Auf Arbeitssuche

Das Execruit-Team bringt ein unvergleichbares professionelles Engagement mit, um Ihre Anforderungen in den Bereichen Talent-Rekrutierung, Führungsentwicklung & Beurteilung, Karriereentwicklung, Outplacement und E-Learning zu erfüllen.

Switzerland
Posted 2 Jahren ago
Key responsibilities:
  •  Contribute to Vendor selection and qualification process, assess Vendor’s procedures during selection process, guaranteeing compliance with regulatory requirements & verify G(c)LP certification, for TM vendors contributing to numerous PK & biomarkers assessments in DPI’s pre-clinical and clinical programs
  • Collaborate with the TM Subject Matter Experts to ensure proper DPI set-up & oversight of outsourced activities
  • Support “risk/impact assessments” related to TM activities & respective vendors contributing to DPI pre-clinical and clinical programs
  • Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation
  • Create Key Quality Indicators to identify areas for improvement based on risk-based compliance activities and audit observations
  • Lead & contribute to compound-specific Regulatory Authority inspections / due diligence activities
  • Build collaborative working relationships and ensure adequate communication within the TM organization and cross-functional Quality peers
  • Lead coordinating the execution of Master Audit Plan executed by external auditors, assist the TM business stakeholders to ensure proper CAPA formulation and follow-up
  • Contribute to the development/maintenance of Quality and Translational Medicine related  Procedural Documents
  • Ensure training on proper knowledge and understanding on latest G(c)LP guidelines, DPIs. Procedural Documents and regulations of identified stakeholdersYour profile:
  • A master’s degree in a scientific discipline or equivalent combination of education and experience
  • 7 – 10 years’ experience in the Pharmaceutical of Biotechnology industry with a minimum of 5 years in Quality Management or Regulatory Compliance Role
  • Current and working solid knowledge in GLP, GcLP and regulatory guidance including, ICH, quality, non-clinical, clinical, multidisciplinary guidance documents and 21 CFR Part 11 compliance
  • Ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization
  • Strong problem-solving and analytical skills
  • Knowledge of root cause analysis tools/methodologies
  • Strong team player, with excellent interpersonal communication skills
  • Used to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Self-dependent way of working; taking ownership of assigned tasks; plan and deliver according to agreed timelines

Job Features

Job CategoryRESEARCH

Contribute to Vendor selection and qualification process, assess Vendor’s procedures during selection process, guaranteeing compliance with regulatory requirements & verify G(c)LP certification, for...

Switzerland
Posted 2 Jahren ago
Key responsibilities:
  • Lead, develop and implement the global RA strategy for assigned project.
  • Represent RA in Project Teams and in various other cross-functional teams, such as Clinical Study Teams
  • Present and defend regulatory plans to internal governance bodies
  • Represent as the primary interface for FDA/EMA/other Regulatory Agencies on assigned projects, including coordinating and leading meetings with these Agencies.
  • Be accountable for the preparation of submissions in several jurisdictions, such as: INDs/CTAs, Briefing Documents to support meetings with Regulatory Agencies, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc
  • Work closely with functional experts to coordinate their contributions to regulatory documents
  • Review and approve documents of regulatory relevance such as Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, etc
  • Manage and oversee external vendors, such as CROs
  • Contribute to the assessment of new in-licensing opportunities and represents RA in out-licensing teams
  • Maintains knowledge of global competitive and regulatory landscape
  • Contribute to the assessment of the impact that changes might have on assigned projects
  • Contribute to establishing and revising standard operational procedures to maximize the efficiency of processes and ensure compliance to regulations.
  • Leads regulatory sub-teams, as appropriate.
  • Coaches junior RA professionals and may have line function management responsibilities.
Your profile:
  • Bachelor’s degree in life-sciences; a higher degree is preferred
  • At least 10 years of regulatory affairs experience in the field of innovative new drugs, preferably in oncology or anti-infectives, with thorough knowledge of the overall drug development process. Experience with regulatory strategies for life-cycle management is an additional asset.
  • Demonstrated experience with:
    • Development and implementation of regulatory strategies for innovative new drugs, from pre-clinical stages up to registration.
    • Experience with NDA/MAA submissions or post-marketing activities is an additional asset
    • Leading cross-functional teams for preparation of regulatory deliverables
    • Various regulatory procedures in the U.S. and Europe; experience with regulatory procedures in other jurisdictions is an additional asset
    • Managing and overseeing regulatory activities for global clinical trials up to phase III.
    • Leading meetings with Regulatory Agencies
    • You are independent, results driven, team-oriented with the ability to work in cross-functional teams within a matrix organization
    • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
    • Demonstrate excellent written and verbal communication skills in English

Job Features

Job CategoryLIFE SCIENCES, REGULATORY AFFAIRS

Lead, develop and implement the global RA strategy for assigned project. Represent RA in Project Teams and in various other cross-functional teams, such as Clinical Study Teams. Present and defend reg...

