Philogen - innovating targeting

Siena
Zurich

Careers in Siena

We are building a leading biopharmaceutical firm targeting cancer and other angiogenesis associated diseases with innovative products. Our employees at Philogen are driven by integrity, teamwork, and innovation. We offer a positive and young working environment in an emerging company.

Please feel free to submit your CV by e-mail to: jobopportunities@philogen.it

Or by standard mail to:
Philogen S.p.A.
Loc. Bellaria, 35
53018 Sovicille (SI)
ITALY

Open positions

Clinical Data Manager for a six-month stage

Philogen S.p.A. is a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a special focus on angiogenesis related disorders.
Philogen S.p.A. is looking for a Clinical Data Manager for a six-month stage to support the development of the Clinical Department.

In particular the successful candidate will give support in the following activities:

providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions.
reviewing and contributing to the development of trial validation plan, to the preparation of protocols, CRF's and operations manuals related documents.

developing validation checks necessary to assure high quality and consistent data.
generating trial data listings and reports on the collected data.

The ideal candidate should have:

Excellent written, verbal and organizational skills.
Strong prioritization skills.
Ability to handle multiple projects and stressful situations.
Good knowledge of MS Excel and Office package in general.
Good skills in data analysis.

Preferred skills:

Knowledge of medical terminology with expertise in oncology preferred.
Knowledge of coding dictionaries (MedDRA, WHO drug).
Knowledge in programming SAS language.

We offer:
A contract and salary proportional to the experience (seniority) of the successful candidate.

Job location:
Siena – Italy

Interested candidates are asked to send a detailed Curriculum Vitae, including the title of the position in the subject line, together with the authorization to process the personal data under the Legislative Decree 196/2003 and the GDPR 679/2016 to the e-mail address: jobopportunities@philogen.it.

MEDICAL ADVISOR

Philogen S.p.A. is accepting applications for the position of MEDICAL ADVISOR for the development of clinical experimental activity. The successful candidate will have the responsibility for supporting the management of Philogen’s clinical trials in oncology and rheumatology.

In particular the successful candidate will be responsible for:
Collaborating with opinion-leaders and professional faculty to best design and implement clinical projects.
Providing support in designing and writing clinical portions of IND documentation including protocols, amendments, medical reports, safety and efficacy summaries, scientific rationales, interim and final reports.
Providing support in monitoring efficacy and safety trends by reviewing clinical data. Interacting with Principals Investigators and clinical site staff to advance the performance of clinical trials.
Interacting with regulatory agencies and clinical centres to support the Company’s development program.
Participating in Strategic Meetings.

The ideal candidate should have:
A degree in Medicine.
An excellent level of English, both written and spoken.
Good interpersonal skills
Ability to build trust and confidence in teams/departments
Ability to work independently.

We offer:
A contract and salary proportional to the experience of the successful candidate.

Job location:
Siena - Italy

Interested candidates are asked to send a detailed Curriculum Vitae, including the title of the position in the subject line, together with the authorization to process the personal data under the Legislative Decree 196/2003, to the e-mail address: jobopportunities@philogen.it.

Process & Computer System Validation Specialist (job description in Italian)

Philogen S.p.a. seleziona candidati per la posizione di Process & Computer System Validation Specialist. La risorsa, inserita nel reparto IT, si occuperà della convalida e manutenzione dei sistemi computerizzati aziendali (CS). Supporterà il Responsabile IT nei progetti di qualifica dei processi, nuova strumentazione e relativi Software, e del mantenimento del loro stato di qualifica garantendone la compliance alle norme GMP, gli standard di qualità stabiliti e le procedure interne. Inoltre, supporterà il Responsabile IT nella produzione di tutta la documentazione di convalida e della sua corretta gestione e archiviazione.

PRINCIPALI RESPONSABILITA’:
Occuparsi del mantenimento, attraverso una revisione periodica, di tutti gli status di convalida dei sistemi computerizzati. Convalida di Sistemi Computerizzati in ambito Life Science secondo le Best Practice di riferimento GxP e GAMP.
Adeguamento dei Sistemi Computerizzati in ambito Life Science alla normativa FDA 21 CFR part 11.

REQUISITI:
Formazione ed esperienza:
Formazione in discipline tecnico/scientifiche.
Esperienza di almeno due anni nell’ambito farmaceutico.
Esperienza in ambito di preparazione documentazione di qualifica ed esecuzione protocolli IQ, OQ, PQ.
E' gradita la conoscenza di tutte le fasi del ciclo di vita dei sistemi computerizzati, esperienza nelle qualifiche IQ/OQ/PQ ed aver maturato esperienza di Data Integrity e Best Practices GxP.
E' gradita la conoscenza di tutte le normative applicabili in campo medicale con specifiche conoscenze nell’ambito della normativa ISO, FDA, GAMP (Annex11 e CFR 21 parte 11).
Esperienza nel campo dell'automazione (componenti dell'infrastruttura, impostazioni di dominio, sistemi di virtualizzazione, capacità/competenze di programmazione e di gestione di database).
Ottima conoscenza del pacchetto Microsoft Office.

Conoscenze linguistiche:
Buona conoscenza della lingua inglese parlata e scritta

Completano il profilo:
Attitudine al lavoro di squadra in team multidisciplinari.
Capacità di relazione e comunicazione con interlocutori interni/esterni.
Proattività e Intraprendenza: per migliorare continuamente prodotti, servizi, processi e procedure di lavoro.
Capacità di lavorare per progetti e/o obiettivi.
Tenacia ed orientamento al risultato.
Problem solving: capacità di apertura a nuove idee e nuove prospettive.
Flessibilità: passione per l'innovazione in tutti i processi, alla continua ricerca di nuove idee sostenibili.
Predisposizione al sostegno della Sicurezza e della Qualità.
Forti doti analitiche.

OFFRIAMO:
Un contratto ed un inquadramento proporzionale all'esperienza del candidato prescelto.

SEDE DI LAVORO:
Siena - Italia

Interested candidates are to send a detailed Curriculum Vitae, including the title of the position in the subject line, together with the authorization to process the personal data under the Legislative Decree 196/2003, to the e-mail address: jobopportunities@philogen.it.

A NEW GRADUATE WITH A SCIENCE DEGREE AND FLUENT GERMAN

Philogen S.p.A. is looking for a new graduate with a science degree with fluent german for a six month stage in Clinical Department.
The candidate will join our Clinical Department team and will be involved in the activity of the company’s team of Clinical Monitors in association with a company Tutor.

In particular, s/he will give support in the following activities:
Dossier preparation and submission following international guidelines.
Management and evaluation of clinical data.
Monitoring of national and European centres involved in the clinical studies.
The ideal candidate should have:
A good scientific background.
A good level of German and English language, both written and spoken.
The ability to travel frequently.
A high level of attention to detail.
The ability to work independently.

Stage location:
Sovicille (SI)

Interested candidates are to send a detailed Curriculum Vitae, including the title of the position in the subject line, together with the authorization to process the personal data under the Legislative Decree 196/2003, to the e-mail address: jobopportunities@philogen.it.

CAREERS