Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

General Description of the Role

The Executive Medical Director (EMD) role is generally assigned to be responsible for overseeing 2 or more programs, providing oversight/guidance/mentoring to the Medical Directors and Clinical Development Scientists on the teams, serving on cross-asset strategic teams (e.g., disease strategy team) and providing input to strategic decisions at the TA Strategy Team and Global Medicine Team meetings.

Generally, the role may include managerial responsibilities over Senior Director, Medical Director Clinical Development directly and may support / oversee other Medical Directors/Clinical Development Scientists that report indirectly to the Executive Medical Director.

The EMD may support development of regulatory strategy, therapeutic area and other functional strategies.

Specifics of the specialized role

The Early Development Clinical Lead (EDCL)-EMD, Clinical Development is a specialized role within the EMD, and is specifically designated to provide medical leadership and input to Program Teams during the early stage of drug development (i.e., transitioning molecule through IND/CTA and First-in-Human study stage to Proof-of-Concept and End-of-Phase-2 stage). The incumbent will serve as one of the medical experts for the study team(s) and may serve as the medical monitor for phase 1b-2a/b clinical trials.

Additionally in line with its seniority, the Hematology EMD is typically responsible for multiple clinical development programs in a therapeutic area spanning IND to POC/Phase 2/3 under the supervision of a VP Clinical Development TA Head. In addition, they may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target) and keep close ties with the Discovery and Research organizations.

In line with its seniority, the EDCL-EMD is typically responsible for multiple clinical development programs in a therapeutic area spanning IND to POC/Phase 2 under the supervision of a VP Clinical Development TA Head. In addition, they may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target) and keep close ties with the Discovery and Research organizations.

This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

You will be responsible for:

• Typically lead 2 program teams and drive the successful execution of clinical studies / programs / research strategies; define and manage the benefit to risk profile of our products
• Represent Clinical Development on the Global Program Team (GPT) and GLobal Medicine Team in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee); advance understanding of the impact our therapies have on the pathophysiology of rare and orphan diseases through scientific discourse and interpretation of data
• Foster development of Medical Directors and CDS and/or fellows. Lead and oversee 2 programs and the preparation and execution of a clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Provides scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads and or oversees clinical activities to support due diligences
• Represent Alexion Clinical Development to internal (R&D management, cross functional development teams and executive committee) and external (academic, regulatory, and medical) communities.
• Oversee a cross functional team which develops the clinical components of the CDP. Serve as the Clinical input to Global Development Team / Subteams and medical expert for the clinical study team. Oversees the writing of the clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses
• Liaise internally with other members of the CDP to drive program strategy and CDPs. Coordinate communications and planning bet medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution and interpretation of results. Serves as the medical expert on the global product labeling team
• Drive 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
• Write or contribute to white papers, expert opinion reports, and regulatory responses
• Drive clinical support of 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
• Determine appropriate advisory boards experts
• Working 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

You will need to have:

• Required: M.D. or equivalent

• 7+ years of experience in clinical development; clinical research, global regulatory, and product development expertise
• Has prepared documents and attended regulatory meetings with FDA and other regulatory agencies
• Experience designing and executing multinational clinical trials required
• Demonstrated ability to lead cross-functional teams to define clinical strategy and clinical study design
• Experience supporting business development activities
• MD or equivalent, preferably with clinical training
• PhD in related discipline desirable, but not required
• 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.

We would prefer for you to have:

• Board certified hematologist
• 5+ years of management and/or team leadership experience
• Has prepared documents and attended regulatory meetings with FDA and other regulatory agencies
• Experience designing and executing multinational clinical trials
• Demonstrated ability to lead cross-functional teams to define clinical strategy and clinical study design
• Experience supporting business development activities
• 7+ years of clinical development industry experience
• Preferred: Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.

#LI-JC1

#LI-HYBRID

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.