Switzerland
Posted 2 Jahren ago

Your responsibilities will be but not limited to:

  • Lead the overall initiation, coordination, implementation and management of Phase III international clinical trial
  • Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
  • Manage operational and technical aspects of projects including budgeting, timelines and risk management
  • Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
  • Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
  • Monitor vendor and CROs performance and ensure continuous oversight
  • Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
  • Represent clinical operations on multi-function project teams internally and externally, if needed; report on study progress
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans
  • Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
  • Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
  • Design, review and approve of all trial related documentation, and establish trial processes
Requirements:
  • Bachelor or Master’s degree or equivalent in Life Sciences
  • Proven track record of 5-7 years of experience as Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase III studies from set-up to close-out
  • As Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology
  • Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
  • Customer oriented and strong team-spirit with the ability to lead a cross-functional team and foster a collaborative team environment to work effectively with others in a fast-paced matrix organization
  • Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
  • A first experience in external audits is an asset
  • Strong negotiation skills, scientific knowledge and involvement
  • Former experience in contributing to protocols and clinical development plans
  • Fluent in English – French is an asset
  • Travel up to 20%

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology – hematology) taking into account current medical practice and unmet needs; advances in both biologic...

Key responsibilities:

  • Provide expert statistical input to the design, analysis and interpretation of clinical studies, and development plans, primarily within Oncology
  • Ensure provision of quality and timely statistical analyses results that support quality and timely decision making
  • Lead statistical and programming study teams and perform statistical analyses
  • Provide statistical oversight and guidance to study teams and outsourcing CRO partners, ensuring CROs’ accountability for the quality of their deliverables
  • Represent statistics within cross functional study teams and project sub-teams and provide statistical support and solutions
  • Provide statistical support for briefing books, submissions, health authorities’ requests, publications, and other relevant documents, as assigned
  • Participate in interactions with Health Authorities
  • Maintain current scientific and regulatory knowledge
  • Provide input/lead internal process improvement and/or new statistical capability
Requirements:
  • MSc. or PhD in statistics or related field
  • At least 5 years’ experience as project/study statistician in Clinical Development in the pharmaceutical industry
  • Experience of development program design and data analysis working on Oncology studies
  • Strong statistical methodology knowledge and implementation. Experience using Bayesian designs is a plus
  • Proven experience and programming skill in SAS or R
  • Up to date knowledge of regulatory requirements related to statistics
  • Continuous improvement mindset and looking to bring best practices
  • Effective communication and ability to build positive relationships with internal and external stakeholders
  • Team player, looking to be part and contribute to the team success

Job Features

Job CategoryBIOSTATISTICS, CLINICAL DEVELOPMENT, LIFE SCIENCES

Provide expert statistical input to the design, analysis and interpretation of clinical studies, and development plans, primarily within Oncology

Key responsibilities:

  • Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration
  • Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
  • Manage operational and technical aspects of projects including budgeting, timelines and risk management
  • Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
  • Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
  • Monitor vendor and CROs performance and ensure continuous oversight
  • Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
  • Represent clinical operations on multi-function project teams internally and externally, if need[1]ed; report on study progress
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans
  • Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
  • Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
  • Design, review and approve of all trial related documentation, and establish trial processes

Your profile:

  • Bachelor or master’s degree or equivalent in Life Sciences
  • Proven track record of 5-7 years of experience as Global Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase I & II studies from set-up to close-out
  • As Global Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology (a must)
  • As Global Clinical Trial Manager, you have worked on studies including radiopharmaceutical compounds
  • Experience in leading global clinical studies in Phase III is an asset
  • Experience in pharmacokinetic studies (e.g. DDI, ADME) is an asset
  • Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
  • Customer oriented and strong team-spirit with the ability to foster a collaborative team envi[1]ronment and to work effectively with others in a fast-paced matrix organization
  • Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
  • Experience in external audits, an asset
  • Strong negotiation skills, scientific knowledge and involvement
  • Former experience in contributing to protocols and clinical development plans
  • Fluent in English – French is an asset
  • Travel: up to maximum 20%

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology – hematology) taking into account current medical practice and unmet needs; advances in both biologic...

Switzerland
Posted 2 Jahren ago

Key responsibilities:

  • Drive the development of protocols/protocol amendments for clinical studies
  • Prepare and/or provide input to clinical study-related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
  • Work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical trial
  • Contribute to the development of end-to-end clinical development strategy
  • Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
  • Monitor, review and interpret safety and efficacy data of ongoing clinical trials
  • Act as (clinical science expert) liaison to cross-functional project core team, clinical study teams, CRO's, study sites and others
  • Establish relationships with investigators, KOLs, partners and appropriate consultants
  • Provide clinical scientific input to business development (e.g. due diligence) and marketing activities
  • Perform literature research
  • Develop and deliver presentations to internal and external stakeholders. Provide input in scientific communication plan and scientific publications
Your profile:
  • Master's in Life Sciences, Pharmacist or PhD in Life Sciences (preferred)
  • At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including the development of CDPs and protocols
  • Experience in conducting Clinical Studies in Oncology
  • First experience working on studies in Anti-infectives in an asset
  • Broad experience in the principles and techniques of data review, analysis, signal detection, interpretation and clinical relevance
  • Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations
  • knowledge of the multidisciplinary functions involved in the drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end-results.
  • Driven and proven abilities to perform responsibilities independently and with limited guidance
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget delivery. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
  • Strong interpersonal, verbal/written communication, negotiation and influencing skills in English
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams. Demonstrate curiosity and challenge status-quo

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology – hematology) taking into account current medical practice and unmet needs; advances in both biologic...

Key responsibilities: • Develop clinical strategy for the therapeutic area in the assigned endocrinology & rare disease programs, taking into account current medical practice and unmet needs; advances in both biological sciences and data sources; as well as competitive environment • Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned program(s) to ensure: successful delivery of the development plan, anticipation and dealing with uncertainties; generation of scenarios and relevant information for decision making; and managing risks.Clinical deliverables may include but are not limited to clinical study synopsis and protocol(s), Investigator Brochure, program specific standards, clinical components of regulatory documents/registration dossiers, publications, and in-/out licensing activities • Deliver and execute the clinical development plan(s) in collaboration with study teams by ensuring: efficient execution of protocols, appropriate study medical monitoring, timely resolution of issues and reporting of study results including communication at congresses • Be an integral member of the clinical development team and drive execution of the clinical program(s) in partnership with other functions (e.g. Clinical Scientist(s), Project Management, Clinical Operations, Biostats, Regulatory Affairs and Business functions) to support decision milestones, regulatory requirements, market access and potential out licensing • Responsible for the generation of the Clinical Development Plan (CDP) and is a major contributor to the Target Product Profile (TPP) and Integrated Project Plan (IPP). Present CDP and other study project-related topics to Leadership Team for validation • Consult with internal and external experts for the generation of an innovative and optimal Clinical Development Plan including design and timing of individual study protocols • Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., Study Teams, Translational Medicine, Regulatory Affairs), and internal decision boards • Provide Clinical Development input in due diligences both for the in-licensing and out-licensing of compounds • Management and supervision of Medical Director(s) within the project or of other project(s)   Your profile: • Medical Doctor with adequate clinical experience in endocrinology • Expertise in acromegaly / gastroenteropancreatic neuroendocrine tumours is a plus and expertise in hemato-oncology or radio-oncology is a strong plus • 7-10 years of successful and solid experience in endocrinology early and late drug development, from First In Human to Phase III study in the pharmaceutical industry, including in best practice big pharma • Evidence of keeping up to date with the recent development in clinical practice and scientific progress • Track record of having led at least one oncology development program through different stages • Proven track record delivery and publication of clinical trials in endocrinology. Openmindedness, flexible, with a high level of scientific / medical curiosity and strategy mindset; • Being able to deal with uncertainty, manage risks and drive a proper decision making • Proven strategic thinking and innovative mind-set, combined with project management and operational skills • Leadership and ability to collaborate in a team within a matrix organization, while remaining autonomous and entrepreneurial minded • Proven ability to establish strong scientific partnership with key stakeholders • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process and of ensuring compliance with GCP, SOPs, and regulatory requirements

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology – hematology) taking into account current medical practice and unmet needs; advances in both biologic...

