Medical Director Translational Medicine

Medical Director Translational medicine

The Medical Director of Translational Medicine will play a critical role in bridging the gap between preclinical research and clinical application. This position involves leading efforts to develop and implement strategies that ensure the effective transition of therapies from the lab to clinical trials. This individual will lead translational aspects of clinical studies, collaborating with cross-functional teams to support translational and experimental medicine.  The role will focus on rare diseases across the therapeutic areas of interest for Alexion.  The ideal candidate will have a strong background in translational medicine, with a focus on rare diseases.

Responsibilities

• Create and execute plans translational science and experimental medicine
• Develop, in collaboration with other members of the cross functional team clinical and scientific aspects of translational studies from preclinical through Proof-of-Concept studies supporting:
  • Human target validation
  • Candidate indication selection
  • Preliminary clinical plan development
• Collaborate with early clinical development leaders within the DRS organization to support the transition from Research to the DRS organization in preparation for IND
• Support the design of early clinical trials through Proof-of-Concept, including experimental medicine studies
• Partner with translational science team to drive connectivity between the research and DRS organizations
• Design and execute translational plans, to support clinical development programs.
• Develop and implement patient enrichment strategies to support the core aspects of the program
• Serve as a scientific and medical expert in translational medicine, providing guidance and insights to internal teams and external partners.
• Collaborate with cross-functional teams during the design, execution, and reporting of early-stage clinical trials to ensure that biomarker and other translational data is available at the time of clinical trial result readout.
• Lead or participate in cross-functional working groups and engage in external interactions with academic institutions and scientific experts
• Prepare and review study protocols, clinical study reports, and translational medicine sections of plans, abstracts, and technical reports
• Present results and updates of projects at department, project, corporate, and scientific meetings
• Stay updated on the latest advancements in translational medicine and rare disease research, incorporating new knowledge into ongoing projects.

Qualifications

• A medical degree (MD) or Advanced Degree in Life Sciences is required
• Minimum of 3 years in translational medicine or translational research in an industry setting
• In-depth knowledge in a core specialty area with broad understanding of the wider scope translational medicine diseases is strongly preferred
• Proven competence in clinical therapeutics, drug development, and strategic resource management
• Thorough understanding of FDA and ethical guidelines relevant to the pharmaceutical industry
• Excellent communication skills and ability to interact professionally with individuals at all levels of experience and across worldwide cultures
• Conscientious, enthusiastic team player with excellent collaboration and teamwork abilities
• Strong analytical and evaluative skills
• Proficiency in MS Office and ability to interface effectively with technical platforms for medical information

Typical Accountabilities:
• Designs or manages the implementation of the Physicians strategy within Clinical Development both regionally and globally

• Uses expertise and knowledge of global issues to develop strategic Physicians objectives for inclusion into AstraZeneca’s annual business objectives

• Defines strategies or leads AstraZeneca’s response to complex technical issues for specific medical aspects in relation to current projects, new projects and various plans

• Provides expert advice in the area of specialism, influencing the development of statistics to the global business and Global Clinical Development

• Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans

• Liaises with the internal and external medical community to follow developments within areas of expertise

• Ensures an adequate number of qualified physicians is available for clinical testing to satisfy AstraZeneca’s objectives in the clinical testing area

• Maintains a high degree of understanding and awareness on new and emerging medical development

• Contributes to or manages the development of the senior management team in area of expertise

• Follows important developments and trends in scientific literature and develops contacts with opinion leaders

• Leads regulatory communication and preparation of higher level documents


Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - 30-50
• Manager of a team

What is the global remit? (how many countries will the role operate in?):
• 2 or 3 countries at a minimum of 40% of time

Education, Qualifications, Skills and Experience:
• Essential: Bachelor's degree in medicine and experience as a physician or academic; Extensive experience in designing, monitoring and implementing clinical trials and interpreting trial results; Significant experience in advanced research and development; Therapeutic area expertise and commercial understanding; Thorough understanding of pharmaceutical safety, reporting and surveillance processes
• Desirable: PhD in scientific discipline; Extensive general medical knowledge

Key Relationship to reach solutions:
• Internal (to AZ or team): Senior Physician Team and Development function; Development leaders; Pharmacology; Pharmaceutical Development; Regulatory Department; Quality
• External (to AZ): External service providers and regulatory bodies

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 authorization and employment eligibility verification requirements.