Assoc Director/Director Early Clinical Development Oncology

AstraZeneca   •  

Gaithersburg, MD

Industry: Pharmaceuticals & Biotech

  •  

Not Specified years

Posted 28 days ago

We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Main Duties and Responsibilities

This is a unique opportunity to join MedImmune at a time of tremendous growth and acceleration in the oncology biologics portfolio. This is a fast-paced and dynamic work environment where, with increasing levels of responsibility, you will be responsible for medical monitoring of ongoing clinical trials, the planning and conduct of clinical trials, providing long-range clinical development planning, planning and managing of clinical research projects and clinical development programs in oncology, collaborating with and providing clinical input and expertise to pre-clinical and translational sciences, and setting and achieving goals and meeting timelines in accordance with corporate goals and budgets. You will serve as the project Medical Monitor while working in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development. You will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.

You will be a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel immuno-oncology therapies for cancer patients, and have the opportunity for growth and development while working in a vibrant environment and "biotech" culture. Additionally, you will have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.

Specific duties and major responsibilities include the following: Serve as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance; Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports; Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical oncology; Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products; Provide leadership on cross-functional product development team(s) as experience allows; Participate in identification, selection and conduct of negotiations with clinical research centers and investigators; Participate in the selection and management activities of CROs; Supervise project team members in planning, conducting and evaluating clinical trials; Oversee planning and management of investigator meetings, advisory boards and other scientific committees.

NOTE: This position can be located in either the US (Gaithersburg, MD) or UK (Granta Park, Cambridge)

Essential Requirements

Education:

  • MD with current medical license
  • Board Certification in Oncology or Hematology (OR board eligible in medical oncology)

For Associate Director level:

  • At least 1-2 years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical or CRO environment

For Director level:

  • At least 2-5 years of experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment.

Desirable Requirements

  • Immuno-oncology early clinical development experience
  • Experience in molecular oncology and/or translational science
  • Excellent oral and written skills, strong interpersonal and listening skills
  • Results driven to achieve creative and sound outcomes
  • Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
  • Ability to make sound and timely decisions; agile in learning and action oriented
  • High level of emotional intelligence; able to deal with ambiguity
  • Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams