AstraZeneca Pharmaceuticals LP Senior Director Global Publications, Oncology Business Unit (OBU) in Gaithersburg, Maryland
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 four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
The Senior Director Global Publications, Oncology Business Unit (OBU) has direct accountability and responsibility for the global leadership and line management of a team of Global Publication Leads (GPLs) across multiple sites encompassing the breadth of the AstraZeneca late-stage portfolio. The Sr Director Global Publications, OBU provides publications expertise and insight into the development and optimisation of integrated strategic global publication plans, driving scientifically rigorous and compliant publications across the product lifecycle. The role interfaces with the Global Head of Publications, VP OBU Medical, Clinical TA VPs, Medical Affairs Leaders (MALs), GPPS roles and the regions to ensure aligned global publications strategies and plans are developed and delivered in a globally consistent way, aligned to the integrated Medical Affairs Plans. The Senior Director manages the Global Publication Directors (GPD) to lead their teams in an aligned manner, assuring consistent delivery across the portfolio. In addition, the role ensures through a range of outsourcing partners, optimal value to drug projects, and leads the compliance monitoring activities required to uphold the highest external reputation.
· Development and delivery of the integrated Global and US Oncology publication strategy
· Lead the disease area teams of GPLs responsible for working within specific oncology disease areas or drug classes to align and build an integrated publication strategy and plans for global clinical studies from Phase I (in humans studies) and non clinical trial sources including HEOR, Epidemiology, RWE, Payer, and NIS so that the integrated publication strategy is consistently applied across all study designs, and clear and supportable scientific data are communicated to internal partners (product teams, governance bodies) and external customers (regulatory authorities, payers, physicians and patients)
· Directly manage GPDs and GPLs across all tumour types and drug classes
· Lead global performance management, recruitment, training, and coaching of the OBU Publications team.
· Lead skills development for the OBU Publication team through the GPDs to ensure delivery of training programs that are up to date with AZ publication policy and compliance requirements, as well as deliver innovative scientific, publication and ethical insight to AZ
· Direct the development and maintenance of GPL best practice and expertise, implementing best practice so that AstraZeneca maintains a leading edge in ethical publication standards and in the use of publications as a competitive advantage in drug development.
· Coach staff on principles of integrated strategic publication planning
· Drive the AZ strategy for compliance with internal and external publications policy and standards
· Drive training and development of educational programs for GPLs and Marketing Companies on AZ Publications Policy and procedures
· Provide leadership and influence any ongoing strategic development within GMA and other areas that may impact AZ’s ability to deliver industry-leading publications activities in an ethical way
· Build advocacy for publications through effective relationships with key stakeholders and customers across all relevant SET areas, and by creating the framework to maximise brand value through industry-leading publications activities
· Influence any ongoing strategic development within GMD, GMA and other areas that may impact AZ’s ability to deliver industry-leading publications activities in an ethical way
· Provide visible leadership support to GPLs working in alliances and with joint venture partners and to key alliance partners, ensuring the right scientific and technical skills and capabilities from Publications and driving effective behaviours lead alliance relationships to support the success of strategic alliances Assesses and optimizes resource utilization working with Global Product Directors, Development Brand Leaders, Medical Evidence Directors, TA VPs and MALs
· Lead publication training and awareness across AZ to raise the profile of, strategic publications planning, and publications compliance/delivery
· Keep up to date with any internal or external developments (e.g. new regulatory and publication guidelines worldwide) that potentially impact on Publications; disseminate information and develop strategies for meeting new requirements
· Collaborate effectively with MALs to support other Medical Affairs, OBU functions
· Participate in leadership teams in both within and out of the OBU and serve as an advocate for the team. Able to synthesize data from across the team
· Represent AZ in relevant professional bodies and conferences as an advocate for compliance and publication practice
Minimum Requirements –Education and Experience
Functional & Business knowledge
Experience, Functional Knowledge, Education, Specialist Skills
· PhD or advanced post-graduate scientific degree with relevant proven experience in pharmaceutical/medical communication/healthcare industry, development, research
· Demonstrated experience as a medical publications professional and in depth knowledge of the principles of developing effective publication strategies and plans (preferred)
· Demonstrated performance, budget and resource management skills in a global organization
· Broad knowledge of the drug development process, with a focus on integrated strategic publication planning (preferred)
· Broad knowledge of relevant disease areas
· Demonstrated line management skills
· Executive presence to engage senior leadership across the business
Skills and Capabilities
· Global Team experience with demonstrated ability to work in a cross cultural business environment
· Proven ability to set and manage priorities, resources, performance targets and project initiatives in a global section and project environment
· Proven management and coaching skills, driving performance and long-term development of others in order to accomplish individual, team and organisational objectives
· Proven flexibility and adaptability to changing regulatory and publication environment by developing solutions that impact beyond the function
· Manages change with a positive approach to the challenges of change for self, team and the business.
· Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
· High ethical standards
· Flexibility / Adaptability
· Conceptual / strategic thinking
· Concern for people
Internal and External Contacts/Customers
· SET Sponsors of the AZ Publication Policy and Chief Medical Officer
· Global Head of Medical Capabilities, Head of Global Publications, OBU Franchise VPs, R&D, GPPS roles and other regional Group Managers of Publications
· Global Section Heads in GMD (e.g., Biostatistics, HEOR, etc)
· iMED Clinical VP and Late Development Directors in the Clinical TA organisation (concerning MSD, Study/Brand Physicians, CPD roles and responsibilities in publications activities)
· Medical Affairs Leads (MALs)
· Members of Clinical Project Teams and associate members, e.g. GPS, HEOR Scientists
· MEDICAL Evidence Directors
· Global Product Directors – as signatories of each product’s publication strategy and plans
· Marketing Company Medical Directors – to ensure local publications comply with publication standards
· Intellectual Property and Legal Advisors
· Group Internal Audit
· Cross functional compliance network from Legal, Global Compliance Group, contacts in Promotional Regulatory, Medical Affairs or Scientific Affairs
· US compliance group particularly in respect of CIA requirements
External Principal Investigators and Key Opinion Leaders when directly involved in projects
International Society of Medical Publications Professionals (ISMPP) or other professional societies (TIPPA, CBI, CSE, etc)
Journal Editors (e.g., BMJ, Lancet, etc)
Medical communications agencies
· Reports to the Head of Global Medical Capabilities, OBU
· Direct reports: GPDs and GPLs in UK/US
· Indirect reports: GPLs in UK/US, Publications Specialists in UK/US
Accountable for Medical affairs budget for publications and local budget (i.e., salaries, training, travel, IS support, discipline/strategy development).
Measure of success
· Positive feedback and endorsement from TA VPs, regional and GPPS leadership (GPPS VPs, RVPs and RMDs) publication plans, staff performance, publication compliance, metrics and tools developed, as well as recognized for value adding challenge, support and thought leadership
· Strong external relationships established and positive feedback from international KEEs and publication societies
· Positive feedback on effective and valued GPL deployment from internal stakeholders
Next Steps -- Apply today!
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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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.