CAREERS

Philogen would like to hire a Regulatory Affairs Associate. The role will report to the Regulatory Affairs Manager. This position will collaborate with other functions in the Clinical Department.
 
In particular, the selected candidate will carry out the following tasks:

• contributing to the preparation of documents for, e.g., submissions of initial clinical trial applications, amendments, notifications, communications and replies to requests from regulatory agencies;
• gathering, evaluating, organizing information necessary for regulatory agencies and other third parties;
• updating relevant clinical documents such as patient information cards and informed consent forms in compliance with the master reference documents;
• managing preparation and shipment of final documents for submission;
• supporting in negotiating with regulatory authorities;
• ensuring that quality standards are met and submissions meet deadlines;
• performing the registration, update and posting of results of Philogen studies in mandatory clinical trials and publication databases;
• managing the update of the Trial Master File and archiving of the documentation regarding the Competent Authorities and Ethics Committees of all Philogen studies in collaboration with the CTA;
• preparing and revise controlled documents including clinical Forms, Templates and Standard Operating Procedure (SOPs) referred to the Regulatory Affairs;
• training clinical staff in regulatory policies or procedures;
• keeping up-to-date with changes in regulatory legislation and guidelines and evaluating applicable laws and regulations to determine impact on department activities;

  Requirements:

• Has a degree in a Life Sciences discipline.
• Previous experience in a similar role.
• Excellent written and oral communication skills.
• An excellent level of English, both written and spoken.

 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
Sovicille (Siena) - Italy
 
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 
 
 

Philogen S.p.A. is looking for a “Clinical Quality Assurance Senior Specialist (GCP)” who will report to the GCP Quality Assurance Manager. The position will be responsible to assess compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols. This position will collaborate with other functions in the Clinical Department.
 
In particular the successful candidate will be responsible for:
Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted in Europe and US.
Review and/or Approval of clinical SOPs and support continuous process improvements
Perform Quality reviews of clinical trial protocols and associated documentation (including informed Consent Documents, CRFs, etc.) as appropriate.
Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures as well as regulatory guidelines.
Report significant clinical quality deficiencies and/or risks to QA management and actively participate in solving the issues.
Perform GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
Lead preparation of the company and clinical sites for customer audits and regulatory GCP inspections. Participate as Subject Matter Expert during regulatory GCP inspections
Manage training of staff on company procedures, GCP regulations, and documentation systems.
 
The ideal candidate should have:
A good scientific background (ideally Master/ PhD in Biology, Biotechnology, etc.)
Ideally 3-5 years of experience in Clinical Quality oversight (QA experience in the Pharmaceutical industry required).
A complete understanding and application of principles, concepts and practices of clinical research procedures is required.
A high level of English language, both written and spoken;
A high level of attention to detail;
The ability to work independently, to prioritize her/his own work as well as to prioritize task and coordinate other team members;
Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges.
 
Job location:
Sovicille (Siena) - Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 

Philogen S.p.A. would like to hire a GMP Production Manager who will report to the Plant Manager. This role will be liaising closely with the other departments.
 
In particular the successful candidate will be responsible for:
Developing, optimizing and delivering upstream/downstream fermentation whilst remaining fully GMP compliant.
Keeping the efficiency of his department, premises and equipment, taking care of the maintenance of the production facility and equipment.
Working closely with Quality and Validation to ensure operational and regulatory compliance
Designing and delivering analytical processes to validate the fermentation performance metrics
Coordinating a team of production operators Ensures the training of staff in your department.
 
 
The ideal candidate should have:                                                                                     
-       Excellent GMP experience, with previous mammalian cells fermentation experience in industry A minimum of 5 years’ experience in a similar position in a Pharmaceutical Company.
–      An excellent level of English, both written and spoken.
–      Excellent interpersonal, managerial and organizational skills.
–      A Degree in Biology, Biotechnology or Chemistry.
 
