Life Science

Medical Director Drug Development-Oncology

My client is a growing international pharmaceutical company based in the French part of Switzerland with ongoing growth.

Due to this growth, my client is looking for a Medical Director Drug Development to provide leadership and establishing strategy and implementing clinical drug efforts for oncology product Phase I to III.

 

Responsibilities

 

  • Lead oncology drug development for successful implementation and conduct of clinical trials including early phase investigations and registration trials
  • Provide medical and scientific leadership for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilance and study delivery
  • Interact with global regulatory bodies including the FDA and EMA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and New Drug Applications (NDAs).
  • Facilitate the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, CRFs, CSR, meeting abstracts and scientific journal publications
  • Collaborate with external vendors such as CROs, external imaging and laboratory resources, as well as global pharmaceutical companies for successful implementation and conduct of early phase and registration global clinical studies
  • Serve as a source for medical and scientific expertise in oncology for outlining design strategy and execution for anti-cancer drug development
  • Liaise with discovery science to facilitate and further the development of investigational agents from a preclinical stage to clinical development
  • Represents the company at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders
  • Detect and analyzes emergent issues during clinical drug development and develops and implements mitigating strategies
  • Works in partnership with medical affairs for successful launch of future antineoplastic agents
  • Provide guidance for successful implementation and accomplishment of investigator initiated trials related to product development and life cycle management of a compound

 

 

Your profile :

 

  • MD. degree
  • At least 3 – 5 years of industry experience in oncology drug development
  • Experience in leadership and establishing strategy and implementing clinical drug efforts for oncology products
  • Strong interpersonal, verbal and written communication skills.
  • Oral and written proficiency in English

Please send your application to noliva@axepta.com 

Senior Clinical Research Scientist-Oncology

My client is a growing international pharmaceutical company based in the French part of Switzerland with ongoing growth.

Due to this growth, my client is looking for a Senior Clinical Research Scientist to work with the physicians and other members of the Clinical Team to provide clinical research support for programs in Oncology.

 

Responsibilities :

 

  • Development of protocols for clinical studies
  • Preparation of clinical development plans
  • Drafting of clinical scientific documents such as IND, IND amendments Investigator Brochures, Annual Reports and other FDA submissions
  • Monitor, review and summarize safety and efficacy data in ongoing studies
  • Assist with study design for exploratory development
  • Will lead the clinical matrix teams for assigned compounds
  • Develop relationships with appropriate consultants
  • Write abstracts and present data at scientific meetings, both internally and externally
  • Serve as liaison to project teams, CRO’s and others

 

Your profile:

 

  • Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred
  • Minimum of 4 to 6 years of experience in research with at least 3 or more years of drug development experience are preferred
  • Prior Oncology/ Haematology Drug Development experience
  • Ability to multi-task and work in a fast-paced environment
  • Excellent written and oral communication skills
  • Strong Analytical ability
  • Oral and Written proficiency in English

Please send your application to noliva@axepta.com

Head of Bioanalysis

Our client is a CRO located in the South of France. Due to his growth, he is looking for a Head of Bioanalysis

 

YOUR RESPONSIBILITES

 

  • Support starting up the bioanalytical laboratory. Train and coach principal investigor(s) in regulated bioanalysis in order to facilitate successful GLP inspection
  • Support the team and the Study Director
  • Moderate the change management in the bioanalytical laboratory in the transition process from an internal R&D laboratory to a CRO
  • Transfer existing standard operating procedures into the site SOP management system; support harmonizing procedures where needed and implement already harmonized the company procedures Implement method development and validation guide.
  • Mentor and coach principal investigator(s)/project manager(s) to increase level of professionalism and give them deeper insight in Sponsor’s expectations.
  • Leverage experience in state-of-the-art LIMS during the implementation process of Watson LIMS at company on a global scale
  • Act as (deputy) project manager mainly during absence of principal investigator(s)/project manager(s)

 

YOUR QUALIFICATIONS

 

  • Master degree in chemistry, specialized in analytical chemistry and biochemistry.
  • At least 15 years of experience in Bioanalyses
  • Experience in Pharmaceutical industry and working with CROs
  • Experience in Project Management and leading study teams
  • Knowledge of bioanalytical methods (LC-MS/MS, HPLC-UV/FD, etc.)
  • Experience in managing and guiding teams as Project Manager
  • High social competence and enjoyment in dealing with complex projects
  • Independent and structured working method with hands-on mentality
  • Very good communication skills in English are required

 

 

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International Senior Clinical Project Manager

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton.

Due to this growth my client is looking for an International Senior Clinical Project Manager with strong experience in global clinical trial management.

