Communication Manager
(100% - permanent contract)
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Communication team based in Lausanne we are looking for a
Communication Manager
(100% - permanent contract)
Mission:
The Communication Manager will work cross-functionally with Marketing, Clinical Development, Translational Medicine and all key internal stakeholders to generate and execute a strategic communication plan consistent with the overall Company strategy and business needs. He/she will manage the flow of scientific/medical information related to Debiopharm pipeline of commercial and investigational products to create communication tactics and materials that resonate with key audiences including patients, physicians and business partners. He/she will proactively identify relevant communication opportunities within the group and use the right channels to support the development of the Debiopharm brand. He/she will provide input on field-based promotional materials and will provide support for the organization of key scientific congresses and internal educational conferences.
Your main responsibilities
- Establishes the multi-channel communication plan and strategy for Debiopharm International and its pipeline of commercial and investigational products.
- Drives the communication projects by collaborating with internal stakeholders, and makes sure that appropriate content is delivered timely to meet department and company objectives.
- Ensures consistency of scientific and medical messaging across communication materials.
- Uses relevant scientific and clinical data including competitors and identifies appropriate communication channels and formats.
- Creates and shares convincing materials supporting scientific evidence related to Debiopharm products.
- Ensures that scientific materials meet established internal and external (e.g. regulatory, best practice) standards.
- Provides input on the development of slide decks and other marketing tools utilized by externally facing functions.
- Creates and maintains a cycle of internal educational conferences.
- Participates in the development and maintenance of electronic platforms to facilitate broad access to Scientific Communications documents by internal and external stakeholders.
- Maintains resources on platforms for the dissemination and sharing of all relevant Scientific Communications documentation to support internal teams and stakeholders.
Your profile
- Life Science or Pharmacy degree or equivalent and additional certification in External Communication.
- 8 years' experience in multi-channel communication with a communication agency or within the Pharma industry with a focus on prescription drugs. Demonstrated ability to accurately and effectively exploit medical/scientific data.
- Proven track record in designing and implementing a multi-channel scientific communication strategy.
- Experience in Scientific Communications operational management.
- In-depth understanding of legal requirements, regulatory issues, and guidelines in the provision of Scientific Communication services.
- Knowledgeable in both on-line and off-line communication channels
- Excellent written and verbal communication skills, fluent in English and French
- Customer oriented with a pro-active and can-do attitude.
- Computer literacy.
- Strong time management skills, ability to be self-sufficient and resourceful.
- Excellent analytical problem solving and decision making skills.
- Ideally with in-depth understanding and up-to-date knowledge of developments and issues currently affecting global Scientific Communications role.
- Demonstrated ability to effectively present information to senior management, employees at all levels of the organization and to external audiences.
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application
R&D Financial Controller
(100% - permanent contract)
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Controlling team based in Lausanne we are looking for an
R&D Financial Controller
(100% - permanent contract)
Mission:
Within the Finance & Administration department, the mission of Controlling is to provide our top management with detailed financial analysis, scenario & reporting to support decisions making and help reaching the company's objectives.
You are responsible for all financial controlling activities within drug development throughout the full life of the project, from in licensing activities, development up to business valuation. Being a key partner and contributor across a highly matrixed, cross-functional project community, you support the R&D activities by shaping and owning reporting processes. You participate in the acquisitions and licensing activities by representing Finance for projects valuations.
Your main responsibilities
- Lead the R&D financial planning and reporting : work closely with PMO by providing proactive support on budgeting and forecasting processes, costs monitoring, quarterly closing and reporting, as well as act as a finance business partner on R&D activities.
- Own and deliver quarterly financial reporting to Project teams and Top Management.
- Provide financial & reporting expertise to the R&D teams, support and challenge them to implement efficiency initiatives.
- Pro-actively enhance the reporting processes and tools to enable a more effective decision making on development activities.
- Develop specific financial reports for grants requirements
- Collaborate with Business and PMO on projects valuation simulations using rNPV tools, ensure alignment with objectives of all stakeholders and track the value creation vs target.
- Own the R&D reporting module of our ERP.
- Management of outsourcing KPIs.
- Deliver support to the Controlling Services on various tasks.
Your profile
Being an excellent communicator is essential for the success in this role, including communicating numbers and data to non-financial people. You are motivated by working in a fast-paced environment and by discovering new ways to optimize processes and tools?
You also bring the following skills and experience:
- Master's Degree in Finance, Economics or similar
- Min. 5 years of experience working with project controlling in the pharma industry
- Solid expertise in developing financial processes in budgeting, forecasting and long-term planning, driving alignment across multiple functions
- Experience building and coordinating project valuations scenarios
- Excellent analytical, communication and presentation skills
- Used to daily work with an ERP, MS Office Excel super user, MS Project is a plus
- Fluency in English and French
- Ability to manage complexity and deliver high quality results under time constraints
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please go to this page to send your application
If you fit this profile please send your application
MEDICAL DIRECTOR, CLINICAL PHARMACOLOGY
(100% - permanent contract)
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Pharmacology & Drug Metabolism team in the Translational Medicine department based in Lausanne we are looking for a:
MEDICAL DIRECTOR, CLINICAL PHARMACOLOGY
(100% - permanent contract)
In this role, you will be responsible for the clinical pharmacology program of Debiopharm's projects, leveraging state-of-the-art PK and PK/PD methodologies. You will lead the clinical strategy and deployment of the early phases in healthy volunteers.
