The Medical Director, Clinical Development may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies.

Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings, as assigned by manager.

Key Responsibilities:

• Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs.
• Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees.
• Functionally, supervise and develop medical monitors and/or clinical development scientists (CDS), if any and as assigned by the manager.
• 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, as assigned by manager.
• Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents.
• Determine appropriate external experts for advisory boards, steering committees, adjudication committees, and/or data monitoring committees, and lead the team in preparation for meetings.
• 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.
• Serve as the Medical input to the Global Development Team/Subteam and the Medical Expert for clinical study team.
• Conduct medical monitoring activities during periods of vacations, team restructuring, team departures or in other situations, as assigned by manager.
• Lead the presentation of clinical trial related information/data to senior management, as assigned by manager.
• Liaise internally with other members of the clinical development team 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, as assigned by manager.
• May serve as the Translational Science lead for one or more programs, as assigned by manager.
• Working as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, safety, quality, and project management, or others, as assigned by manager.

Requirements:

• Physician with MD or foreign equivalent.
• 3-5 years of clinical development experience preferably within industry.
• 3-5 years minimum experience as a medical monitor for clinical trials required.
• Regulatory experience preferred.
• Track record of publication in peer-reviewed journals, preferably first-authored publications.
• 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.

Preferred Qualifications:

• Clinical specialty certification from US or foreign equivalent.
• Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss, and represent trial or program level data.
• 3+ years of industry experience in clinical development is preferred.
• Experience for medical responsibilities on a cross-functional team preferred.
• Formal training (certificate or graduate degree) in epidemiology, clinical trials, clinical research, biostatistics is strongly preferred.
• Broad experience in the principles of clinical trial methodology, statistics, data analysis, and interpretation.
• Understanding of general (and specific) therapeutic principles.
• Experience designing and executing industry-sponsored clinical trials.
• Expert in scientific literature searches and weighing of quality peer-reviewed data.
• Experience authoring study essential documents, Clinical Study Reports, and regulatory documents.
• Strong relevant therapeutic area experience.
• Ability to clearly communicate to internal and external stakeholders orally and in writing.
• Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.
• Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget.
• Ability to think both strategically and tactically.
• Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss, and represent trial or program level data.

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. In-person working

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The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation, and life cycle management of the assigned cell and gene therapy (CGT) product(s).

You'll serve as the global regulatory lead (GRL) on early-stage projects or be responsible for specific indications or jurisdictions of larger programs.

You'll have the opportunity to contribute significantly to product and clinical strategy and support cross-functional alignment for governance and health authority interactions.

The RAD also serves as the face of the company with Health Authorities.

Accountable for leading the development and implementation of the regional or global regulatory strategy for a CGT product/group of products.

Ensures that the strategy is designed for efficient development tailored to the global or specific regional regulatory environment(s), and to deliver approvals aligned to the needs of the business, markets and patients.

This includes optimising the health authority engagement strategy, aligning cross-functionally on messaging, planning the development of submission documents, and driving designation of applicable expedited regulatory programs such as FastTrack, RMAT, Breakthrough, and PRIME.

Lead cross-functional teams in major regulatory submissions (NDA, IND/CTA), Health Authority interactions, label negotiations, and securing NDA/BLA approvals.

This includes developing the strategy, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.

Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling, and members of the submission and execution team in formulating global regulatory strategy and delivering on NDA filings and approvals

As a regional regulatory lead, the RAD is accountable for providing the region-specific regulatory strategy and direction.

May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities

Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.

Lead preparation of the regulatory strategy document and target product labeling.

Demonstrate strategic leadership skills contributing to product development.

Provide team leadership in a matrixed environment and participate in coaching, and performance feedback to members of the GRST.

Lead the objective assessment of emerging data and regulatory environments against aspirations and update senior management on project risks/mitigation activities.

Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.

Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Essential for the role:

Bachelor's degree in a science related field and/or other appropriate knowledge/experience.

At least 5 years' experience in regulatory drug development or equivalent with a focus on cell and gene therapy products for malignant diseases.

Experience with major Health Authority interactions including direct engagements with US FDA/CBER.

Hands-on leadership of IND and pre-IND CGT programs.

A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

Demonstrated competencies of strategic thinking, influencing, innovation, initiative, leadership and excellent oral and written communication skills.

Desirable for the role:

Scientific background in area relevant to oncology cell and gene therapy development.

Understanding of non-clinical and CMC regulatory principles pertaining to CGT, including comparability and potency.

A solid grasp of guiding principles in drug development.

This includes benefit/risk profile, dose selection, and statistical development related to cell and gene therapy products.

It also involves using small datasets to support Health Authority alignment.

Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.

Contribution to a regulatory approval including leading response team and labeling negotiations

Ability to work strategically within a complex, business-critical and high-profile development program.

Critical thinking on current global regulatory science and policy pertaining to CGT, and good understanding of the corresponding scientific and clinical components.

Prior experience with phase 3 design including end of phase 2 health authority interactions

Office Working Requirements

When we put unexpected teams in the same room, we unleash 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.

The annual base pay for this position ranges from $178,534.40 - 267,801.60 USD.

Our positions offer eligibility for various incentives,an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

#LI-Hybrid

Date Posted 20-Apr-2026

Closing Date 03-May-2026

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