 

Responsibilities:

 

  • Responsible for leading and managing the multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
  • Responsible for the development of the Clinical Trial Outline (CTO) and Clinical Protocol.
  • Ability to manage complex phase III clinical trial programs.
  • Manages selection of study vendors for assigned studies.
  • Manages vendor(s) throughout the life of assigned clinical trial(s).
  • Selects investigational sites with input from Clinical Development and vendors.
  • Reviews and refines Clinical Operations Plans including monitoring and other plans.
  • Works with operations to oversees investigative sites’ adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs.
  • Provide input and contribute to the other study related documents.
  • Plans and conducts investigator meetings, training sessions and KOL meetings as required.
  • Review clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels.
  • Works with CS, ME and project team as appropriate to develop the Clinical Study Report.
  • Identifies and provides solutions to clinical trial issues or risk.
  • Provide input together with the Clinical Project Team on responses to Health Authority questions and/or Ethic Committee/IRB.
  • Mentors staff and serves as a resource for new employees.
  • Provides or facilitate training to clinical study teams on protocol specific topics.
  • Participates as appropriate in internal and external audits.
  • Manages communication of study status and guidance to internal stakeholders.
  • Manage subcontractors (CROs, experts …):
  • Milestones and establish budget and timelines for the study conduct together with the study team. Establish a detailed planning of clinical project.
  • Build, follow-up and close out study Budget following internal templates and instructions and according to the initially approved budget.
  • Track all aspects of the Clinical Trial and make regular progress reports.

Your profile :

  • University degree, preferably in a biologic/scientific discipline
  • Minimum of 10 years experience in clinical operations including 5 years of clinical project management or equivalent with Pharma/Biotech and/or CRO
  • Experience working on phase II and III at international level
  • Ability to travel 30%

 

For more information please send your profile to noliva@axepta.com

In-Vitro Biology Expert

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for an In-Vitro Biology Expert with strong experience in cosmetic development to join their growing strategic innovation group.

 

Responsibilities:

 

  • Manage all outsourced activities related to human skin cell culture models and tissue engineering
  • Identify and validate complex in vitro human skin cell culture models or tissue engineering that reflect key features of healthy and disease states of skin and which can be applied to new bio-markers discovery and mechanisms of action studies in dermatology
  • Validation of in-vitro claims
  • Screen biological properties of new active ingredients (in vitro/ex-vivo models)
  • Find alternative models in vitro et ex-vivo to answer projects needs
  • Propose scientific insights to support innovative scientific communication & claims: new technical models/models
  • Contribute and propose alternatives to develop claims with added value in the overall strategy of brands
  • Build on consumer focus and technical expertise, propose the development of novel methods/models (in vitro, ex-vivo) as well as novel technologies/actives
  • Pilot and manage, all in-vitro studies and those of novel design ensuring their execution to high scientific quality within the specified time frame and to high scientific standards
  • Review all data related to the outsourced scientific activities, interpret results and synthetize the results for project teams
  • Review scientific literature to maintain current knowledge on technical, scientific and regulatory developments in respects to in vitro metabolism
  • Propose and write patents and publications as needed

 

Your profile:

  • Minimum 7-10 years experience in cosmetic Development of industry with a background in Cell Biology, Bioengineering, or a related life science discipline in dermatology
  • Solid experience in managing projects
  • Knowledge of GLP
  • Strong understanding of skin metabolism
  • Able to work consistently to high standards, meeting deadlines and able to work with changing priorities
  • Direct experience using conventional and/or complex in vitro skin tissue culture models, including with primary human skin cell cultures, co-culture systems, 3D reconstituted human epidermis, and human skin organ cultures
  • Ability to independently design, supervise and analyze experiments with outsourced partners using molecular, cellular, and biochemical techniques with a focus on skin biology and tissue engineering applications
  • Strong understanding of cosmetic development process, skin knowledge and stakeholders network influencing Consumer care business
  • Proficiency in English
  • Strong communication skills

 

Please send your profile to noliva@axepta.com 

Head of Medical Training and Education

My client is an innovating, dynamic and growing international pharmaceutical company based in French part of Switzerland, Vaud Canton.
Due to this growth my client is looking for a Head of Medical Training and Education with a pharmaceutical experience.
Responsibilities:
• Member of Corporate Medical Affairs Department, working closely with Global Medical Leads, Marketing teams, PV, HR, Corporate communication as well as affiliates
• In addition, will work closely with external partners involved in various outsourced projects.
• Responsible for the creation and maintenance of the medical compendium, aimed at providing all medical internal stakeholders with consolidated and validated medical information on the comany’s prescription products at global and local levels of the company
• Medical compendium includes Medical information request (Medical Q&A) management and guaranty of the required interface with Pharmacovigilance department
• Responsible for the creation and development of a medical academy aimed at defining and executing the medical internal training strategy for medical affairs and Field force, providing trainers with adapted and updated training material, assessing trainers and Medical Science Liaison, in partnership with Professional relation unit.
• Planning, production and roll-out of educational tools for external targets.
• Recommend Global Learning and Development team on medical topics training for all company employees.
Your profile:
• Scientific degree (Pharmacist, Chemist, Biologist…)
• Pharma experience. A previous professional experience in education or training in a scientific or medical structure would be an asset.

