Medical Director, Clinical Development Neurology

This is what you will do:

We are looking for a Neurology medical expert who will be responsible for the clinical development of neurology assets. This position offers substantial opportunities to work with cross-functional project teams and gain in-depth clinical development experience. .

You will be responsible for:

• Medical Expert and clinical development leader accountable for the clinical study design, protocol development from concept to final implemented protocol for assigned programs
• Protocol execution including interaction with investigators, and contributing to data review, data analysis and the preparation of final clinical study reports.
• Strategic guidance to phase II/IIIdevelopment programs and oversight of global clinical trials/trial team (s) in conjunction with Clinical Operations on assigned program(s)
• Provide medical monitoring for assigned programs and assessment of safety events in conjunction with Safety teams
• Represent clinical team on the cross-functional program team accountable for medical input to interated development plan
• Development of medical content for regulatory document, and responses (including but not limited to pre-IND, IND briefing packages and common technical documents)
• Lead identification and external engagement with key opinion leaders for assigned programs including at advisory meetings,  investigator meetings and patient advocacy organizations
• Contribute to the medical assessment of business development opportunities for rare neurology programs and provide clinical input for early (assets in non-clinical development or phase 1)

You will need to have:

• MD, DO, MBBS (or equivalent) degree with relevant clinicant speciality for the the therapeutic area
• 3+ years  clinical research expertise in neurological diseases with pharmaceutical/CRO industry experience in drug development
• Excellent written / oral communication skills
• Ability to think strategically and translate strategy into tactical plans to drive outcomes
• Must be adaptable, able to prioritize and manmage time effectively
• Willingness to take on new responsibilities and roles
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Willing to travel to scientific meetings

We would prefer for you to have:

• Clinical or research experience in dementia (neurodegenerative disorders could be possibility) preferred
• Rare Disease clinical development experience
• Previous clinical trial experience as medical monitor in industry setting
  • Safety medical monitoring and reporting experience
  • Protocol development experience
  • Understanding of regulatory requirements related to clinical trials
  • Basic statistical knowledge

• Board Certification in Neurology
• Business development experience
• Publication in peer reviewed journals

Senior Medical Director, Translational Medicine, Neurology

Introduction

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 neurologic clinical studies, collaborating with cross-functional teams to support translational and experimental medicine.  The role will focus on neurologic rare diseases across the Neurology Therapeutic Area (TA) and Genomic Medicine Development Unit at Alexion. 

The ideal candidate will have a strong background in translational medicine, with a focus on neurology rare diseases and preference with experience in rare diseases.

What You Will Do

• Create and execute translational science and experimental medicine plans

• 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 Development organization to support the transition from Research to the DRS Development organization in preparation for IND

• Partner with Translational Research team to drive connectivity between the Research and Development organizations

• Support cross-functional teams on IND-enabling studies

• Support the design of early clinical trials through Proof-of-Concept, including experimental medicine studies

• Through collaboration, design and execute translational plans (including clinical biomarkers supporting target engagement, MoA, and proof of biology, across various modalities), to support clinical development programs.

• Develop and implement patient enrichment strategies to support the core aspects of the program

• Prepare and review study protocols, clinical study reports, and translational medicine sections of plans, abstracts, and technical reports

• 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.

• Present results and updates of projects at department, project, corporate, and scientific meetings.

• Stay updated on the latest advancements in neurologic translational medicine and rare disease research, incorporating new knowledge into ongoing projects.

Who You Are

• Medical Degree (MD) with board certification/board eligible in Neurology is Required; In addition PhD or strong research experience is preferred.

• Minimum of 3 years in early clinical development, translational medicine or translational research in an industry setting; exceptional individuals with academic trial/research experience will be considered.

• In-depth knowledge in a core neurology specialty area with broad understanding of the wider scope of neurology diseases is strongly preferred. 

• Proven competence in clinical therapeutics, drug development, and early clinical development.

• 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.

Working at Alexion

We’re inspired to think differently, to create better outcomes. By creating an unparalleled employee experience, our organization is equipped to adapt and enrich employees with a productive, engaging, and enjoyable work experience, while accelerating world-class leadership and innovation capabilities that can deliver on our mission. Each of us is accountable for delivering innovative medicines and supportive technology with integrity so we can truly understand and better the lives of people affected by rare diseases. Together, we can transform lives every day.

The Highest Standards

By operating with the highest standards of ethics and integrity, we aspire to live up to the expectations of patients, physicians, and ourselves, and to earn trust in our communities.

Diversity

We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other, working together as a high-performing team to deliver extraordinary results while embracing different perspectives.

Dedication

The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation, and to redefine what it means to live with a rare disease.

This role has an expectation of working in the office 3 days a week. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.