Switzerland
Posted 2 Jahren ago
Key responsibilities:
  • Work closely with the Global Program Head(s) and Global Project leaders (GPLs) to support/contribute with the development of the program strategy and its integrated development plan, ensuring consistency with the target product profile as well as cross-functional alignment
  • Contributes and/or coordinates development of strategic documents and prepares for phase transitions in collaboration with the Development teams
  • Responsible for strategy implementation and operational execution of the program, quality and accuracy of program plan and forecast in enterprise planning systems and providing guidance to maintain realistic program plans ensuring cross-functional alignment
  • Coordinates team objective setting, prioritization and tracking, collaborates with teams to identify key program issues. May lead or participate in ad-hoc cross-functional sub-teams and task forces to address and resolve issues
  • Contributes to risk assessment and contingency planning and communicates program status with the respective stakeholders in a transparent and timely manner
  • Supports Global Program Head(s) and Global Project leaders in preparation of comprehensive program recommendations, board meeting presentations and updates for governance boards
  • Reports on projects progress and deliverables.
  • May manage/support external partnerships/collaborations
  • Provides operational leadership to assigned teams; prepares and manages the effective coordination and facilitation of cross-functional team meetings from a program management perspective. Ensures team meetings have prepared agendas, allot adequate time for presenters, issue high quality meeting summaries/minutes, Responsible for identifying and capturing action items and for liaising with team members on follow-up activities and deliverables
  • Contributes to functional excellence by supporting implementation of PM standards, team objectives, project documentation and communication
  • Provides Program Management expertise and leadership in the areas of planning, tracking, scenario-generation, contingency development, critical path analysis, and risk management
  • Develops and manages global, integrated cross-functional plans by:
    • Identifying key deliverables for each function
    • Understanding and outlining inter-dependencies
    • Ensuring cross-functional alignment and accountability
    • Coordinating project level budget/forecasting and managing project procurement activities
    • Monitoring progress and adherence to timelines
    • Identifying project risk and issues and facilitating resolution
    • Support the project resource planning to assure that adequate resources are allocated to the program
  • Actively establish and maintain a close partnership with the Clinical Study teams and program extended teams to ensure alignment and overall program execution
  • Assure functional deliverables are completed on time, on budget and according to quality standards; you take a hands-on approach if required to support the various teams
  • Prepare and present monthly reporting to team and stakeholders to show progress, results; anticipate risks and provide recommendations and solutions
  • Maintain documentation and tracker on program changes and decisions impacting the program execution are assessed in regard to timelines, budgets, resources and documentation of endorsed changes & decisions by relevant Management Committees.
  • Keep and maintain the program’s strategy and scope documentation.
  • Manage the Integrated Development Plan and support the risk assessment process
  • Play an active role in driving process improvement & best practices on the program and in developing Project Management tools, templates, processes
  • Coordinate, elaborate and consolidate the writing of monthly, quarterly or annual reports of multi-projects progress and portfolio views, according to PMO good practice;
  • Coordinate, elaborate and consolidate the writing of quarterly or annual financial reports of projects and portfolio views, according to PMO good practice;
  • Actively contribute to promote the values of project management within the company, while maintaining a general information platform on PMO activities;
  • Support the PMO management in their administrative tasks, as well administrative tasks of one or more Global Project Leader where appropriate.
  • Supports Global Program Head(s) and Global Project leaders to role model a leadership style which is inclusive, proactive, change agile and results driven with a collaboration focus
  • Partner with R&D team members to derive to high performing team spirit with a trusting relationship, sharing responsibility and working towards joint goal
  • Support driving a continuous improvement mindset across the organization
Your profile:
  1. Science background, MS/ PhD preferred.
  2. 3-5 years of multi- / cross-functional experience on international and multidisciplinary drug development teams in pharma or biotech companies.
  3. Intermediate knowledge of special requirements of disease area specific drug development including regulatory and business requirements.
  4. 2-3 years of experience in Project Management for preclinical and clinical development, with hands-on project management skills, including project plans, timelines, budgets, resources, risk assessment and reporting.
  5. PMP or equivalent certification preferred.
  6. Excellent planning, anticipation, and organizational skills, and good analytical thinking.
  7. Ability to anticipate & troubleshoot problems.
  8. Strong interpersonal skills for bridging between scientific and business participants.
  9. Team player with an open mind, able to constructively accept feed-back and suggestions for improvement.
  10. Ability to handle multiple programs and responsibilities simultaneously on short notice and meet requirements in a fast-paced, high-expectation environments.
  11. Technology-savvy in all Microsoft Office applications; proficient in MS Project or similar planning tools.
  12. Fluency in English, second Language: German or French;