 

Please send your CV to noliva@axepta.com 

Head of Medical Professional Relations and Patient Advocacy

My client is an innovating, dynamic and growing international pharmaceutical company based in French part of Switzerland, Canton of Vaud.

Due to this new dynamic, my client is looking for a Head of Medical Professional Relations and Patient Advocacy to oversee the company’s relationships with the medical community and patient organizations.

Responsibilities:

• Build state of the art EE Profiling and Mapping capabilities allowing efficient EE selection.
• Support EE engagement with a broader base of EEs to avoid overusing specific EEs
• Monitor and report relationships with existing EE through CRM system.
• Review and select CRM software/provider that meets the company’s needs globally
• Build relationships with global medical thought leaders leading medical societies.
• Design and deliver strategic advocacy initiatives, in alignment with local activities and Global strategy.
• Support TA Global Medical Affairs’ external engagement strategy
• Lead the development of Medical Education program agendas for CME events
• Represent the company at selected key congresses and professional meetings
• Develop strong collaborations with patient advocacy groups that work in disease areas of interest
• Be point of contact for internal Patient Centricity projects
• Lead the introduction and establishment of a Patient Centricity mindset and strategy
• Develop and maintain the company’s Patient Centricity Charter
• Lead the creation of digital content (social media posts, photos, videos other creative materials)
• Align with governance structure for review and approval of digital/social media content (ex. Global Social Media policy, PRC Review)
• Oversee key analytics tools/partners and make recommendations for improvement.
• Lead Global Funding Request Strategy and chair its Committee
• Collect and Prioritize Global Funding Requests based on alignment with global Compagny’s strategy
• Budget and forecast accuracy within GFR centralized budget
• Serve as single point person and project lead for all Global Funding Requests; receive and review requests for completeness; prepare for, lead and coordinate all GFR Committee meetings; and communicate with grant requestors.
• Communicate internally which organizations that receive funding from the Compagnie’s GFR Committee, the strategic interest and the outcomes and progress updates
• Align GFR practices with Global and Local compliance regulations.
• Builds and manages a team of MPR Managers.
• Develops and implements appropriate SOPs and strategic initiatives to improve efficiencies related to MPR and cross-functional collaborations.
• Prepare unit budget request and control spends within the defined yearly budget

Your profile:
• PhD or Pharmaceutical Degree or equivalent
• 10 years of experience in pharmaceutical industry in an equivalent position

 

Quality Assurance Director-Biologics

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their quality team.

Due to this growth, my client is looking for a Quality Assurance Director to join their team on a permanent contract.

The incumbent will be responsible to lead and manage the Quality Assurance activities of the bio-manufacturing plant under cGMP regulations for clinical and commercial supply of biological API. Provides leadership, direction and oversight to the associated team.

Initially, this position will be responsible for the Quality Assurance oversight of the manufacturing activities during the design, construction and startup of a new green-field, large scale manufacturing facility.

Responsibilities will include supporting the qualification and validation during the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment utilized in the production of biopharmaceutical drug substance according to quality policies, cGMP, EU / US FDA Regulations.

Responsibilities :

  • Work with the Engineering company in detail design deliverables
  • Understand and implement internal policies, procedures and specifications as required for the execution of quality compliance for the project
  • Define the strategy for review and approval of qualification, validation and engineering documents (ie test protocols, CAPAs, deviations, change controls, technical documentation)
  • Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management
  • Lead and manage a team in the quality compliance area
  • Ensure that all SOPs are in place for facilities and equipment qualification / validation
  • Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams
  • Act as the main point of contact for all quality compliance key topics
  • Prepare the site for regulatory inspections (Swissmedic and International)
  • Ensure that all licenses and registrations are kept current
  • Ensure all SOPs are in place and current
  • Compile and present plant Quality Metrics
  • Main point of contact with local and international Regulatory Agencies
  • Ensure all products are manufactured and released according to applicable regulations and registered details
  • Organize and lead quality improvement projects and teams
  • Contribute positively to a strong culture of business integrity and ethics
  • Act within compliance and legal requirements as well as within company guidelines

Requirements

  • Minimum of 6 years in a quality senior managerial role in a biopharmaceutical manufacturing environment
  • Strong knowledge of biotechnological technologies, processes and clean utilities
  • Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation
  • Ability to make pragmatic and compliant decisions
  • Strong result orientation, excellent team leader as well as committed team member
  • Flexibility and ability to travel
  • Excellent written and verbal communication skills.
  • Bachelor’s Degree in relevant Life sciences field
  • Must speak English and French

For more information please contact Noemie Oliva at noliva@axepta.com

 

Drug Design API Senior Manager

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Drug Design API Senior Manager to work with the Head of API Discovery and be responsible for the global activities of Design and Evaluation of future oral and topical drug candidate molecules.

