have line management responsibility for permanent and contract/vendor technical data experts, statisticians and programmers (~20), and control of clinical study budgets (`$20 million).
Oversee efficient and high quality medical writing support of document writing and review to all CD functions and plan capacity ahead of time in line with projects requirements.
Ensure the Company is compliant with all relevant Disclosure requirements.
Establish and maintain a flexible external medical writing vendor relationship to meet the needs of the clinical programs.
Oversee provision and maintenance of key core biostatistical and analytic capability to support Company priorities, including but not limited to clinical programs, product risk management and clinical assay needs.
Ensure appropriate vendor support for non-core operational biostatistical activities.
Oversee clinical data management, clinical data standards, and medical coding so that reliable, high quality clinical trial data of a consistent standard are generated to support timely clinical program decisions and efficient generation of regulatory dossiers.
Oversee functional clinical and statistical programming to ensure timely and efficient assessment of clinical trial data during and upon completion of clinical studies that can support inclusion in regulatory dossiers.
Oversee development and maintenance of systems and processes to ensure compliance with all required regulatory and governance obligations.
Lead the conception and implementation of innovative solutions to drive continuous improvement.
Recruitment, retention and development of high quality staff and teams.
Provide strategic guidance and leadership to all functions within BDPM to ensure activities add value to and support clinical programs and Company strategy.
Responsible for aligning objectives across functions within the Department and to ensure optimal resource allocation to meet strategic objectives and project priorities.
Coordinate and facilitate the smooth engagement of BDPM staff and activities with other CD Departments and wider Seqirus.
Ensure accountable performance management of all staff against personal management plans and expected behavior.
A tertiary qualification in one of the 4 disciplines of this function is essential, preferably combined with relevant post-graduate qualifications.
A post-graduate qualification and research experience in a relevant areas are highly desirable.
Proven experience working in a clinical research environment is required. Vaccine development experience desirable.
Proven leadership is essential.Diplomacy and people management skills.
Comprehensive understanding of clinical research processes.
Attention to detail
Ability to work independently and as a team member
Written and oral communication skills
Proficiency in appropriate software
Time management – project planning and co-ordination/implementation.
Strategic thinking and analytical skills.
If you feel that your profile is in line with the role scope and you would like to apply for the opportunity, please send your CV to email@example.com