Location
Siena (SI) | Italy
Job description
Job Title: SENIOR MEDICAL DIRECTOR
Location: Siena - Italy
Department: Clinical
SENIOR MEDICAL DIRECTOR
Philogen S.p.A. would like to hire a SENIOR MEDICAL DIRECTOR for providing medical oversight, expertise and leadership to ensure the strategy, development and implementation of clinical trials, collaborating with R&D department for the excellence in execution of clinical trials in the interest of patients. The resource will report directly to Philogen CMO and Deputy CMO.
In particular the successful candidate will:
- Provide support in developing strategic plans for the company’s product portfolio to ensure the success of development programs.
- Work cross-functionally, providing medical insights, to define, plan and implement Phase 1-3 clinical studies through clinical proof of concept to support the development of new compound and new indications.
- Ensure compliance in all medical activities as per Philogen’s SOPs and local regulations.
- Develop and mantain scientific 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 including processes to address product issues, recalls and product complaints.
- 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 and reputationin the marketplace.
- Collaborate with opinion-leaders and professional faculty to best design and implement projects.
- Ensure drug safety and surveillance activities are consistent with established regulations and internal SOPs to meet or exceed safety objectives.
- Provide support in monitoring efficacy trends by reviewing clinical data (i.e. evaluation of inclusion criteria and protocol deviations).
- Interact with regulatory agencies and clinical centers in order to support the Company’s development program.
- Participate in Strategy Meetings.
- Provides medical expertise in all regulatory, early access and reimbursement approval processes. Ensure content and quality of the Clinical Part of the Submission Dossier.
- Attend and present materials, as needed, at meetings with Company as well as extra-company meetings.
- Prepare and present scientific articles and posters at international conferences.
The ideal candidate should have:
- A minimum of 5 years’ experience in a similar position in a Pharmaceutical Company.
- M.D. degree, preferably with additional Oncology track-record.
- An excellent level of English, both written and spoken.
- Ability to build trust and confidence in teams/departments
- 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.
We offer:
A contract and salary proportional to the experience (seniority) of the successful candidate.
Job location:
Siena
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address [email protected], 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).
Job tags
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