Senior Medical Affairs Leader - Gaithersburg, MD | Biospace
Get Our FREE Industry eNewsletter

Senior Medical Affairs Leader

AstraZeneca Pharmaceuticals LP

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
United States
Job reference: R-011829

Posted date: Aug. 02, 2017

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 a Senior Medical Affairs Leader in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

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.

Global Medical Affairs (GMA) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies and supports our internal stakeholders with medical insight and expertise. GMA provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. GMA aims to lead AZ in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

Main Duties and Responsibilities

  • Designs and manages the implementation of the GMA brand strategy globally and regionally
  • Designs and delivers clinical trials within Therapeutic Area of expertise, including clinical trial protocol oversight and study physician responsibilities
  • Closely follows medical developments within Therapeutic area and disseminates new information to transform clinical trends and emerging data into new plans
  • Liaises with the internal and external medical community
  • Delivers medical advocacy plan that drives successful launch of innovative and differentiated new medicines within the TA
  • Builds TPP based on medical knowledge, insights and internal/competitor clinical data
  • Supports team leader at TA Global Product Team, Global Brand Team and Global Medical Team
  • Accountable for engaging and cultivating relationships with leading global KEEs to gain: contribution/ participation in advisory boards, greater understanding of the therapeutic area and insights into unmet patient needs
  • Represents AZ at scientific and medical forums, including medical education forums, scientific roundtables, congresses, and symposia
  • Responsible for the co-ordination of Medical Affairs activities including:
  • Science Advisory boards
  • Ensuring the alignment of the publication and medical evidence plans to the Medical Strategy and Medical plan
  • Responsible for leading the initial development and ensuring the accuracy of medical promotional materials and communications prior to submission to GMQA (Global Medical Quality Assurance) for the final approval.

Essential Requirements

  • MD with specialist training in either Pulmonary Medicine or Allergy/Immunology or internal medicine with respiratory clinical development experience
  • Minimum of 5 and ideally more than 8 years in Industry, with experience in leading clinical trials to support approval (Phase 2-4) (i.e. experienced clinical trial specialist strongly preferred).
  • Experience in leading a clinical study program to support an indication, including overall design, clinical development plan and TPP
  • Experience in writing clinical aspects of briefing documents for regulatory interactions and played a critical role in writing submission dossiers
  • Previous experience of leading cross-functional study delivery teams
  • General understanding of statistics, safety, regulatory requirements.
  • Demonstrated experience with developing Global or local medical strategies
  • Strong network of external experts in Respiratory medicine
  • Experienced clinical trial specialist (essential) with Medical Affairs knowledge (strongly preferred)
  • Patient-centred but commercially aware, values-driven approach
  • Level 3/ 4 leadership capabilities
  • Proven ability to engage, influence and build effective relationships with KEEs
  • Strong verbal and written communication skills in English
  • Strong project management skills and experience of managing priority brands
  • Broad understanding of more than one part of the business i.e. Discovery, Clinical, Regulatory, Medical or Commercial roles
  • Presentation and influencing/negotiation skills
  • High ethical standards required

Desirable Requirements

  • In order to accomplish our goals and enable the best patient outcomes, we look for AZ medical network leaders to have five (5) core capabilities and act as role models to our AZ values. These capabilities include:
  • Experience in leading a clinical program to support an indication or promotional claim or scientific exchange including overall design, clinical development plan and TPP.
  • Track record of building and maintaining a deep and continued connection to Medical Practice/healthcare delivery
  • Collaborative/matrix management skills with a focus on leading diverse groups (e.g., cultural, geographical, functional) to achieve excellent results in shared goals
  • Well-developed communication and influencing skills with the ability to distil complexity down to what matters to our stakeholders
  • Strong financial/budget and project management skills
  • Business acumen.

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.


Please See Description