Job Features

Job CategoryPROJECT MANAGEMENT

Accountable for the key deliverables of the drug early development and pre-clinical project and lead a multidisciplinary team

Key responsibilities

  • Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology - hematology) taking into account current medical practice and unmet needs; advances in both biological sciences and data sources; as well as competitive environment
  • Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned program(s) to ensure: successful delivery of the development plan, anticipation and dealing with uncertainties; generation of scenarios and relevant information for decision making; and managing risks
  • Clinical deliverables may include but are not limited to clinical study synopsis and protocol(s), Investigator Brochure, program specific standards, clinical components of regulatory documents/registration dossiers, publications, and in-/out licensing activities
  • Deliver and execute the clinical development plan(s) in collaboration with study teams by ensuring: efficient execution of protocols, appropriate study medical monitoring, timely resolution of issues and reporting of study results including communication at congresses
  • Be an integral member of the clinical development team and drive execution of the clinical program(s) in partnership with other functions (e.g. Clinical Scientist(s), Project Management, Clinical Operations, Biostats, Regulatory Affairs and Business functions) to support decision milestones, regulatory requirements, market access and potential out licensing
  • Responsible for the generation of the Clinical Development Plan (CDP) and is a major contributor to the Target Product Profile (TPP) and Integrated Project Plan (IPP)
  • Present CDP and other study project-related topics to Leadership Team for validation
  • Consult with internal and external experts for the generation of an innovative and optimal Clinical Development Plan including design and timing of individual study protocols
  • Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., study teams, Translational Medicine, Regulatory Affairs), and internal decision boards
  • Provide Clinical Development input in due diligences both for the in-licensing and out[1]licensing of compounds

Your profile:

  • Medical Doctor with adequate clinical experience in oncology; Expertise in solid tumours is a must. Expertise in hemato-oncology or radio-oncology is a strong plus
  • 7-10 years of successful and solid experience in oncology early and late drug development (from First In Human to Phase III study) in the pharmaceutical industry, including in best practice big pharma
  • Evidence of keeping up to date with the recent development in clinical practice and scientific progress
  • Track record of having led at least one oncology development program through different stages
  • Proven track record delivery and publication of clinical trials in oncology an/or hematology. Open-mindedness, flexible, with a high level of scientific / medical curiosity and strategy mindset
  • Being able to deal with uncertainty, manage risks and drive a proper decision making
  • Proven strategic thinking and innovative mind-set, combined with project management and operational skills
  • Leadership and ability to collaborate in a team within a matrix organization, while remaining autonomous and entrepreneurial minded
  • Proven ability to establish strong scientific partnership with key stakeholders
  • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process and of ensuring compliance with GCP, SOPs, and regulatory requirements

Job Features

Job CategoryCLINICAL DEVELOPMENT

Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology – hematology) taking into account current medical practice and unmet needs; advances in both biologic...

Switzerland
Posted 2 Jahren ago

Key responsibilities

  • Bolster the in-licensing pipeline with innovative oncology products by:
  • Driving scouting activities in selected territories
  • Developing new digital scouting methodologies to identify licensing opportunities
  • Prepare, conduct, and follow up partnering discussions at international partnering events
  • Regularly nurture contacts with high-potential companies having preclinical/early clinical therapeutic pipelines, in alignment with the company’s licensing focus
  • Champion programs at internal meetings during the early stages of the evaluation process
  • Facilitate follow-up interactions with potential partners for programs under evaluation
  • Maintain the internal database of in-licensing programs up to date
  • Collaborate with the evaluation and negotiation team during the in-licensing process
  • Valorize company’s technologies (e.g., MultilinkTM and AbYlinkTM) through the establishment of collaborations with biotech/pharma
  • Apply key learnings and insights from multiple external sources to foster innovation

