Director, Medical Affairs

hace 2 semanas

Barcelona, España Novartis A tiempo completo

Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.
The Director, Medical Affairs will focus on implementation of global Managed Access Programs (MAPs) including Post Study Drug Supply (PSDS) and assigned responsibility in medical affairs. This role is expected to manage MAP/PSDS requests for 80% of time and 20% for medical affairs activities.
Managed Access Program (MAP) intent is to provide access to treatment for patients with a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapy available to monitor or treat the disease or condition. Terminologies such as Compassionate Use Programs (CUPs), Early or Expanded Access Programs (EAPs), Named Patient Supply (NPS) etc., have different definitions and meanings in different countries. The various mechanisms for such supply are collectively described under the umbrella term ‘Managed Access Programs (MAPs)’ in Novartis global procedures.
Post Study Drug Supply (PSDS) is one of the mechanisms of Post-Trial Access (PTA), as defined in Novartis global guidelines, to provide study treatment to patients who complete participation in a Novartis-sponsored clinical trial.
For medical affairs, clinical research (company trials, real world evidence, research collaboration, investigator-initiated trials)
Your responsibilities include, but are not limited to:
**Your responsibilities**:
Managed Access Program
- To complete review of a new MAP request within two working days following receipt of all required information with escalation as required.
- Create MAP treatment plan for compounds, in co-ordination with line functions including program safety
- Development of patient consent, product forecast & other relevant activities
- Creation of product form that determines eligibility of MAP patients
- Prepare/update cover letter to append to IB highlighting any additional compound-specific information (e.g. risk minimization) consulting global program safety as needed.
- Review MAP treatment plan, patient consent and product form on an ongoing basis (at a minimum annually) for any relevant updates.
- Communicate decision to close MAP to participating countries and complete a MAP Closing Report within 12 months.
- Prepare MAP reports for any Health authority submissions.

Post Study Drug Supply
- Develop a PSDS treatment plan in accordance with the study.
- Create PSDS-specific Patient Consent with input from relevant line functions including global program safety
- Develop PSDS cover letter to highlight any new or additional compound-specific information for the physician (e.g. relevant risk minimization materials)
- Review the PSDS Treatment Plan and the PSDS-specific Patient Consent Requirements on an ongoing basis (at a minimum annually) for any relevant updates and liaise with global safety regulatory and other relevant line functions, as needed
- Complete a PSDS Closing Report within 12 months from the Last Treatment Date of last patient.

Medical Affairs
The 20% responsibility in medical affairs would be selected, depending on the business need and priorities:

- Execute medical affairs strategy for all programs in key countries including transformation tactics such as: research/population health, innovative partnerships and integrated evidence plans.
- Partner with Medical Affairs organizations in key countries to ensure strong delivery focus on country needs.
- Co-develop plans for evidence generation, MSL / Field Medical Affairs strategy, medical education programs, scientific publication planning and Medical Expert network development with TAs.
- Partner with Development, Value & Access & TAs to shape launch portfolio and diversify evidence to achieve broad access at launch and to enhance impact on clinical practice.
- Provide input to shape Field Medical Strategies, develops, and executes Field Medical plans, ensure implementation of key Field Medical initiatives, e.g., insight gathering, sharing and translation into action, development and conduct of trainings on disease area and medical/ scientific knowledge, and guides MSL deployment.
- Ensures GMA activities are designed and executed in compliance with company policy guidelines and highest medical quality standards.

The role can be based in Spain, UK or Ireland.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patien

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