Career

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

Key responsibilities

• Design, plan, manage, and report the nonclinical DMPK studies:
  • Exploratory DMPK studies to support innovation projects
  • In vitro and in vivo DMPK profiling to support lead optimisation and selection of drug development candidates
  • In vitro and in vivo DMPK (including toxicokinetics) regulatory and nonregulatory studies to characterise the ADME properties and the risk of drug-drug interactions of drugs in the development
  • Modelling and simulation of nonclinical data (such as allometric scaling, PBPK modelling, nonclinical PK/PD) to support human dose prediction
• Manage outsourcing activities to an international network of CROs or through academic collaborations (request for proposal, contractor selection, contract review, and budget negotiation)
• Manage finance, budget, and timelines related to assigned nonclinical DMPK activities
• Contribute to the preparation of the nonclinical DMPK documentation to support the cross-functional activities (including nonclinical DMPK chapters of regulatory documents or patents)
• Participate in external scientific communications (publications, poster, and oral presentations, and press releases)
• Contribute to in/out-licensing activities and external fund-raising activities (evaluation of new external opportunities, participation in due diligence and grant applications)

Your profile

• PhD, engineer degree or equivalent in pharmacokinetics, pharmacology, life sciences, or a related discipline with 5-7 years experience in nonclinical DMPK within Translational R&D
• Knowledge of GLP and ICH guidelines; animal welfare regulations
• Fluency in English (both oral and written)
• Very good communication skills & influencing skills (oral and written)
• Strong team player, looking to drive further projects and innovation
• Project management experience
• Team management and leadership experience is a plus

Key responsibilities

• Establish and maintain excellent relationships between our company and Heads of Business Development, CEOs, Research and Commercial Heads, of outside companies and leading university scientists to position The company as a credible in- and outlicensing partner.
• Collaborates cross-functionally with key stakeholders (Commercial, Search & Evaluation, Project Management, Research & Development, Finance, Legal and Management) in building sustainable partnering strategies for current and upcoming pipeline assets.

Out-Licensing

• Develop and maintain a solid, active and trustworthy network of potential pharma partners, through a thorough understanding of their portfolio strategies and evolution.
• Create on going visibility and interest in the company’s portfolio by strongly positioning the company portfolio to secure successful out-licensing deals.
• Drive the cross-functional efforts for the screening and sourcing of potential commercial partners, the identification and engagement with key decision makers, the due diligence process, the negotiations and conclusion of transactions.
• Lead the building of a solid business frame and seek internal approval from Leadership team, CEO and Board to conduct successful negotiations with prospective partners and secure deal closure.
• Lead the development of deal structure and support their presentation to the company governance boards as appropriate, be responsible both for progressing, closing and terminating transactions.
• Ensure that the company is regarded as partner of choice by third parties in contributing to build a state-of-the-art corporate, business and medical communication momentum.
• Represent the company in selected conferences and industry functions (such as BIO, JP Morgan, and other key partnering conferences).

In-Licensing

• Be the “project owner” in regard to in-licensing opportunities, participate in due diligence and lead the negotiation processes opportunities, in close collaboration with the Search & Evaluation representatives.
• Together with relevant internal functions, seek out and generate data required to build robust business cases that are aligned with insights generated during the due diligence
• Create, own and present content for investment opportunities to the leadership team and executive committee, and present ongoing updates.
• Ensure a smooth transition of business opportunities to operational activities once a deal is closed, in close collaboration with Program Management from the due diligence, to the asset transfer.

Your profile

• PhD (or Master) in Life Sciences, MBA a plus
• 10 years of experience in Business Development, with a solid oncology knowledge and network strongly preferred.
• Measurable Track record in negotiating and closing multiple value-creation licensing deals (out- and in-) in the biopharmaceutical industry, with a strong focus on early development transactions (up to Ph. II). Must have a strong deal sheet (applications without a deal sheet will not be considered).
• Expert understanding of key principles of contracts, deal structures, intellectual property, value drivers and valuation principles of relevance for licensing, collaboration and related
• Has developed a strong network amongst Heads of Business Development, CEOs, Research & Commercial Heads in the Pharmaceutical, Biopharmaceutical, and Biotech Industry as well as in Academic research centers.
• Strong ability to build and nurture relationships with multiple external and internal
• Expert analytical skills and ability to effectively understand and act on complex information under high time pressure situations
• Excellent communication and team player skills, including in situations of very high pressure, with the ability to lead cross-functional teams
• Outstanding ability to multitask and pre-empt future situations including at times of high pressure
• Gravitas and significant leadership and influencing skills
• Expert project management experience and track record of proactive initiation of projects
• Significant track record in terms of independently leading and transacting major complex deals
• Strong judgement and decision-making skills in order to take responsibility both for progressing, closing and terminating transactions.
• Solution and results oriented, looking for “Win-win” solutions, able to be creative to solve problems in order to achieve major objectives of parties involved.
• Proactive, self-driven, and well structured, able to work in a rapidly shifting, fast-paced
• Excellent command of English, good command of French strongly preferred

