Medical Affairs Development Head

Almost 1 billion That’s how many lives our product touches globally.
We aspire to get Novartis medicines in the hands and homes of patients by delivering a Triple Win: A Win for Patients; A Win for Healthcare Systems, and A Win for Novartis.
The Medical Affairs Development Head is a key end to end role that will involve the development and effective execution of local evidence generation to ensure that the Medical Affairs strategies and TA´s investigational objectives are met. Additional to that, provide direction and supervising to local clinical operations team within MedEx & Gov. Dpt., Country Medical Head and TMO. On top of that, will be responsible for the planning, management, and delivery of local clinical trial at the country level within MedEx & Gover. Department in collaboration with local and global stakeholders (including Regional/Global Clinical and Trial Operations Management teams), to ensure effective execution and completion of trials with high quality, ensuring full alignment with the strategic needs of the Medical Affairs Unit at the CPO level.

**Your key responsibilities**:
**Your responsibilities include, but are not limited to**:

- Head and coordinator of the contracting of external associates (CSM/Clinical Study Manager), follow-up with CRO to guarantee the delivery, implementation, and compliance with the established procedures in accordance with GCP, GPP, ICH and local regulations, ensuring the collection of high-quality data and ensuring all deadlines and budget targets are properly fulfilled.
- Coordination and consistency of cross therapy area (TA) studies medical affairs department. Define project tasks and resource requirements.
- Act as a point of contact for the medical local team, initiating, approving, and monitoring NVS sponsored, Research Collaborations and IITs studies. To bring medical and technical expertise to the medical affairs team, relevant brand teams, and other internal business partners including regulatory, strategic development.
- Manages Development trial monitoring issue identification, escalation and resolution aligned with the MedEx & Gover. Head, Country Medical Head, TMO Head and by partnering with Development/Country QA, as applicable.
- Identifying study-related regulatory and quality issues and managing complaints and any subsequent legal actions.
- Driving excellence of medical affairs operations and processes including quality control and assurance to ensure audit/inspection readiness.
- Assuring compliance with SOPs and local regulations, checking that all processes are correctly documented and updated. Delivery of quality data and compliance to quality standards.
- Coordination of the hiring the external associates, follow up with the CROs. Review with CRO the tracks performance through key performance external associates' indicators to assure end to end delivery of key milestones.
- Partners with Country medical Development Unit to create competitive advantages allowing for an adequate footprint of trials and patients.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:
**Essential**:

- Education: bachelor's degree in life sciences required. Advanced Degree in scientific or business preferred.
- Practical knowledge of regulatory affairs (sound understanding on GCP and SOPs), quality assurance or pharmacovigilance will also stand you in good stead.
- Fluent English (oral and written) as well as Local language.
- At least 5 years' experience in clinical research, in planning/executing and/or monitoring clinical trials and 3rd parties’ study with at least 2 years in a people management role.
- Excellent understanding of all aspects of clinical drug development and NIS with particular emphasis on trial execution and monitoring
- Thorough understanding of the international and national aspects of drug development process and NIS, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations
- Strong capability in working in a Local/Global/Country matrixed environment.

**Desirable skills**:

- Training on Evidence Based Medicine and/or clinical epidemiology
- A strong, motivational leader, with experience leading a multi-level team
- Team player, problem solver with clear focus on end result
- Excellent in written and oral communication skills

**Why Novartis?**

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working