Your profile

  • Advanced degree (PhD) in life sciences (oncology preferred)
  • At least 2-4 years professional experience in the pharmaceutical industry (sourcing
  • therapeutic assets, business analysis in pharma/biotech) or equivalent experience in
  • the academia
  • Business acumen, experience in partnering and licensing processes a plus
  • Outgoing, curious, creative, and versatile personality, with outstanding teamwork

Skills

  • Excellent command of English (written and verbal) and confidence to interact with Clevel stakeholders
  • Talent in creating/nurturing professional relationships
  • Structured approach to work, ability to prioritize and high resilience
  • High degree of self-motivation and ownership, with a positive “can-do” attitude
  • Excellent mastery of database manipulations and web-based communication channels
  • Availability to travel (approx. 15%)

Job Features

Job CategoryBUSINESS DEVELOPMENT & LICENSING

Regularly nurture contacts with high-potential companies having preclinical/early clinical therapeutic pipelines, in alignment with the company’s licensing focus

Switzerland
Posted 2 Jahren ago

Key responsibilities

  • Accountable for the key deliverables of the drug early development and pre-clinical project and lead a multidisciplinary team
  • Lead generation and update of early target product profile and drives development of the program strategy and its integrated program plan; you adapt the strategy and engage the project team in on-going reviews of the TMP and TPP considering new data, project constraints, risks and opportunities, with the aim of maximizing the compound potential value
  • Lead project team in development of strategic documents and phase transitions in collaboration with development and Commercial leaders
  • Prepare and present project progress reports to the "Early Project Review Committee” (EPRC)
  • Negotiate resource requirements with the functional heads and the EPRC to secure appropriate funding and staffing for project execution
  • Drive team objective setting prioritization and tracking according to the approved development plan and budget and ensure resources are used according to plan
  • Accountable for quality and accuracy of program plans and budget forecasts as well as realistic planning ensuring cross-functional alignment
  • Identify project risks and prepare mitigation and contingency plans in collaboration with project team members; identify and leverage project development opportunities
  • Foster project team and company commitment to the project to maximize chances of success & maintain regular communication on project progress
  • Help and coach each PT member to achieve their objectives and fulfill their mission
  • May participate or lead ad hoc cross-functional sub-teams to address and resolve issues; may manage external partnerships/collaborations
  • Organize program team meetings and provides operational leadership to the team

Your profile

  • PhD in Medicinal Chemistry or Biology combined with at least 7 years of experience in the Pharmaceutical Drug Discovery area, working in cross-functional multinational research or/and in drug development teams in Oncology
  • Good Knowledge of Regulatory Affairs and Business acumen in Oncology area
  • Proven track record as R&D project leader, including budget management, planning and in aligning team member with defined target & innovative operations approaches to achieving project goals
  • Role model inclusive, proactive and agile results-driven leadership style in a dynamic environment, you are used to mentor more junior cross-members joining your projects
  • Facilitator, team-player and open-minded, you collaborate with the several department involved to take feedbacks and build solutions
  • Your strong scientific knowledge makes you a reference point in the Early Development projects
  • Strong communication and relationship management skills as well as the ability to influence and align stakeholders at all levels in English
  • Good level of French (written and spoken) is an asset
  • Pragmatic and willing to drive and support change, supporting a culture of continual improvement and innovation, you promote knowledge sharing

Job Features

Job CategoryPROJECT MANAGEMENT

Accountable for the key deliverables of the drug early development and pre-clinical project and lead a multidisciplinary team

