Senior Director, Clinical Development

4 weeks ago

Dublin Pike, Ireland AstraZeneca Full time

Overview You will be responsible for:

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).

Fostering development of Medical Directors and CDS and/or fellows.

Leading 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 or oversees clinical activities to support due diligences.

Working 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) as it relates to clinical development study design, execution and interpretation of results. Serves as the medical authority 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.

Working as part of a cross-functional team with colleagues from biostatistics, data management, clinical pharmacology, commercial, regulatory and project management.

You will need to have
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

We would prefer for you to have
Specialty and/or practice in Cardiology, Metabolic Diseases and/or Amyloidosis

PhD in related subject area

Academic appointment(s)

Publications (peer reviewed) and presentations record

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

5+ years of Industry experience

Experience preparing documents and attended 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

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 nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

#J-18808-Ljbffr

  • Urgent! Leadership

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Ltd Full time

    Leadership & Talent Development Director - Dublin - Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Job Title: Director, Leadership and...

  • ▷ High Salary! Clinical Pathologist

    15 hours ago

    Dublin, Ireland ICON Clinical Research Ltd Full time

    Clinical Pathologist - Medical Director, Lab - Hybrid -Dublin, Ireland ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. ICON Clinical Laboratories is...

  • Senior Director Billing And Cash Collections

    4 weeks ago

    Dublin, Ireland Icon Clinical Research Full time

    OverviewSenior Director Billing and Cash Collections.ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Senior Director Billing & Cash CollectionsWe are...

  • Senior Director Billing And Cash Collections

    2 weeks ago

    Dublin, Ireland Icon Clinical Research Full time

    OverviewSenior Director Billing and Cash Collections.ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Senior Director Billing & Cash CollectionsWe are...

  • Fs Tax Directors

    3 weeks ago

    Dublin, Ireland Director File Full time

    We are working with the head of FS tax to help hire a Financial Services Tax Directors and Associate Directors to join their rapidly growing financial services tax team.Our client is the fastest growing firm in Ireland and has over **** people in 10 offices across Ireland, the Isle of Man, Gibraltar, and Bermuda, with a presence in over 130 countries around...

  • Only 24h Left: FS Tax Directors

    4 weeks ago

    Dublin, Ireland Director File Full time

    We are working with the head of FS tax to help hire a Financial Services Tax Directors and Associate Directors to join their rapidly growing financial services tax team. Our client is the fastest growing firm in Ireland and has over 3000 people in 10 offices across Ireland, the Isle of Man, Gibraltar, and Bermuda, with a presence in over 130 countries...

  • Senior Director of Regulatory Affairs

    3 weeks ago

    Dublin Pike, Ireland Panda International Full time

    Overview Director / Senior Director, Regulatory Affairs – Europe Location: Ireland (onsite presence required, hybrid flexibility) Therapeutic Area: Rare Diseases We are supporting a fast-growing biopharmaceutical company developing transformative therapies for rare diseases . With an established global operations and expanding European presence, the...

  • Medical Director

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Ltd Full time

    Medical Director - Oncology ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Medical Director (Oncology) to join our...

  • Senior Clinical Psychologist

    4 weeks ago

    Dublin Pike, Ireland Allied HealthNursing Full time

    Senior Clinical Psychologist – Full-time/Part-time (Hybrid) Our client is expanding, and are seeking a Senior Clinical Psychologist to join their dedicated team in North Dublin . If you have a passion for working with children and specialise in autism and ADHD assessments , this role offers a fantastic opportunity to contribute to a supportive and...

  • Assistant Director

    3 weeks ago

    Dublin, Ireland Healthcarejobs.Ie Full time

    Assistant Director & Nursing Director & Clinical Nurse ManagerAssistant Director of Nursing, Clinical Nurse Manager & Director of Nursing opportunities across IrelandImmediate Interviews and best DON, ADON, CNM jobs in IrelandJob DescriptionGreat opportunity for Assistant Director of Nursing & Clinical Nurse Managers to "Step Up" or relocate nationwide in...