If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions -- join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development Scientist in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
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
Preparation of Key product Documentation- Assist in the creation of the protocol concept sheet (PCS) and the full protocol with support and input from other key team members such as the clinical development physician, Clinical Operations, Biostats, Translational, PK, and Regulatory. Assist in the creation and maintenance of the Clinical Development Plan (CDP) for assigned programs ensuring alignment with the Target Product Profile (TPP), taking into account operational feasibility, regional requirements, personalized healthcare (PHC) strategies and future payer considerations. Assist in the development of key documents to support the components of a regulatory submission (i.e. IND Annual reports, IB, Briefing book for pediatric implementation plan). Become familiar with the latest thinking regarding mechanism of disease, diagnostic tests, treatment, drug development trends, and regulatory requirements in assigned disease and therapeutic areas.
Data Review- Developing the key elements of data review plans (in collaboration with Data Management) for clinical studies and performing medical data review during study execution to ensure integrity of accruing study data including: eCRF development. Compliance of enrollment with Inclusion/exclusion criteria. Monitoring of end-point data (i.e. safety and clinical activity) recorded in eCRF. Review of physical Exam, Medical history and concomitant medication. Protocol Deviation review. Coding reviews. Table and Listing review under the supervision of the Medical Monitor, lead the collection and analysis of Serious Adverse Events including but not limited to: Lead the real-time collection and review of SAE information received from clinical sites. Interact with study sites to complete the medical data on the SAE. Prepare SAE narratives for inclusion in Clinical Study Reports and regulatory submissions. Assure the SAE assessment, including source data, is fully documented in the TMF. Facilitate the reconciliation of clinical and safety databases. Operational Support for Clinical Studies- Provision of Clinical Development input into the tactical execution of clinical protocols by working collaboratively with colleagues in relevant functions e.g. Clinical Operations/ Biostats etc. Activities are expected to include: Involvement in the selection of clinical research sites and service providers. Interacting with project managers and CRAs from CROs or AstraZeneca Global Monitor Network (MCCD). Working with third party vendors to ensure protocol end-points are collected appropriately e.g. spirometry, e-diary vendors. Participation in Investigator meetings and other scientific committees as required by the protocol (e.g. independent reviews, Data Safety Monitoring Boards, Steering Committees, etc.). Study risk mitigation and highlighting of potential issues and solutions. Training MedImmune/CRO/MCCD personnel and investigational sites to ensure protocol requirements are met. Establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems (eCRF), and final reports. Ensure study level activities are conducted to allow implementation of the study protocol in a manner consistent with the current plan/timeline and CDP. Review and interpret study results. Assist in preparing publication of study results.
Internal Collaboration- Assist in the linkage between Clinical Development and other functional groups within MedImmune: Establish strong links between company experts in relevant departments, including regulatory, bio-pharmaceutics, discovery, translational medicine, and pharmacology/toxicology sciences, to initiate and expedite clinical studies. Collaborate with translational medicine to optimize the approach to study target neutralization, understand mechanism of action and deploy Personalized Health Care (PHC) strategies. Coordinate with pharmacovigilance personnel in developing the Development Risk Management Plan in conjunction with MedImmune's Safety Monitoring Committee and other external groups as appropriate. Assist with the management of and input into Scientific Advisory Boards convened to develop CDP strategies as appropriate.
External Collaboration- Assist efforts to obtain external scientific and clinical validation of clinical research protocols by establishing links with outside experts to initiate and expedite clinical studies. This may include seeking advice from KOLs, regulatory, pricing/reimbursement, and market access experts.
- PhD, or Master's degree in heath science field, PharmD, MD, or other relevant advanced degree in a health science field.
- Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or haematology.
- Two or more years of experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment.
- Immuno-oncology development experience desirable; global pharmaceutical experience.
- 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.
- Ability to relate to colleagues and associates at all levels both inside and outside the organization.
- 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; experience managing and developing others (Director only).
- Able to act independently on most issues after getting initial guidance; will require supervision from MD's when it comes to patient safety issues and overall study conduct issues.
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.