Executive Medical Director, Clinical Development, Hematology, Nephrology, & at AstraZeneca

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development, Regulatory Strategy, Cross-Functional Team Leadership, Clinical Research, Medical Monitoring, Program Management, Data Interpretation, Business Development, Therapeutic Area Expertise, Clinical Trial Design, Scientific Discourse, Mentoring, Due Diligence, Risk Management, Stakeholder Engagement, Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

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 EMD is a specialized role and is specifically designated to provide medical leadership and input to Program Teams during the early to late 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 and beyond). The incumbent will serve as one of the medical experts for the study team(s) and may serve as the medical monitor for clinical trials as necessary. In line with its seniority, the 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, she/he 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 leading 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 Representing 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 Fostering 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. Providing 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 Representing Alexion Clinical Development to internal (R&D management, cross functional development teams and executive committee) and external (academic, regulatory, and medical) communities. Overseeing 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 Liaising 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 Driving 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 Writing or contribute to white papers, expert opinion reports, and regulatory responses Driving clinical support of business development activities, such as due diligence and research collaborations Critically evaluating 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: Preferred: Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data. 7+ Years of experience in industry in clinical development is preferred Date Posted 14-Dec-2025 Closing Date 26-Apr-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Executive Medical Director will oversee multiple clinical development programs and provide medical leadership throughout the drug development process. Responsibilities include leading program teams, representing clinical development in strategic meetings, and fostering the development of medical staff.