Senior Director, Clinical Development
hace 2 semanas
**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 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 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
- 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.
-
Senior Renal Clinical Development Director
hace 2 semanas
Barcelona, España Novartis A tiempo completoA leading global pharmaceutical company is seeking a Clinical Development Director in Barcelona.Haga clic en "Solicitar" a continuación para enviar su candidatura. Asegúrese de que su CV está actualizado y de que ha leído primero las especificaciones del puesto.The role involves leading clinical programs, ensuring data quality, and collaborating with...
-
Clinical Development Medical Director
hace 1 semana
Barcelona, España Healthcare Businesswomen’s Association A tiempo completoClinical Development Medical Director - CRMPor favor, lea detenidamente la siguiente descripción del puesto para asegurarse de que encaja con el perfil antes de enviar su solicitud.Job Description SummaryAre you passionate about shaping the future of clinical development and making a meaningful impact to patients?Job DescriptionWe are looking for an...
-
Senior Clinical Program Director, Early Clinical
hace 3 días
Barcelona, España AstraZeneca A tiempo completoThe Senior Clinical Program Director (Senior CPD) is accountable for the overall delivery of the clinical program to time, cost and quality and is the leader of the Clinical Program Team (CPT). The Senior CPD will be required to work closely with the core CPT members to ensure that the clinical strategy and deliverables for the clinical program are delivered...
-
Clinical Development Medical Director
hace 1 día
barcelona, España Healthcare Businesswomen’s Association A tiempo completoClinical Development Medical Director - CRM Job Description Summary Are you passionate about shaping the future of clinical development and making a meaningful impact to patients? Job Description We are looking for an experienced and visionary Clinical Development Medical Director (CDMD) to take the lead in driving the strategic planning and execution of our...
-
Clinical Development Director
hace 2 semanas
barcelona, España Novartis A tiempo completoSummary The Clinical Development Director (CDD) is the clinical/scientific expert and, if assigned, the clinical development lead of a section of a global clinical program and/or trial (e.g., an indication, a new formulation, or a specific development phase) or a large, complex trial, under the leadership of the GPCH. The CDD may be assigned to have a team...
-
Senior Director Clinical Scientist
hace 1 semana
Barcelona, España AstraZeneca A tiempo completoAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies. AstraZeneca has a multifaceted environment that cultivates...
-
Clinical Development Director
hace 2 semanas
Barcelona, España Novartis A tiempo completoSummary¡Inscríbase sin demora! Se espera un gran volumen de solicitantes para el puesto que se detalla a continuación, no espere para enviar su CV.The Clinical Development Director (CDD) is the clinical/scientific expert and, if assigned, the clinical development lead of a section of a global clinical program and/or trial (e.g., an indication, a new...
-
Barcelona, España AstraZeneca A tiempo completo**Senior Global Clinical Operations Program Director** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Join a...
-
Clinical Director
hace 18 horas
Barcelona, España Heidi A tiempo completo**Who are Heidi**: Heidi is building an AI Care Partner that supports clinicians every step of the way, from documentation to delivery of care. We exist to double healthcare’s capacity while keeping care deeply human. In 18 months, Heidi has returned more than 18 million hours to clinicians and supported over 73 million patient visits. Today, more than...
-
Senior Clinical Project Manager
hace 18 horas
Barcelona, España Neuroelectrics A tiempo completoWe are looking for a Senior Clinical Project Manager who will have the responsibility is to oversee the clinical investigations (pilot & pivotal) sponsored by Neuroelectrics. Start date: ASAP The Senior Clinical Project Manager is the main responsible of the specific clinical investigation sponsored by Neuroelectrics (pilot & pivotal studies) in US, being...