 

Responsibilities

  • Recommends and contributes to the implementation of the Drug Design strategy of the Research for oral and topical projects.
  • Contributes to the evaluation and prioritization of projects in the Research portfolio.
  • Recommends the strategic outsourcing choices of Drug Design and evaluation activities and ensures the implementation of partnerships and technological solutions that best correspond to strategic choices.
  • Leads, organizes and contributes to the design and evaluation of innovative molecules for future drug candidates via CROs, for oral and topical projects in the portfolio
  • Ensures the implementation of technological solutions best suited to strategic choices.
  • Leads interaction with CRO partners for all design components of future drug candidates for portfolio projects.
  • Ensures the level of quality needed for a future clinical evaluation.
  • Contributes to maximizing the value proposition of Research and Development projects.
  • Participates in defining the future strategic axes of Research
  • Contributes to scouting, evaluation, licensing and / or internalization of molecules and / or projects in the different phases of Research and Development.
  • Contributes to the management of the global research budget

 

Your profile:

  • PhD in Organic Chemistry or PhD in Medicinal Chemistry.
  • Minimum 15 years of expertise in the trade of Drug Design.
  • Academic or experiential training in biology, pharmacokinetics, silico modelling techniques and drug discovery process
  • Academic or experiential training in multidisciplinary team management.
  • You have demonstrated an experience of innovation and significant achievement in the field of Drug Design as well as in the field of systemic, oral or injectable medicines.
  • Experience conducting collaborative research programs with external partners.
  • You have good knowledge of development processes and early clinical development in particular
  • Excellent teaching and presentation skills are expected, as well as an excellent leadership capacity with a multicultural and multidisciplinary team.
  • You speak and write English fluently.

 

In Vivo DMPK Lab Head-Germany

My client, a growing mid-size pharmaceutical services company is currently growing their activities therefore looking for a In Vivo DMPK Lab Head to join one of their office near Munich area (with home-based flexibility offered)

 

Responsibilities:

 

  • The incumbent will act as study director for in vivo DMPK studies and provide DMPK expertise to client pre-clinical development plans and supervise the in-house laboratory animal studies
  • Together with management you will develop the organization into a high quality and leading European pre-clinical DMPK service site.
  • Leading a non-clinical in vivo DMPK lab staffed with scientists
  • In the role of Study Director / Principal Investigator take responsibility for the design, planning, execution and reporting of non-radioactive and radioactive preclinical ADME and PK studies for small and large molecule, if necessary according to GLP standards
  • Conduct interim DMPK analyses, interpret the data and attend client meetings to discuss study progression
  • Assume responsibility as deputy principal investigator according to animal welfare laws for all animal studies
  • Responsible for compliance with German law, GLP, GCP, guidelines and other applicable regulation (e.g., radio protection) pertaining to the R&D process, study conduct, and registration of drugs
  • Responsible (and accountable as per delegation) for and enforce adherence to safety measures in laboratories

 

Your profile :

  • University degree in the field of veterinary medicine, biology, pharmacy or equivalent natural sciences
  • In-depth knowledge of ADME principles and working knowledge of mouse and rat anatomy
  • At least 2 years professional experience in DMPK within a pharmaceutical environment
  • Experience in handling radioactive compounds
  • Experience with Phoenix WinNonlin
  • Experience in conduct of GLP compliant studies
  • Experience in authoring study reports and submission relevant dossiers
  • Qualification as principal investigator according to German animal welfare laws
  • Fluent in English (written and spoken), advanced knowledge in German

Please send your application to Noemie Oliva at noliva@axepta.com

Senior Project Manager Bioanalyses

My client, a growing mid-size pharmaceutical services company is currently growing their activities therefore looking for a Senior Project Manager Bioanalyses to set up the bioanalytical laboratory for the company in their office in South of France (PACA region).

