Global Study Associate Director – Sponsor Dedicated
IQVIA
Google Cloud Platform
Senior Director, Clinical Development
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Barcelona • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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)
- Foster development of Medical Directors and CDS and/or fellows
- Lead 2 programs and prepare/execute clinical development strategy and related documents (protocols, charters, statistical summary reports, meeting presentations, publications, clinical sections of regulatory documents)
- Provide scientific and medical input to other R&D, commercial, translational, medicine and business development functions; lead or oversee clinical activities to support due diligences
- Work internally with other members of the CDP to drive program strategy and CDPs
- Coordinate communications and planning between medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) for study design, execution and interpretation of results
- Serve as the medical authority on the global product labeling team
- Drive awareness of internal and external developments (scientific, clinical, competitive, and regulatory), attend major scientific conferences, participate in competitive intelligence activities, and conduct periodic literature review
- Work as part of a cross-functional team with biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
- Duties generally conducted in an office environment with standard business hours expectations
Requirements
- M.D. or equivalent
- 7+ years of experience (or academic or practice equivalent) in clinical development and/or clinical research and/or global regulatory, and/or product development expertise
- Preferred: Specialty and/or practice in Cardiology, Metabolic Diseases and/or Amyloidosis
- Preferred: PhD in related subject area
- Preferred: Academic appointment(s)
- Preferred: Publications (peer reviewed) and presentations record
- Preferred: Professional guidelines authorship or working group participation
- Familiarity (language skills would be a plus) with Asian (Japan and/or China) Medical Community and regulatory agencies
- Preferred: 5+ years of Industry experience
- Experience preparing documents and attending regulatory meetings with regulatory agencies
- Experience designing and completing multinational clinical trials
- History of leading cross-functional teams to define clinical strategy and clinical study design
- Experience supporting business development activities
- Ability to use a computer; engage in communications via phone, video, and electronic messaging; collaborate with others; maintain general availability during standard business hours
Benefits
- An inclusive environment where equal employment opportunities are available to all applicants and employees.
- If you have a disability or special need that requires accommodation, the employer will consider accommodations during the application process.
- Commitment to lifelong learning, growth and development for all employees.
- Inclusive culture and diversity initiatives (Championing Inclusion and Diversity).
- Emphasis on being a 'Great Place to Work' and a people-centered workplace.
- Opportunities to attend major scientific conferences and participate in professional development.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentclinical researchregulatory affairsproduct developmentclinical trial designstatistical summary reportsprotocol preparationpublicationspeer-reviewed publicationsmultinational clinical trials
Soft skills
leadershipcommunicationcollaborationcross-functional teamworkstrategic planningscientific inputmentorshiporganizational skillspresentation skillscompetitive intelligence
Certifications
M.D.PhD