Switzerland
Posted 2 Jahren ago

Key responsibilities

  • Guide innovation, provide drug development expertise and strategic leadership to the Programs and project teams, comprising all pre-clinical, clinical, technical, regulatory, operational and commercial disciplines
  • Define the vision, overall development strategy and operational implementation for the assigned Programs based on regulatory and market requirements to obtain drug approval and maximize the out-licensing value of the Programs
  • Anticipate internal and external drivers of changes to strategy, and respond by making rapid, well-judged adjustments to the Programs roadmap
  • Identify potential issues and risks; develop, align and implement mitigation plans in a transparent and timely manner
  • Drive proactive scenario planning and risk taking paths across the project teams
  • Develop team effectiveness and lead high performing project teams to achieve superior results
  • Coach, manage and support employees to achieve business goals. Actively manage talent and career development
  • Jointly with the Global Line Functions and the Project Managers, align on staffing of Project Teams. Identify, resolve and escalate resource issues
  • Set goals, actively coach and contribute to the performance appraisal of the project team members in close partnership with the line-functions
  • Oversee execution of the Program strategy across all functions and sub–teams
  • Drive project operations in close partnership with the Project Managers
  • Communicate the strategy to the global project teams and functions, and ensure that the agreed strategy is reflected in the operational activities
  • Drive and steer the implementation of the Program strategy in close collaboration with the relevant functions within agreed timelines, budgets and resources
  • Define and implement clear measurable goals for program execution
  • Propose and manage, with the support of the ProjectManagers, the management of internal and external budgets related to the programs
  • Ensure adherence to quality and compliance
  • Represent the Programs internally and externally with objective advocacy of their potential and transparent disclosure of their risks
  • Secure internal alignment on vision and strategy with governance bodies, board members and across functions
  • Develop and maintain external communication strategy around the Programs targeting different stakeholders such as patients and potential out-licensing partners
  • Shape the external environment to strengthen the company position related to the Program by developing strong evidence and trust based relationships with key stakeholders (regulators, KOLs, patient groups, scientific societies)
  • Maintain and develop a positive organizational culture, by promoting the values of the focus on patients, science, collaboration and people
  • Actively engage with the Market Intelligence, Marketing, Market Access and Business Development teams for input on the Program

Your profile

  • PhD in life science, ideally in Microbiology (or MBA with equivalent experience in life science); Medical Doctoral degree preferred
  • At least 8 years of drug development experience with proven track record in leading multi-function drug development teams in Anti-infective
  • Extensive end-to-end global drug development experience in multiple therapeutic areas including Infectious Diseases. Proven proficiency in setting project vision and strategy and leading execution
  • Experience in Oncology is a plus
  • Project management experience, mastery of risk management and deep understanding of the requirements for successful commercialization of a new drug
  • Proven track record of R&D team leadership and management
  • Integrated strategic thinker across drug development functions with ability to scope and challenge their plans and deliverables
  • Successful track record of taking a pharmaceutical product to POC and /or registration & understanding of the drug development continuum from pre-POC to post-POC and commercialization
  • Solid expertise in critically interpreting scientific and commercial data and in translating interdisciplinary project information into action plans
  • Experience in interactions with global Health Authorities and in dossier submission for new indications
  • Proven ability to manage, mentor and coach experts from different functions
  • Ability to communicate seamlessly with scientific and business stakeholders, to negotiate timelines, resources and to foster effective collaboration to deliver results
  • Solid business acumen and competitive landscape understanding in the relevant therapy area
  • Excellent communication, presentation and influencing skills in English, French is a plus

Job Features

Job CategoryPROJECT MANAGEMENT

Guide innovation, provide drug development expertise and strategic leadership to the Programs and project teams, comprising all pre-clinical, clinical, technical, regulatory, operational and commercia...

Key responsibilities

  • Evaluate and establish the safety profile of this product in collaboration with the different company experts and/or partner vendors
  • Provide expert safety input to the clinical development program, study documents such as study protocols, informed consent, investigator brochures, Development Safety Update Report
  • Be responsible for safety surveillance activities for this product including medical review of individual safety cases directly in the safety database and signal detection activities (ongoing review of safety data)
  • Escalates and presents safety issues at company safety governance bodies
  • Ensure the oversight of medical activities outsourced to our PV vendor
  • Be a member of study teams and work in a collaborative and proactive way in a matrix environment.
  • Participate in IDMC meetings or other safety-related interactions with outside collaborators, and in internal safety task forces
  • Be involved in process optimization initiatives and, where needed, set up new activities

Your profile

  • M.D. diploma with at least 4 years experience as a Safety Physician in clinical safety in early clinical phases of drug development in a global pharmaceutical or global CRO
  • Firsthand experience in oncology drug development is a plus
  • Strong experience and knowledge of international clinical development regulations applicable to drugs
  • Experience with Safety Database
  • Experience and willingness to analyze and manage significant safety issues in clinical development
  • Ability, as a leader, to collaborate with cross-functional teams and facilitate communication and are able to make decisions
  • Able to work independently, to take responsibility for allocated projects/tasks, prioritize activities effectively, and meet multiple deadlines successfully with attention to detail, setting high-performance standards for quality
  • Ability to function effectively in high-stress situations
  • Demonstrate excellent written and verbal communication skills in English
  • Proficient in MS Office (Excel, Word, PowerPoint, Outlook, Teams

Job Features

Job CategoryDRUG SAFETY

Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines. Prepare, oversee, and review documents that are related to assigned clinical study.

