At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As the External Scientific Research Manager, in Gaithersburg, MD, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing practice and patients' lives.
AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through five key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, HER2 and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
In the role of External Scientific Research Manager, you will be responsible for the local management and co-ordination of Externally Sponsored Scientific Research Projects within a region, institution and/or therapeutic area. This role will interface with External Scientific Research Operations and external organizations (e.g. PI and/or Institutions) to ensure adherence to all relevant policies, processes and procedures.
Act as the primary local operational contact for local external organizations, ensuring that proposal guidelines and standards are met, escalating research proposals for review as appropriate
Support the review of External Scientific Research proposals to enable a consistent, high quality approach to evaluation
Ensure operational compliance with global and local policies, processes and procedures within a specific therapeutic area to ensure timely, cost efficient and high quality project delivery
Co-ordinate complex external research to ensure compliance with project management principles and internal process supporting external regulations to enable delivery of high quality research projects. This includes launch of new research trials.
Lead the project management of complex joint research projects ensuring compliance with project management guidelines, external regulations and internal processes to enable the delivery of high quality Investigator Initiated Sponsored Research and Externally Sponsored Collaborative Research (ESCR). This includes the initiation/maintenance of supplier contracts.
Revises all project planning in light of changing needs and requirements to ensure effective, efficient and compliant delivery of ESR.
Lead effective collaboration and communications between internal stakeholders and external partners to enable high quality research projects.
Manage projects to time, cost and quality, taking corrective action as required to ensure that project targets are met.
Contribute to ESRO metric/KPI reporting requirements to Oncology R&D, and TA leadership as required
Addresses as a matter of urgency any compliance issues, escalating problems as appropriate to the relevant ESRO member.
Supports the development of consistent project management processes across local ESR to enable a high quality project management approach
Ensure timely preparation of research CDAs/CSAs
Collaborate with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority
Prepare and maintain study budget in ESR web management system (ACCORD as necessary)
Ensure accurate payments related to the study are managed and comply with all local transparency requirements
Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements.
Maintain studies in ESR web management system, ensuring completeness of all essential documentation
Plan and lead activities associated with audits and regulatory inspections
Essential Requirements - Education and Experience
Bachelors degree within a scientific or healthcare field or significant and comparable experience
Project Management qualification or significant and comparable experience
Experience within the pharmaceutical industry ideally working within a clinical study/development field
Experience and knowledge of the clinical study and drug development processes and relevant guidelines, e.g. GCP/ICH for a specific therapeutic and geographical area
Other Skills and Capabilities
Effective relationship building and stakeholder management skills across functions, geographical boundaries and cultures
Creative and innovative approach to influence the development of more efficient and effective practices while operating with required policies and regulations
Flexibility and adaptability
High levels of enthusiasm and energy
High levels of organization
Oncology experience desirable
Next Steps - Apply Today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.