 

Your responsibilities:

  • Support starting up the bioanalytical laboratory in this new site.
  • Train and coach principal investigor(s) in regulated bioanalysis in order to facilitate successful GLP inspection
  • Moderate the change management in the bioanalytical laboratory in the transition process from an internal R&D laboratory to a CRO
  • Transfer existing standard operating procedures into SOP management system; support harmonizing procedures where needed and implement already harmonized procedures in this site
  • Implement method development and validation guide
  • Mentor and coach principal investigator(s)/project manager(s) to increase level of professionalism and give them deeper insight in Sponsor’s expectations.
  • Leverage experience in state-of-the-art LIMS during the implementation process of Watson LIMS on a global scale
  • Act as (deputy) project manager mainly during absence of principal investigator(s)/project manager(s)

 

Your profile:

    • Master degree in chemistry, specialized in analytical chemistry and biochemistry.
    • At least 15 years of experience in Bioanalyses
    • Experience in Pharmaceutical industry and working with CROs
    • Experience in Project Management and leading study teams
    • Knowledge of bioanalytical methods (LC-MS/MS, HPLC-UV/FD, etc.)
    • Experience in managing and guiding teams as Project Manager
    • Very good communication skills in English are required

Pleasesend your application to Noemie Oliva at noliva@axepta.com 

Head of Global Regulatory Affairs-Food Supplements

 

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their Global Regulatory Affairs team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Head of Global Regulatory Affairs with experience working on Food Supplement/OTC products.

 

Responsibilities:

  • Ensure that regulatory strategy follows local and international regulatory requirements for food supplement products and OTC products
  • Represent the company in Health Authorities ‘meetings
  • Lead and Manage a Regulatory Affairs team
  • Ensure professional development of individuals
  • Act as Global regulatory representative
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current regulation
  • Bring strong expertise in regulatory affairs on cosmetics

 

Your profile:

  • Lifescience Degree, Master or any equivalent advanced scientific degree in a related technical field.
  • Minimum 10 to 15 years of Experience in global Regulatory Affairs with strong experience in the Consumer Care environment (OTC drugs/Food Supplement).
  • Leadership, direct management, mature interpersonal, communication and organizational skills, direct and mobilize team around common goals and objectives, manage through efficient delegation, encourage and support individual’s development
  • Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.

Please send your application to noliva@axepta.com 

Head of Chemical Development

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Head of Chemical Development to join their growing development group.

 

Responsibilities:

 

  • Lead, design and oversee drug substance development
  • Lead, design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site
  • Contribute to the definition and the implementation of the Pharmaceutical Development strategy
  • Propose the Chemical Development strategy, identify and implement the necessary actions and solutions
  • Provide expertise and leadership in the development, communication and implementation of the small molecules chemical development strategy in support of product portfolio execution
  • Contribute to chemical development activities at early stages and operate in close cooperation with Research
  • Lead and organize chemical development late stages
  • Elaborate chemical development strategy in line with Quality by Design guideline
  • Identify, select and maintain a pool of CDMOs in close cooperation with Research, Procurement and Quality Management
  • Oversee Drug Substance CDMO activities and ensure implementation of the plans
  • Assess all major deviations and any out of specifications results that impact drug substance quality and release
  • Take into account current and evolving requirements and guidelines to ensure that the content of Drug Substance work packages and documentation are phase appropriate
  • Act as voice and ambassador of the Chemical Development function in governance bodies and meetings
  • Interacts closely with the Pharmaceutical Development Expert to support CMC drug substance development strategy and ensure consistency throughout the development
  • Contribute to the project pharmaceutical development plan including milestones, external costs and internal resources needs
  • Ensure projects meet agreed timelines and budget
  • Monitor, assess and proactively contribute to implement guidelines and/or scientific and technology trends (i.e. new technologies) that impact chemical development activities
  • Actively contribute to the preparation of audits and inspections, internally or at external partner’ site

Your profile:

  • PhD in Chemistry, MS in Chemistry, Chemical Engineering or closely related to the field and at least 10+ years of relevant experience
  • Established track record of success with drug substance development including botanical drug substance
  • Experience working with external partners (e.g. CDMO, CRO, Academic)
  • Sound technical qualifications and deep knowledge in developing and transferring drug substance manufacturing process
  • Laboratory experience in the field
  • Solid understanding of process engineering and characterization of the drug substance
  • Excellent understanding of cGMP, Pharmacopeia, ICH guidance and applicable guidelines
  • Experience in authoring analytical-related CMC sections of IND/IMPD and NDA/CTD regulatory submissions
  • Practical experience in implementing the principles of Quality by Design
  • Knowledgeable in statistical analysis and design of experiment
  • Excellent communication, negotiation and external follow-up
  • Excellent verbal and written communication skills (English) and the ability to work in a team environment with cross-functional interactions

 

For more information please contact Noemie Oliva at noliva@axepta.com 

Senior Global Program Leader-Cosmetics

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Global Program Leader with experience working on Consumer Cosmetics Skin care Product.

 

In this challenging and dynamic role, you will be part of the Global Program Management team and will report to the Global Head of Development.

