Clinical Development Sciences, Medical Director

Position Summary
The Medical Director may lead a cross functional team in the design and execution of a clinical
study and may provide input into the global clinical development plans and strategy for a
therapeutic area. The job holder supports assigned clinical development physician(s) and the
therapeutic area head with deliverables necessary for effective and efficient clinical
development plan design and execution and therapeutic area strategy. Responsible for the
design and execution of 1 Ph3 or 2-3 smaller studies and for ensuring subject safety and is the
co-leader of the clinical study team (with clin ops). May supervise or provide medical oversight
for other associates.
Principal Responsibilities
• Lead a team in preparation of clinical study related documents including protocols,
charters, statistical summary reports, meeting presentations, publications, and
clinical sections of regulatory documents (may manage several studies in parallel).
• Lead a study team to design a clinical protocol, including engaging with relevant
internal and external stakeholders; responsible for preparing materials and protocol
defense presentation for C-PRC review. Represent the clinical study team at the
clinical subteam.
• May supervise and develop Medical Directors and CDS in preparation of clinical
study related documents including protocols, charters, statistical summary reports,
meeting presentations, publications, and clinical sections of regulatory documents
P a g e 2 o f 4
• Participate in Investigator meeting planning and execution and/or on-site initiation
meetings
• Lead the execution of clinical trials; Monitor, clean, analyze and review safety and
efficacy data to establish the presence or absence of trends and follow up as
appropriate.
• Lead a team in study execution, including country and site selection, site training
and start-up and data monitoring; expertise in data analysis and presentation
required. Depending upon specific expertise in translational science, may lead a
translational sub team of the clinical team. Serve as the Medical Expert for clinical
study team.
• Liaise with other functions to design external expert consultations, contribute to the
development of study concepts and designs, protocols and study essential
documents. Engage with clinical investigators nonclinical studies to enable quality
clinical execution, analyze and interpret clinical data, and collaborate with the
broader team to define clinical and therapeutic area strategy. Engage with
investigators, site staff, CROs, and site monitors to maintain enthusiasm and support
enrollment for ongoing clinical studies. Where appropriate, serve as the SME for
identification, translation, inclusion, implementation and reporting related to liquid,
tissutal and/or imaging endpoints.
• Lead the execution of clinical trials and associated data collection activities,
providing guidance to the clinical study team related to:
o country and site feasibility assessments and selection
o site training and oversight
o patient recruitment
o ongoing data monitoring
o study closeout
• 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 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
o Help to determine appropriate advisory boards experts
P a g e 3 o f 4
• Provide support for business development activities, such as due diligence and research
collaborations
• May serve as the Translational Science lead for one or more programs
Qualifications
• MD or equivant
• History of industry or academic clinical or basic science research
• Excellent written / oral communication skills
• Ability to think strategically
• Willingness to take on new responsibilities
• Attention to detail
• Interest in career progression and ability to take on a more senior role in 1-3 years
Education
• Required: M.D. or equivalent
• Preferred: Advanced knowledge of the assigned therapy area is desired, with the
capability to interpret, discuss and represent trial or program level data.
• 2+ years of industry experience in clinical development is preferred
Competencies
• Previous clinical trial experience as medical monitor in industry setting (Safety medical
monitoring and reporting experience; Protocol development experience; Understanding
of regulatory requirements related to clinical trials & Basic statistical knowledge)
• Subspecialty certification
• Board Certification
• Business development experience
• Understanding of general (and specific) therapeutic principles
• Knowledge in the principles of clinical research methodology, statistics, data analysis
and interpretation
• Familiar with scientific literature searches and weighing of quality peer reviewed data
• Ability to clearly communicate to internal and external stakeholders orally and in writing
P a g e 4 o f 4
• For those assigned to clinical endpoint support, e.g., imaging, experience in at least one
meaningful modality, e.g., ultrasound, computerized tomography, magnetic resonance,
positron emission tomography
• Specific therapeutic area experience
• Basics of strategic vs. tactical thinking
• Experience in 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

Date Posted
23-May-2024

Closing Date
25-Aug-2024Alexion 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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.