Senior Medical Director Clinical Development Cell Therapy

This is what you will do:

The Senior Medical Director (Cell therapy) will lead the clinical sub-team and the global program team to build global clinical development plans and contribute to developing asset-level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for late-stage programs, leading the clinical subteam to the GPT, representing clinical development on the GPT, contributing to the development of regulatory strategy, and being the clinical spokesperson at regulatory meetings, and provide medical oversight in the interaction with other disease areas.

You will be responsible for:

• Lead or support the clinical sub-team and oversee the design and execution of multiple clinical studies or programs in benign auto/allo-immune derived conditions.

• Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee).

• Supervise and develop Medical Directors, CDS, and/or fellows; lead a clinical subteam and oversee the preparation of a clinical development strategy. May lead one or more clinical study teams in preparing clinical study-related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.

• Being actively involved in the selection and preparation of advisory board experts and help the team in preparation for meetings.

• Critically evaluate available information about diseases of interest, the competitive landscape and summerise information to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.

• Lead the clinical sub-team and oversee multiple studies for a given program. Serve as the Medical input to the Global Medical Lead, and manage various studies for a program. Serve as the Medical input to the Global Development Team / Subteam and the Medical Expert for clinical study teams.

• Liaise internally with other clinical development team members from the selection of the indications in concert with early commercial beginning of (including ClinDev Scientists, Clinical Project Leads or Biometricians) to drive overall program strategy and development plans. Represent Clinical Development at the Global Program Team.

• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

• Support business development activities, such as due diligence and research collaborations

• May serve as the Translational Science lead for one or more programs.

• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and summarise information to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.

• Work as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management

• May supervise other medical monitors on individual studies.

• Will frequently interact with multiple stakeholders in AstraZeneca ORD, Biopharma and China, and with external parties (ie.: KEEs, Centers of excellence, regulatory bodies and providers)

You will need to have:

• Medical Doctor

• Specialty in Haematology

• Experience and deep knowledge in CAR-T practice and clinical development and ideally in haemopoietic cell transplantation

• > 5 years of clinical experience with a minimum of 3 years of industry experience

• Desirable, but not strictly required, publication in peer-reviewed journals

• Excellent written/oral communication skills

• Attention to detail and ability to think strategically

• Willingness to take on new responsibilities

• Interest and ability to learn about new therapeutic areas

• Interest in career progression and ability to take on more senior roles in 1-3 years

• 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 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.

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. In-Office Hybrid This role has an expectation of working in the office a minimum of 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. Inperson 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.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.