Medical Science Director
AstraZeneca Mölndal / Läkarjobb / Mölndal
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hela Sverige Medical Science Director for saxagliptin and dapagliflozin, CVMD GMed
The role
The Medical Science Director (MSD) for saxagliptin and dapagliflozin is a core member of the Global Product Team (GPT) and is responsible for the benefit risk of the products, the Medical Scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), and core labelling texts and will provide medical input into commercial activities and the scientific component of the pricing and value strategy. The MSD leads the Clinical Product Team and has accountability for the clinical deliverables to time and quality.
Accountabilities
Clinical Product Team
• Leader of Clinical Product Team (CPT) and overall accountable for the CPT deliverables.
• Overall clinical and scientific content for the products.
• Ensure the CPT rapidly implements new processes and systems and learning.
• Medical prioritisation of clinical activities within their clinical program.
• Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GCP.
• Ensure internal and external peer review of potential study/program design. As available, provide clinical strategic input to in-licensing opportunities.
• Broad leadership role across the Business.
Global Product Team
• Timely provision of Medical Scientific strategies for clinical components of the TPP, TPC, CDP, and core labelling texts.
• Medical input into commercial activities.
• Timely provision of scientific component of the pricing & value strategy.
Responsibilities
Global Product Team
• The ethical and scientific integrity of the plans, studies and the product.
• The risk management plan of the Program, together with Patient Safety.
• High level strategic internal and external interactions including Academic collaborations and Key Opinion Leader & key centres development and support.
• Support rapid implementation of new processes & systems through their Program.
• Ensure the Program clinical strategies and plans receive peer review to assure quality.
• Support as appropriate within the Program during issue & crisis management, as directed by the Diabetes/Metabolism and GI Clinical Vice President.
• Represent the Company at meetings with Regulatory Agencies and Governmental bodies.
• Represent the Company at meetings with external scientific fora, clinical investigators and other clinical personnel.
• Medical representation at internal governance groups.
• Medical input into commercial activities.
• Timely provision of scientific component of the pricing & value strategy.
Clinical Project Team
• Clinical strategy to meet development decision points/TPP/TPC and target labeling.
• Clinical contribution to Regulatory and Governance documents.
• High level strategic external interactions including academic collaborations, key opinion leaders & key centres development and support.
• Delivery of Medical Science components to the Program to time and quality.
• The Risk Management Plan, Periodic Safety Updates, SaMT and SERM, together with Patient Safety.
• Ensure the Program clinical strategies and plans receive peer review to assure quality.
• Lead and develop Study Team Physicians working on their Projects.
Information: Nayyar Iqbal at +1 215-823-9420. Welcome with your application via
www.astrazeneca.se no late June 8.
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2015-05-27ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-06-08
Ange följande referens när du ansöker: MOL000001RV
FöretagAstraZeneca Mölndal
AdressAstraZeneca Mölndal
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 2311856
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