 

Responsibilities:  

  • Drive Innovation Projects within the Brand including Project management & key innovation projects;
  • Support Brand Head to define strategy and prioritization to build short, mid and long-term innovation plan within budget and resources;
  • Ensure alignment and coordination with scientific and technical functions within Brand Committee and other main stakeholders of the business;
  • Bring program recommendations to the relevant board in alignment with Brand Head for project start, gate changes, mitigation plans and other critical business decisions;
  • In addition, take direct line management responsibility of one to several dedicated Project Leaders.
  • Deliver product(s)/process(es)/system(s)/solution(s) with defined quality at defined time and cost;
  • Contribute to the future commercial success of the business by considering the whole picture of the project
  • Effectively control scope changes through proactive and open communication with stakeholders;
  • Drive development of Innovation Strategy, Platforms & Concepts;
  • Ensure forward thinking insights are developed and utilized in idea & innovation generation and development;
  • Ability to identify & propose appropriate resource levels (people, funding, capacity, etc.) based on relative project importance and complexity;
  • In a matrix like organisation: Ensure adequate resources and competence levels, manages the resources (including budget) allocated to the project;
  • In a project organisation: Manage fully the project team. Manage Project Leaders / senior specialists being responsible for smaller projects / subprojects;
  • Contribute to training Project Leaders and Project team
  • Manage among stakeholders, negotiate with CC SIG decision makers and business partners internally and externally;
  • Create a dynamic, entrepreneurial and externally-facing team focused on the successful delivery of the project objectives.
  • Collaborate with multi-functional resources in the delivery of specific innovation projects;

 

Your profile :

  • PhD, Life Sciences or equivalent;
  • Fluent in English;
  • Minimum of 10 years of experience in R&D, Operations and/or Corporate Functions;
  • Proven FMCG experience or similar experience in cosmetic industry;
  • Minimum 5 years project management experience;
  • Successfully led a small- to medium-sized group of people and has developed people as project manager or team leader/group manager;
  • Demonstrated ability to take decisions and solve problems;
  • Proven communication skills (presents confidently and convincingly to steering committees)

Please send your application to noliva@axepta.com 

Director of Site Engineering-Biologics

My client is a growing pharmaceutical company based in the French part of Switzerland currently developing a new manufacturing site.

Due to this growth, my client is looking for a Site Engineering Manager/Director with strong experience working with Biologics environment.

Responsibilities:

  • Responsible for the overall supervision of the facility within the GMP Manufacturing.
  • Support the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment utilized in the production of biopharmaceutical drug substance during the construction phase and then when the site will be validated.
  • Upgrade and maintenance of the Biologics manufacturing Facility ensuring that defined standards, including cGMPs and approved manufacturing process/product specifications, are upheld in all aspects.
  • Responsible for process automation and manufacturing execution systems
  • Lead and manage the facility team to ensure the housekeeping of the site
  • Understand and implement internal policies, procedures and specifications required to insure the manufacturing activities.
  • Provide technical support to the validation activities
  • Interface with stakeholders to ensure the design, execution and delivery are in accordance with Good Engineering Practices, Quality, Environmental and Safety procedures.
  • Provide equipment and system mechanical completion walk-downs, safety walk-downs, system energization plans, lock-out tag-out, and review and approval of equipment installation manuals
  • Reviews all process changes at the site and any of specified contractors in collaboration with QA and Manufacturing.
  • Collaborate with plant management in resolution of any production problems, provide analytical trouble-shooting support and assure effective corrective actions to roots causes.
  • Assure site readiness for regulatory inspections including providing support for inspection preparation activities.
  • Develop the annual budget for the relative areas on responsibilities

Your profile:

  • Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing, Mechanical Engineering
  • Must have at least 10-15 years manufacturing experience in a Pharmaceutical company.
  • Experience in the biologics production is mandatory
  • Fluent in English and French
  • Excellent technical knowledge of clean and black utility systems: WFI, Clean steam, Process compressed air and HVAC, BMS systems, Cooling towers, Chillers, Boilers, Water softeners, Air compressors
  • Experience in commissioning and qualification in a GMP biotech manufacturing environment Excellent understanding of Utilities / Reliability Maintenance
  • Experience in engineering, construction, commissioning and validation in a GMP biotech manufacturing environment, or an equivalent combination of education and experience

Please send your application to noliva@axepta.com  

Senior Formulation and Innovation Manager-Switzerland

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Formulation and Innovation Manager to join their Strategic Innovation department

In this challenging and dynamic role, you will be part of the Global Product Development team and report to the Global Head of Product Development.

