MEDICAL MANAGER HEMATOLOGY Job in International, Lombardia Italy

Il nostro cliente: Our client is an international pharmaceutical company. We are currently assisting them in recruiting a:

Descrizione: This position is in the Oncology Region Europe (ORE) Business Unit. The Hematology Medical Manager / Senior Clinical Research Manager will work directly with and report to the Region Europe Medical Director Haematology in developing and implementing strategic clinical projects for GLIVEC, panobinostat and PKC. He/she will lead the

planning, execution and reporting of the regional Medical Affairs program on time, within budget and in compliance with processes and regulatory requirements, liaising closely with relevant leading investigators and with Global and European MA functions.

1. Define and drive the clinical plan (aligned with the global C4 plan and in-line with RE strategic objectives) in collaboration with the RE clinical trial team (CTT), and European leading investigators.

2. Identify and develop potential life cycle management opportunities.

3. Generation of key data through registries, non-registration trials; health outcomes research and analytics.

4. Develop and maintain relationships with key opinion leaders.

5. For Regional trials:

- Responsible for the design/preparation of the study protocol and obtaining approval by the protocol review committee (PRC), in addition to preparing and submitting the study report and publication planning in collaboration with CTT members.

- Responsible for the execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment and data consistency).

- Responsible for project tracking

- Contribute to the preparation of clinical program documents (investigator

brochure, IND annual report, HA briefing books and submissions).

6. Provide support to BU medical advisors/medical affairs groups in the development of local studies, ensuring strategic alignment.

7. Contribute to multidisciplinary (medico-marketing) task forces to support continuous improvement, ensuring the appropriate execution of key medical activities (MPH, advisory boards, etc.)

8. Medical education

9. Coach regional interfunctional teams (marketing and medical) and countries MA members.

10. Participate in the eGPT; liase with the ICT, CTT and GBMD for participation of the assigned region in development trials (including leading the pre-allocation process.)

Profilo ricercato: The appropriate candidate will be a MD, preferably with experience in Hematology/Oncology, or PhD with comparable experience.

Experience in the pharmaceutical industry in MA and/or research and development is desirable, though not required.

Medical/scientific writing experience, ability to critical-ly review and interpret data, strong oral and written communications skills, strong leadership skills and ability to function in an interdisciplinary team are es-sential.

1. Minimum 5 years experience in drug development. Clinical experience preferred.

2. Knowledge of clinical trial design, statistics and pharmacokinetics.

3. Strong ability in project management and problem-solving

4. Proven ability to write Clinical Study Protocols, reports and publications.

5. Ability to interpret safety and efficacy data.

6. Familiar with all aspects of the clinical development process.

7. Knowledge of the medical, scientific and clinical research techniques of the assigned area.

8. Knowledge of GCP and regulatory requirements.

9. Ability to lead and work in teams and coach team members.

10. Strong ability to work in matrix environments

Fluent English (oral and written).