WorldWide Medical Affairs Director Cardio Renal Metabolic

WorldWide Medical Affairs Director Cardio Renal Metabolic

Job Description

26 million patients suffer from heart failure all over the world and still face challenging unmet needs. Novartis has been a leader in the field, reimagining care for patients living with heart failure for more than a decade. Our commitment to patients and science through the most extensive heart failure drug development program has brought singular innovations for these patients, allowing those with heart failure and a reduced ejection fraction to live longer and more fulfilled lives. In the coming years we will continue to add value with the execution and readout of breakthrough outcome clinical trials and top-class heart failure registries looking into heart failure with preserved ejection fraction and heart failure prevention in high risk patients. Furthermore, through our continued investments in R&D and our partnering’s with visionaries in digital innovation we will continue to push the boundaries in cardiovascular disease research and remain a trusted partner for scientific societies, healthcare practitioners and patients.

As our WorldWide Medical Affairs Director, you will be responsible for providing medical and scientific leadership into medical brand teams and other brand related functions from pre-launch through the whole life cycle of the compound. You will support the Global Brand Medical Director in the execution of Global Medical Affairs (GMA) activities in alignment with GMA & across-brand functions

Your responsibilities will include:
• For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input to, e.g.:
− Key activities related to planning, execute and report Global Medical Affairs studies and ensure timely and on budget delivery
− Develop study-related documents (e.g. concept sheets, protocols, case report forms, data analysis plan, study reports, publications)
− Develop presentation material for study-related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations and speaker at meetings
− On-going review clinical study data, final analysis and interpretation, in collaboration with the Brand Safety Leader, appropriate Global Clinical Team members and the GBT (Global Brand Team)

• Serve as a disease area scientific and medical expert for internal customers/stakeholders with a particular focus on drug safety and lifecycle management
• Build together with the (Portfolio) Global Brand Medical Director a highly influential medical and scientifically based platform:
− Program/brand(s) publication plan and ensure execution in collaboration with assigned Medical Communication Leaders, e.g. provide input on scientific content, support/lead data mining activities and support review processes associated with execution
− support/ lead internal and external medical education and communication initiatives (e.g., speaker training, advocacy, Key Opinion Leaders strategy, advisory boards, launch support, congress planning and execution)
• Provide medical scientific input for the assigned program/brand(s) to:
− Develop integrated Product Strategy, MA strategy and related MA plan
− Develop Clinical Development Plan (section related to MA activities)
− Lead Medical Affairs Study Team to provide guidance to CPOs related to their MA study program; review, approve and follow up on local MA studies

Minimum requirements

What you’ll bring to the role:
• PhD with unique knowledge for successful clinical program development and execution, with ≥ 6 years of clinical research experience required.
• MD with specialty with board certification or equivalent with ≥ 3 years of clinical research experience.
• Fluent English (Oral and Written)
• Medical and/or scientific expertise within a disease area required
• Proven ability to interpret, discuss and represent efficacy and safety data relating to the assigned area
• Proven ability to work both independently or in a cross-functional team setting, including a matrix environment
• Demonstrated ability to establish strong scientific partnership with key investigators in assigned TA
• Advanced medical/scientific writing and communication skills.

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

We are Novartis. Join us and help us reimagine medicine.
Novartis Pharma AG
Research & Development
Full Time