Responsibilities:

  • Lead a team of specialists (formulators, analysts, …) responsible for delivering innovative products.
  • While working with a team of formulation Scientists, the individual is expected to be flexible and act as the Formulation Project Leader in the project core team and perform hands-on activities in the formulation laboratories;
  • Work in collaboration with other functions on innovation projects ranging from gaining fundamental technical understanding of the formulation and its ingredients, to proof of principle, full development and market;
  • Ensure identification of new opportunities and be responsible for leading early stage innovation projects for the brands;
  • Ensure rigor and consistency in applying external best practice, cutting edge tools / processes / technologies within product development team;
  • Ensure projects meet agreed timelines and budgets;
  • Work in collaboration with other R&D functions, Marketing, Production units and others on projects ranging from gaining fundamental technical understanding of the formulation and its active ingredient, to proof of principle, to full development and market;
  • Manage day to day project priorities and ensure team activities are in accordance with the company standards and regulations, taking into account scientific, budgetary, timing objectives and direction from line manager.
  • Identify,, assess and drive forward key innovation opportunities for the brand
  • Acts as the product development point of contact for identified innovation opportunities for the brands, as the Formulation Project Leader in the Core team
  • Build and execute product development strategies in line with innovation briefs
  • Perform hands-on activities in the formulation laboratories when needed to optimize formulation resources and ensure delivery of projects within agreed timelines;
  • Ensures all product development activities are developed in accordance with policies, laws, quality standards, SOPs and safety requirements.
  • Authors documents, provides consultation, review and guidance to support product registration.
  • Authors and updates SOPs when/if needed to improve WOWs and processes;
  • Provides technical leadership and direction to the Team;
  • Provides opportunities for training, development and coaching/guidance when needed.
  • Accountable for the performance of his group (timelines, deliverables, resources);
  • Provide relevant input to budgeting and resourcing processes.

 

Your profile:

  • PhD+5 or Master +10 or equivalent in formulation, chemistry or related science; Full proficiency in English;
  • More than 10 years’ experience within cosmetics, or OTC products development in an international company;
  • Proven track record of launching innovative cosmetics or OTC products in a FMCG/FMCH international company;
  • Ability to work in a matrix organization and manage teams;
  • Excellent oral and written communication skills at all levels within the organization and strong technical writing capability;

Please send your application to Noemie Oliva at noliva@axepta.com

Head of Drug Metabolism and Pharmacokinetics

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Head of Drug Metabolism and Pharmacokinetics with experience working on Skin care and Biological Products to join their Strategic Innovation department.

 

Responsibilities:

 

  • Responsible for the strategy, conduct and interpretation of the global pharmacokinetic activities required for the optimization, selection and early clinical development of future systemic (oral, biological) and topical drug candidates
  • Participate in the implementation of the Research Strategy in line with the overall strategy and implements the corresponding technological solutions
  • Propose the strategy in DMPK in line with the global strategy and implements the corresponding technological solutions
  • Contribute to the evaluation and prioritization of projects in the Research portfolio
  • Define the needs, selects and maintains a pool of CRO partners to conduct the DMPK activities needed to implement the strategy
  • Organize and lead interaction with CRO partners for all DMPK activities required for research and early clinical evaluation activities of oral, organic, and topical projects
  • Organize and direct the DMPK activities needed to support preclinical safety studies and support the early clinical evaluation of oral, organic systemic projects and topical projects
  • Organize and direct the DMPK collaborations and the modelling of the human pharmacokinetics necessary for an initial assessment in humans
  • Contribute to TI / TV activities to maintain an innovative and competitive research project portfolio
  • Ensure the identification, selection and management of strategic collaborations of the Research Department
  • Contribute to the management of the global research budget
  • Contribute to maximizing the value proposition of Research and Development projects

Your profile :

  • PhD in Pharmacokinetics or in a specialty in related field such as metabolism, modelling, carriers etc.
  • Minimum of 15 years of expertise in academic or industrial research in the field of in vitro and in vivo pharmacology associated with human health.
    • Experience with biology including the biology of the skin.
    • Strong knowledge or experience of topical, oral and injectable pharmacokinetics in drug design projects
    • Academic or experiential training in the drug discovery and development process
    • Good knowledge of skin biology and dermatological pathologies as well as an excellent knowledge of development processes in the Pharmaceutical industry in general and early clinical development in particular.
    • Fluent in English (Oral and Written)

Please send your application to Noemie Oliva at noliva@axepta.com

Global Head of Regulatory Affairs Cosmetics/OTC

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their Global Regulatory Affairs team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Head of Global Regulatory Affairs with experience working on Cosmetics/OTC products.

 

Responsibilities:

  • Ensure that regulatory strategy follows local and international regulatory requirements for cosmetic products and OTC products
  • Represent the company in Health Authorities ‘meetings
  • Lead and Manage a Regulatory Affairs team
  • Ensure professional development of individuals
  • Act as Global regulatory representative
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current regulation
  • Bring strong expertise in regulatory affairs on cosmetics

 

Your profile:

  • Lifescience Degree, Master or any equivalent advanced scientific degree in a related technical field.
  • Minimum 10 to 15 years of Experience in global Regulatory Affairs with strong experience in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices).
  • Leadership, direct management, mature interpersonal, communication and organizational skills, direct and mobilize team around common goals and objectives, manage through efficient delegation, encourage and support individual’s development
  • Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.