Your main responsibilities:
- Responsible for the scientific/medical/technical aspects of assigned healthy volunteers clinical pharmacology studies from conception through final report, including first-in-human studies (SAD, MAD), clinical drug-drug interaction, TQT, special populations PK and ADME studies; provides also his/her medical expertise for clinical pharmacology aspects of oncology projects.
- In collaboration with Clinical Operations and Program Medical Director when applicable, conduct and monitor drug safety in early clinical phases and in late clinical pharmacology studies in healthy volunteers.
- Collaborates with Clinicians, Biostatisticians, Translational Medicine, Clinical Operations and Regulatory functions to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
- Develop, in collaboration with the relevant functions within Translational Medicine and Clinical Research & Development, the methodology for safety monitoring in clinical trials.
- Determine, in collaboration with the relevant functions within Translational Medicine, clinical dose selection and dose adjustment.
- Be a member of the project team and work in a collaborative and proactive way in a matrix environment.
- Responsible for authoring and reviewing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.
- Responsible for identifying, overseeing and managing external vendors and consultants supporting the clinical pharmacology function.
- Liaises with KOLs and academic collaborators on state of the art clinical pharmacology science and methodology.
- Identifies and communicates potential project hurdles, suggests solutions and establishes priorities and contingency plans,
- Ensures the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
Your profile:
- M.D., with focus in clinical pharmacology, pharmacokinetics, or a related field,
- At least 5-8 years of direct experience in Biotech/Pharmaceutical industry,
- Proven track-record in early clinical phases of drug development, clinical pharmacology, clinical research concepts and practices, PD and clinical PK and/or contribution to drug development programs that resulted in one or more marketed drugs,
- Expertise in hepatic and cardiac safety management,
- Hands-on experience in authoring regulatory documentation and experience in attending regulatory meetings,
- Experience with PK and PK/PD data analysis would be an advantage,
- Experience in antibacterial or anti-infective drug development and/or in clinical pharmacology programs of oncology drugs is considered a plus,
- Excellent leadership, management, collaboration, communication and decision making skills.
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application
Principal Medical Writer
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacturing of drugs and diagnostic tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are marketed by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Research & Development department based in Lausanne we are looking for a:
Principal Medical Writer
This position involves the development of study-related documents, communication with health authorities, publications and presentations. The Principal Medical Writer (PMW) ensures compliance with international guidelines and internal quality standards and is accountable for the process of authoring, reviewing and reconciliation of comments (following internal and external reviews), and finalisation/approval of documents.
The PMW is responsible for timely delivery of well-written concise documents that are supported by data and suited to the target audience and intended purpose.
Main responsibilities:
Writing:
- Author documents such as protocols/amendments, informed consent forms (ICFs), clinical study reports (CSRs), Investigator's Brochures (IBs), briefing books, response documents, Paediatric Investigation Plans (PIPs). Manage review cycles, reconciliation of comments, and finalisation/approval of these documents.
- Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements.
Collaboration and Interactions:
- Develop effective collaborations with other line functions.
- Interact with Medical Directors in order to contribute to the strategy and understanding the clinical aspect of the writing and priorities.
- Interact with Clinical Scientists in order to better understand the rational and to be provided with the right background material and ad hoc drafts of specific documents sections.
- Interact with Regulatory Affairs.
- Responsible for a timely document development and negotiating timelines with the Project/Study Team and the Medical Director.
Leadership:
- Provide leadership in cross-functional communication / team meetings to optimize feedback and input towards focused and high quality documents.
- Challenge and resolve conflict during document development and finalisation
- Drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development).
Strategy:
- Develop the strategy for document preparation and the document review processes. Collaborate closely with the teams in order to better understand the needs, the planning, and timelines. Facilitate document review meetings and discussions.
Resource Management:
- Participate in resource planning for medical writing deliverables.
- Prioritize and manage multiple demands and projects with respect to deadlines.
- Collaborate with freelance and vendor medical writers and working across functional boundaries.
Quality:
- Understand and implement the applicable international quality standards (ICH GCP) and company procedures.
- Provide expert advice in the development and implementation of best practices in medical writing.
Your profile:
- Minimum university life science degree or equivalent is required. Master's degree in a scientific area is preferred.
- 7 years medical writing experience and/or other relevant pharma industry experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.
- Proven experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.
- Experience in early phase clinical development in Oncology.
- In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
- Good command of English and solid writing/editorial skills (understandable, at a level appropriate to the audience and the project).
- Strong ability to prioritize and manage multiple demands and projects with respect to deadlines.
- Ability to communicate scientific or medical information in a clear and concise manner.
- Ability to interpret data, identify any limitations.
- Self-starter, flexible, able to adapt quickly in a fast-moving environment, work efficiently within the given time and resources.
- Ability to work with teams, establish trust, challenge appropriately and focus on results.
- Ability to lead and influence.
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application