Key responsibilities

  • Manage finance, budget and timelines related to assigned clinical pharmacology and pharmacometrics activities
  • Design, plan, manage (oversight of contractors when applicable) and report the pharmacometrics
  • studies (Non-Compartmental PK analysis, Population PK, PK/PD, Exposure/Response, Probability
  • of Target Attainment, PBPK, Modelling & Simulation) of DPI compounds in development
  • Manage the clinical pharmacology and pharmacometrics part of assigned clinical studies
    • Participate in the study design with regard to clinical pharmacology aspects
    • Participate in the preparation of informed consent forms, clinical protocol, SAP and CSR,
    • and other study-related documents
    • Determine, implement and manage the PK or PK/PD data analyses and reporting according to GCPs and regulatory guidelines
    • Contribute to the medical data review with regard to clinical pharmacology aspects (risk of drug-drug interactions and management of concomitant medications)
    • Ensure adequate filing of pharmacometrics study documents in the e-TMF
    • Be a member (as Clinical Pharmacologist) of one or more Clinical Study team(s)
  • Manage outsourcing activities to an international network of CROs (Europe, Asia and America) or through academic collaborations (preparation of RFP, contractors selection, contracts review and budget negotiation)
  • Contribute to the preparation of clinical pharmacology and pharmacometrics documentations to support the cross-functional activities (including PK chapters of regulatory documents
  • Participate in external scientific communications (publications, poster and oral presentations, and press releases)
  • Contribute to in/out licensing activities and external fund-raising activities

Your profile

  • PharmD, PhD or an equivalent degree in pharmacokinetics, pharmacology, life sciences or a related discipline with a minimum of 5 years experience in clinical pharmacology or pharmacometrics within Translational R&D
  • Excellence knowledge of GCP, GCLP, GLP and ICH guidelines
  • Knowledge of Regulatory Affairs (EMA, FDA…) is a plus
  • First experience in project management
  • Strong communication & presentation skills
  • Very good communication & influencing skills (oral and written)
  • Fluency in English (both oral and written)
  • Strong team player, looking to drive further projects and innovation

Job Features

Job CategoryCLINICAL DEVELOPMENT

Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines. Prepare, oversee, and review documents that are related to assigned clinical study.

Key responsibilities

  • Work in close collaboration with the project team and develop the clinical pharmacology scientific strategy for assigned projects in Oncology or Antibiotics
  • Manage the clinical pharmacology activities of assigned projects, by contributing to the design of clinical pharmacology studies (SAD/MAD PK, bioequivalence, food effect, drug-drug interactions, PK in special populations), planning and managing the pharmacometrics activities
  • Be a member of the Clinical Study team, contribute to the protocol writing and manage the PK and PK/PD analyses (noncompartmental analyses and modeling approaches) and reporting; manage the risk of food-drug interactions and drug-drug interactions with regard to concomitant medications.
  • Manage the outsourced activities, from provider selection until completion of project
  • Contribute and participate to scientific communication and events
  • Prepare the clinical pharmacology and pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities
  • Contribute to the In & Out licensing activities or external fund-raising activities

Your profile

  • PhD (PharmD is a plus) in Lifesciences, pharmacokinetics, clinical pharmacology, or a related discipline
  • At least 7-year experience in clinical pharmacology within Translational R&D and early clinical phases of drug development
  • Expertise in Pharmacometrics such as Non-Compartmental PK analysis, Population PK/PD, Modeling & Simulation
  • Excellence knowledge of GCP, GCLP, GLP, and relevant regulatory guidelines
  • Experience in Oncology is an asset
  • You are used in working in cross-functional team and fast-paced environment
  • Team player, looking to tackle challenges together with your team
  • Excellent communication skills in English (oral and written), French is an asset

Job Features

Job CategoryCLINICAL DEVELOPMENT

Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines. Prepare, oversee, and review documents that are related to assigned clinical study.

Abonnieren Sie unseren Newsletter

Verpassen Sie keine neuen Updates in Ihrer E-Mail

Nach oben scrollen