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Director, Medical Communications, Late Phase Oncology

Location Gaithersburg, Maryland, United States Cambridge, England, United Kingdom Job ID R-066753 Date posted 11/26/2019

Director, Medical Communications, Late Phase Oncology

At AstraZeneca, we're proud to have an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express varied perspectives - and are made to feel valued, energised and rewarded for their ideas and creativity. We're working on developing new medicines that will improve the lives of patients worldwide, would you like to join us?

The global Medical Communication Science (MCS) group provides communications and medical writing leadership across all phases of clinical development and across worldwide clinical submissions and approvals. We ensure that IND/NDA/BLA/MAA/JNDA/CN/ROW clinical documents align with project strategies, meet regulatory requirements and adopt the best communications practices. Our clear vision is to authoritatively drive strategic communications excellence to achieve successful submissions and approvals, ultimately playing a key part in us achieving our goal of delivering medicines to patients most in need and as swiftly as we can.

Role

As Medical Communications, Therapy Area Head – Oncology you will lead a team of Medical Communications Scientists (MCSs) to provide strategic communications leadership in delivering global clinical regulatory submissions across the Late Oncology portfolio to achieve first-cycle approvals. You will be responsible for provision of internal and external resourcing strategies to ensure business goals are met, which will entail maintaining relationships with multiple stakeholders including external vendors. As a valued member of the global Medical Communications Leadership Team you'll also lead the Oncology Late MCS group, including line management of a team of writers.

Responsibilities

  • Lead the implementation of Strategic Clinical Communications and drive input to the global clinical development strategy (from influencing study design, and from TPP to Label) from a communications perspective
  • Provide strong support for TA projects bringing strategic communications advice, influencing the development of communications to global business, global clinical development, and to health authorities
  • Provide thought leadership which inspires others to always adopt the best writing practices
  • Lead and develop a team of direct reports, influencing their development, planning resource capacity and growing your team when needed.
  • External vendor management to support delivery to portfolio
  • Collaborate within own area on managerial accountabilities to ensure alignment and global consistency

Requirements

To succeed in this exciting role, you will be recognized externally as an inspiring leader and expert within Medical Writing, with significant confirmed experience managing, leading and developing teams in this area. Your validated management and mentoring skills will be evidenced by your track record of driving performance within your teams to accomplish goals.

As an excellent communicator, you will comfortably influence, negotiate and manage stakeholders with ease.

Essential

  • Bachelor’s degree in relevant scientific discipline
  • Experience gained within the pharmaceutical/biotech industry with a comprehensive knowledge of the clinical drug development process, with experience of the TAs related to AstraZeneca’s products
  • Significant experience authoring clinical regulatory submission and leading writing activities for NDA/MAA submissions, including experience of Regulatory interactions to support or defend the commercial label or drug approvals
  • Proven ability to advise and lead complex medical communications projects
  • Excellent people management, mentoring and coaching skills
  • Ability to work with vendors to deliver to budget, quality, time and cost
  • Willingness to undertake domestic and international travel

Desirable

  • MSc or PhD in relevant scientific discipline
  • Authoritative reputation within the business and industry
  • Extensive knowledge of the latest technical and regulatory expectations

This is a permanent opportunity which will be office based in either Cambridge UK, or Gaithersburg US.

Competitive salary and benefits apply.

Posting date: 26th November 2019    

Closing date: 4th January 2020



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.