Oncology Medical Affairs Head Lazio

Oncology Medical Affairs Head
Roma
Lazio, Lazio

_ ACCOUNTABILITIES_

**Leadership**:

- Develops and defines, in alignment with the Global Medical Affairs Oncology team, the Italian medical/clinical strategy for the Oncology Division.

Oversees the implementation of these strategies and annual project plans.

Identifies and provides mitigation strategies for issues identified in therapeutic areas, responding strategically to internal and external drivers of change.

- Ensure Medical plans are aligned cross-functionally and aligned with the Division's strategy as well as delivered on time and on budget.

- Oversees development plans of all staff resources within the Oncology Medical Affairs therapeutic area.

Responsible for recruitment, training and performance management of talent within the therapeutic area.

Ensures all team members are trained on and act in accordance with applicable laws, regulations and policies as well as Takeda policies guidelines, quality assurance and compliance requirements.

- Guide on-boarding, training and knowledge transfer within the medical department providing an upskilling on areas of improvement as agreed within Oncology Country Head and Global Medical Affairs team.

- Lead local processes to hire new Oncology medical personnel.

**Medical/Scientific Affairs**:

- Responsible for adherence to Global / EUCAN Compliance Standards for the Non-Commercial (Scientific) processes.

- Guarantee scientific accuracy and adherence to ethical and industry standards regarding medical information, medical staff and sales force training, promotion of products marketed in accordance with the local Drug Law and Takeda's standards / SOPs.

- Oversee development of local tactical medical plans in line with the Oncology Division strategy and execution (including the production of local publications, planning and conduct of local Advisory Board meetings etc.

).

- Liaise with Oncology Marketing, Market Access and Scientific Information Leads/Heads to ensure common understanding of customer needs and alignment on applied strategy.

- Supervise the activity of the Medical Liaison Manager in the country, providing adive on HCP mapping and segmentation principles and KPIs system for MSLs.

**Clinical Research**:

- Final responsible person for the development of clinical research plan (both interventional and non-interventional, including RWE) according to gap analysis and in alignment with Global and local functions (i. e.

Patient Value and Access).

- Responsible for the scientific integrity, GCP adherence, (global) strategic alignment, safety, design, high quality and timely conduct of local clinical studies.

- Oversee the evaluation and support of local Investigator Initiated Sponsored Research (IISR) proposals to ensure global strategic alignment and execution in line with Takeda standards.

- Facilitate and support local GCP audits and inspections and oversee completion of GCP related commitments or CAPAs according to the agreed timelines.

**New Product Planning Activity**:

- Supervises all local activities connected with New Product Planning (L-60 to L-24) of all new launches in Oncology division, ensuring timely activation/start of key NPP activities.

- Based on regional asset prioritization, define assets to prioritize for local NPP (entering 5 years to launch timeline, newly licensed, acquired).

- Provide regular updates on NPP activities and provide recommendations on forecasts, pricing, commercial implications etc.

to local leadership for consideration.

**_ SKILLS and LEADERSHIP CAPABILITIES_

**Experience and Education**:

- Extensive medical experience, Medical degree.

- Advanced degree in management, such as M. B. A. , M. P. H.

or M. H. A.

is an advantage.

- Experience working in a team environment and in a supervisory position managing direct reports.

- Experience of pharmaceutical industry particularly within the Oncology space will be preferred

**Critical Skills and Competencies**:

- Compliance insights: Profound understanding of compliance and medical Ethics, ability to navigate complex situations balancing SOPs, regulations, our values and business interests

- Business acumen coupled with drive for results, holding self and others accountable for commitments that align with our short

- and long-term goals.

- Customer centricity: Ability to understand the customers' needs, leading complex collaborations successfully and creating genuine win-win solutions.

- Knowledge of healthcare systems, medical quality assurance, quality improvement, risk management.

- Strong project management skills: ability to manage multiple projects simultaneously.

- Demonstrated Leadership skills to develop strategies and plans including:

- Collaborative leadership: Advanced communication skills to build and shape team and external relationships (with KOLs, policy makers, health economists, scientific societies, etc.

).

- Strong verbal and written communication skills, including presentation, influencing and negotiating skills and medical and scientific wr