Clinical Development Sciences, Medical Director Cell Therapy

As a Medical Director, you will have the opportunity to shape global clinical development plans and therapeutic area strategies. You will lead all aspects of the clinical development strategy for one project, lead the clinical sub-team, and represent clinical development at regulatory meetings and before external audiences. Provide mentorship to less experienced Clinical Development Scientists. Join us in making a difference in the lives of patients with rare diseases.

Accountabilities

• Lead or support he design and execution of one or more clinical studies with cell-based therapies.
• 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).
• Manage a clinical sub-team and prepare a clinical development strategy.
• May lead one or more clinical study teams in the preparation of clinical study-related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Determine appropriate advisory board experts and lead the team in preparation for meetings.
• Critically evaluate available information about diseases of interest to the disease area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy.
• Serve as the Medical input to the Global Development Team / Sub-team and the Medical Expert for clinical study team development!
• Liaise internally with other clinical development team members (including Clinical Dev Scientists and Clinical Project Leads) to drive overall program strategy and development plans. Represent Clinical Development at the Global Project Team.
• Maintain awareness of internal and external developments that could impact the development plan.
• Support business development activities, such as due diligence and research collaborations.
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly 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 biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management.

Essential Skills/Experience

• MD or PhD with Clinical Development experience
• Minimum of 5 years of Development experience, preferably within the industry
• Minimum of 3 years of industry experience for outstanding candidates
• Previous experience with advanced therapies
• Experience as a medical monitor or clinical operations in clinical trials
• Publication in peer-reviewed journals
• Excellent written/oral communication skills
• Willingness to take on new responsibilities

Desirable Skills/Experience

• Regulatory experience preferred
• Advanced knowledge of the assigned therapy area is desired (hematology, immunology, nephrology or neurology), with the capability to interpret, discuss and represent trial or program-level data.
• Experience for medical responsibilities on a cross-functional team preferred
• Understanding of general (and specific) therapeutic principles
• Experience designing and driving industry-sponsored clinical trials
• Broad experience in the principles of clinical trial methodology, statistics, data analysis and interpretation
• Expertise in scientific literature searches and weighing of quality peer-reviewed data
• Experience authoring study essential documents, Clinical Study Reports and regulatory documents
• Ability to communicate to internal and external collaborators orally and in writing
• Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Ability to prioritize multiple tasks and goals to ensure completion on time within budget
• Ability to think both strategically and tactically

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives 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.

At AstraZeneca's Alexion division, you will find an environment where your work truly matters. Our commitment to patients with rare diseases drives us to innovate continuously. We offer an entrepreneurial spirit combined with the resources of a global biopharma leader. Here, you will be part of a supportive community that values diversity, inclusiveness, and integrity. Your career will be a journey filled with opportunities for growth, learning, and making a real impact on patients' lives.

Ready to make a difference? Apply now!

Date Posted

18-Feb-2025

Closing Date

24-Feb-2025Alexion 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. ]]>