Please send your application to Noemie Oliva at noliva@axepta.com

 

Regulatory Affairs CMC Expert-Biologics

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Global Regulatory Affairs CMC Expert-Biologics with experience working on Biologics Product.

 

Responsibilities:

  • Responsible for preparing and updating the CMC sections of assigned products
  • Support the RA Managers for regulatory strategy of development and commercial products.
  • Prepares CMC sections for investigational and commercial products (IMPD, IND, MAA, NDA, …).
  • Establishes data requirements for CMC changes with Pharmaceutical Experts and Operations teams.
  • Follows new CMC activities from initial project plan, dossier preparation, support for registration and confirmation of revised status.
  • Writes/assembles pharmaceutical sections of Investigative Product CMC sections.
  • Writes/assembles CMC sections of registration dossier
  • Prepares responses to Questions from Competent Authorities, if needed.
  • Advise/validate regulatory feasibility and strategy of proposed CMC modifications with Pharmaceutical Experts and Operations (Change control)
  • Reviews data provided to support updates/variations; prepares variation dossiers, supports registration and communicates final outcome.
  • Ensures all CMC dossiers are stored in the company database and are kept current.
  • Responsible for management of the service provider contracted to support a project

 

Your profile:

  • BSc, MSc in a scientific discipline or Pharmacist
  • 5 years in a Pharmaceutical Company in a Pharmaceutical Development, Quality or Regulatory Compliance Departments, as well as 2-3 years CMC Regulatory experience.
  • Experience working with Biologics product is a must
  • Focused on effective delivery of objectives, even when working with tight deadlines
  • Effective verbal and written communication skills in a cross functional environment
  • Fluent in English

Please send your application to noliva@axepta.com

 

Senior Medical Expert-Dermatology or Oncology

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Senior Medical Expert with experience working on Oncology or/and Dermatology therapeutic areas.

 

In this challenging and dynamic role, you will be responsible to provide a medical strategy, leadership, and expertise to individual (phase I, II, III and IV) clinical trials within a development program.

 

Responsabilities :

  • Accountable for design, implementation, execution, and submission/approval of a clinical development plan to support decision milestones, regulatory requirements, and budget targets
  • Supports the development and execution of the Clinical Development Plan (CDP), adhering to the company’s clinical/data standards of quality for Phase I – II – III – IV trial
  • Ensures from a medical perspective that individual protocols are consistent with CDP and are aligned to achieve the Target Product Profile (TPP)
  • Supports Clinical development team for protocol development and full protocol package processing
  • Responsible for advising investigators and/or CRO on medically relevant questions during study execution
  • Supports Clinical development team for scientific aspects of data review/SSRM/coding/edit checks/CRF/DMC/other study documents
  • Develops presentation materials for trial-related advisory boards, investigator meetings, and protocol training meetings
  • As required, establish, implement, and support IDMC
  • Accountable for excellence in clinical trial strategy, design, execution and reporting ensuring high quality data is obtained
  • Responsible for continuous evaluation of drug benefit risk profile, including the aspects of relevance to patients in clinical studies, as well as external stake holders (e.g., health authorities) in collaboration with Global Safety group
  • Supports ongoing review of clinical trial data, final analysis, and interpretation in collaboration with development team members
  • Provides medical strategy (i.e. medical rationale, objectives and end points) to clinical development protocols, plans, study outlines, investigator brochures, briefing packages, CTDs, draft labels, and other documentation as required
  • May interact with external and internal stakeholder in support of Research and/or Strategic opportunities including:  target identification, review of programs at preclinical stage and due diligence, together with other medical matters as required
  • May serve as disease area scientific and medical expert with external stakeholders (e.g., regulatory authorities, CRO, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders
  • Delivers all relevant components/documents for maintenance of product licenses
  • Participates in scenario development for clinical development to support decision analysis and optimal resource allocation in program
  • Supports team to manage, forecast, and allocate resources for the clinical program as needed
  • Accountable for timely execution of clinical deliverables within approved budget

 

Your profile :

  • Medical Degree required, experience in conducting clinical trials preferred, experience developing systemic agents (large and/or small molecule) and experience working within Dermatology preferred
  • Prior experience in clinical research or drug development in an academic, CRO, or industry environment (industry experience preferred)
  • Experience with regulatory submissions and health authorities preferred
  • Must possess strong interpersonal and problem solving skill
  • Demonstrated experience in data presentation
  • Experience in conducting clinical trials
  • Fluent in English, written and oral

Please send your application to noliva@axepta.com