Job location:
 
Sovicille (Siena) - Italy
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 

SENIOR REGULATORY AFFAIRS MANAGER
 
Philogen is a Swiss-Italian integrated biotechnology company founded in 1996, with the mission to develop innovative biopharmaceuticals for the treatment of angiogenesis-related disorders.
Philogen would like to hire a Senior Regulatory Affairs Manager responsible for providing strategic regulatory intelligence, guidance and regulatory expertise for product development from clinical through registration and product optimization.
 
In particular, the successful candidate will be responsible for:

• Manage US / EU submissions such as new marketing authorization applications, lifecycle management activities and responses to Health Authority questions.
• Author high-quality documentation and/or review documentation CTD sections, IMPD, BLA, etc. for Health Authority submissions (CTA, MA, etc.).
• Formulate and lead global regulatory strategy for assigned development projects maximizing the business benefit balanced with regulatory compliance.
• Maintaining knowledge up to date of all current applicable regulations and proactively participating in the design of global regulatory strategies.
• Making sure that all necessary documentation is completed and submitted in compliance with applicable government regulations.
• Acting as the liaison with other Philogen divisions keeping each department informed of applicable regulations and monitoring compliance.
• Acting as the liaison between Philogen and the Regulatory Authorities on CMC related topics. Leading preparation of meetings with regulatory agencies as needed and ensure regulatory issues impacting global regulatory strategy for proposed marketing filings are considered.
• Assist during regulatory agency inspections.

Requirements:

• Degree in a Life Sciences discipline.
• Previous experience as a Regulatory Affairs manager, ideally with significant experience in the regulatory submission and approval processes for new medicinal products.
• Effective verbal and written communication skills in order to keep other managers and department heads informed of regulations and policies that require compliance.
• Problem solving and strategic planning skills.
• An excellent level of English, both written and spoken, to enable the correct completion of reports and documentation required by regulatory authorities.
• Good interpersonal skills and able to work effectively both in cross-functional teams and independently.
• Attention to detail, and capacity to follow projects through to completion.  
• Experience with CMC regulations for parenteral drug products.

 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
Sovicille (Siena) - Italy
 
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 

QUALITY CONTROL MANAGER
Philogen S.p.A. would like to hire a Quality Control Manager who will report directly to the Plant Manager.
 
In particular the successful candidate will be Responsible for:

• Biochemical, Microbiological and Viral QC laboratory functions and the corresponding documentation to support the timely disposition of product.
• Overall Quality control disposition of incoming materials and finished products.
• Analytical method set-up and writing reports.
• Reviewing and approval of the entire SOPs relating to Quality control tasks and ensuring understanding and implementation of these SOPs.
• Insuring compliance of laboratory procedures and practices with Philogen Quality standards and with GMP and GLP regulations.
• Supporting laboratory colleagues in all aspects of their work to achieve the completion of tests and/or investigations in a timely manner as well as maintaining an updated knowledge base in the technical, operations, company policy and regulatory fields.
• Management of site products stability studies.
• Facilitating continuous improvement in QC day to day operations and general systems and will actively support achievement of plant goals.
• Coaching and developing QC colleagues to achieving high performance.

 
The ideal candidate should have:

• A good scientific background.
• People management experience.
• Comprehensive knowledge of GMP.
• Minimum 5 years’ experience in Quality Control management in pharmaceutical industry field.
• Knowledge of the following analytical techniques: E.L.I.S.A immunoassays, SDS-PAGE Electrophoresis, Size Exclusion Chromatography/ Cation Exchange by HPLC, Bacterial Endotoxins determinations, cells proliferation assay, cell culture, real time PCR.
• High analytical skills.
• Communication & high interpersonal skills.
• Problem solving skills.
• A high level of attention to detail and the ability to prioritize working tasks.
• Good English knowledge.

 
We offer:

•  A dynamic environment.
• A permanent contract with a salary proportional to the experience level of the successful candidate.

Job location:
Sovicille (Siena) - Italy
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Philogen S.p.A. is looking for a “GMP Quality Assurance Specialist” who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen’s Quality System.
 
In particular the successful candidate will be responsible for:

• writing, reviewing and approving documents (SOPs, PQRs, IMPDs, validations, research reports, etc.);
• revision of production and quality control batch records;
• managing GMP QA operations, change control, deviation and documentation systems;
• identifying and recommending future improvements;
• implementing action plans;
• developing quality strategies and priorities and translating them into short and long-term objectives;
• risk assessment;
• interacting with other members of the company and clinical center staff.

 
The ideal candidate should have:

• A good scientific background (ideally in Biology, Biotechnology, etc.)
• Previous experience in Quality Assurance (at least three years);
• Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development, submission and clinical experimentation;
• A high level of English language, both written and spoken;
• A high level of attention to detail and with the ability to prioritize working tasks;
• A strong flexibility in changing tasks and priorities;
• The ability to work independently as well as coordinate members of his/her team;
• Excellent interpersonal skills and ability to work in teams.

 
Job location:
Monteriggioni (Siena) - Italy
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 

BIOSTATISTICIAN
 
Philogen S.p.A. would like to hire a BIOSTATISTICIAN to support our Clinical Department.
 
 
Responsibilities:
Develop study design and data analysis plans.
Execute statistical analyses for clinical trials (e.g. sample size calculation, interim analysis design, PK  analyses, etc.)
Write the statistical analysis plans and produce statistical reports related to trial execution
Provide statistical expertise in analysing and modelling clinical data.
Analyse, evaluate, and report on complex observations related to clinical data.
Provide active support in producing data listings and summaries.
Good experience with statistical software packages such as R and SAS.
Excellent written communication skills.
 
 
Requirements:
A graduate degree in biostatistics or mathematics.
Strong mathematical and statistics skills
Problem solving
Flexible attitude to work on different tasks
Written and oral communications skills
Strong teamwork skills
Critical thinking
Solid knowledge of R and SAS
Strong computer background (it represents a plus the knowledge of additional programming languages)
 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
Siena - Italy

 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

 

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 kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Philogen S.p.A. would like to hire a CHIEF MEDICAL OFFICER for providing medical oversight, expertise and leadership to ensure the strategy, development and implementation of clinical trials, supporting the R&D department in planning product availability for clinical studies.

In particular the successful candidate will be responsible for:

• Provide support in developing strategic plans for the company's product portfolio to ensure development programs.
• Advocate for the health and well-being of our patients.
• Work cross-functionally to define, plan and implement Phase 1-3 clinical studies through clinical proof of concept.
• Develop relations with leading physicians to consult on various topics including Clinical Advisory Boards.
• Develop processes and procedures to ensure the safety and monitoring of our products
• Manage medical/clinical supervision/oversight of individual clinical trials.
• Provide medical input into complaint and adverse event investigations.
• Interface with physicians and/or patients related to medical inquiries associated with our products.
• Support the business development resource to increase the Company’s position in the marketplace.
• Collaborate with opinion-leaders and professional faculty to best design and implement projects.
• Design and write clinical portions of clinical documentations (e.g. protocols, amendments, medical reports, etc.)
• Interact with regulatory agencies and clinical centers in order to support the Company’s development program.
• Participate in Strategy Meetings.
• Appropriately represent Philogen when building and maintaining relationships with partners; ability to build trust and confidence in teams/departments.

The ideal candidate should have:

• A degree in Medicine (mandatory requirement)
• A minimum of 5 years’ experience in a similar position in a Pharmaceutical Company.
• An excellent level of English, both written and spoken.
• Excellent interpersonal, managerial and organizational skills.
• Excellent writing and presentation skills.
• Ability to complete tasks independently and efficiently with attention to detail and in a timely manner.

Job location:
Siena - Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).