Key responsibilities

• Select, recruit, develop, manage, motivate, coach, and appraise the performance of direct reports to ensure high-quality results and support career progression through quality development plans
• Manage workload and ensure the proper allocation of resources to studies to meet company objectives and priorities, in alignment with COMs and/or COD
• Build and establish a strong team spirit, promote and nurture a professional, collaborative and positive environment for CTAs to ensure effective team working and provide professional leadership
• Facilitate and ensure effective communication between CTAs by organizing regular CTA team meetings to share experience, strategy, and working tools
• Set together with reports the annual individual objectives, follow up on the advancement of the objectives’ achievement, support reports in reaching the goals and evaluate the individual performances along the year, provide regular feedback and coaching to ensure objectives completion
• Provide leadership, operational expertise, and guidance as a point of escalation for CTA-related tasks or Clinical Operations coordination issues and identify areas for improvement
• Develop the level of support to the internal stakeholders (e.g., COD, CTMs) while improving efficiency and standardization (activities, responsibilities, tools, communication…), ensuring high-quality standards are met, in compliance with processes and regulatory requirements
• In collaboration with the Senior CTAs, ensures an optimal onboarding of newcomer CTAs and develops CTAs competencies and expertise (Subject Matter Experts).
• Encourage and develop ClinOps Innovation in terms of process and tools.

Your profile

• University/College degree level or equivalent in a relevant discipline (Science, Clinical Trial Management)
• Minimum 4 years of experience in Line management in Clinical Operations department
• Minimum 5-6 years of comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirements, and good knowledge of drug development process and medical terminology
• Be a leader and serve as a true role model / Ability to set challenging and realistic goals and to think out of the box
• You serve as a role model, willingness to coach and mentor, able to set challenging and realistic goals
• Good Interpersonal skills and communication skills (empathy and emotional intelligence)
• Ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization
• Team spirit and strong service orientation
• Strong organizational skills with ability to manage stress, pressure, and deadlines
• Excellent spoken and written English; French is an advantage
• Intermediate to advanced computer skills, mainly electronic TMF systems (Veeva Vault being as asset), including Microsoft Office applications and Adobe Acrobat

Key responsibilities

• 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
• Review and approve invoices being presented by study vendors and external consultants
• Oversight and management of CRO
• Help in the training and development of clinical staff as at when due
• Lead the clinical project team and various study team meetings
• Oversee the pattern and manner in which clinical research study is being conducted
• Fully involved in resolving issues; take part in procedure improvement initiatives
• Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
• Work together with clinical trial managers and document control personnel to manage documents that are related to the clinical study.

Your profile

• Must possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants
• Good problem-solving, organizational, and leadership skills are highly required
• Ability to work with little or no supervision
• Ability to pay attention to detail at all times
• Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
• Must be able to work as part of a team or in most cases lead a team
• Must have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline
• Ability to organize and motivate other members of the study team
• A Bachelor’s and/or a Master’s degree in any science or health-related field
• A minimum of 12 years experience in the field of clinical research of which 5 years must have been in a project lead role
• Proficient user of MS Office applications for the execution of daily project operations

Key responsibilities

• Represent the Pharmacology and Screening function in Clinical Study teams, Translational Medicine, and Global Project Teams
• Design, plan, manage and report microbiology and pharmacology studies:
  • In vitro/in vivo compounds selection and profiling, including off target characterization
  • Proof of concept in vivo studies – PK/PD
  • Mechanism of action and resistance studies
• Identify and lead method development/validation and analyses of clinical isolates and pharmacodynamic clinical biomarkers / Contributes to the development of ASTs in line with EUCAST and CLSI requirements
• Determine, implement, and manage the clinical microbiology analyses, data analyses and reporting according to GCPs and GCLPs
• Manage outsourcing activities to an international network of CROs
• Manage external collaborations with KOLs and universities
• Input the elaboration of the clinical development strategy
• Contribute to the preparation of the pharmacology and clinical documentation required for Health Authorities submissions
• Participate in external scientific communications and represent the organization during international scientific events
• Contribute to in/out licensing activities and internal innovation pipeline

Your profile

• PhD in the field of microbiology
• 5-7 years experience in translational research and antibiotics R&D in pharma or biotech
• Knowledge of GCP and ICH guidelines, animal welfare regulations, and relevant regulatory guidelines
• Excellent communication skills (oral and written) in English
• You are used in working in cross-functional team and fast-paced environment and are a team player, looking to tackle challenges together with your team
• Experience in Oncology would be a plus

Key responsibilities

• Author and review clinical and regulatory documents such as Study Protocols, ICFs, CSRs, IBs, Paediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, and responses to Health Authorities; the documents should be accurate, suited for the intended audience and easy to read
• Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements
• Drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development)
• Develop the strategy for document preparation and the document review processes: you collaborate closely with the teams to better understand the needs, the planning, and timelines & facilitate document review meetings and discussions
• Provide advice in the development and implementation of best practices in medical writing
• Trigger annual IB reviews and updates
• Collaborate closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review processes, incorporate editorial comments, and solve queries to present a 'finished' final document within the required deadline
• Ensure understanding and implementation of international quality standards (ICH GCP) and internal company procedures
• Facilitate document review meetings and discussions
• Contribute to the development of project timelines

Your profile

• Master's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, etc.).
• 5 years experience supporting the development of Study Protocols, Protocol Amendments, Briefing Books, IBs, CSRs or ICFs in Pharmaceuticals
• Strong experience of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents
• Strong working knowledge of the clinical drug development process, clinical trial design and biostatistics
• Strong experience integrating information into clinical and regulatory documents
• Fluency in English and solid writing/editorial skills
• Ability to prioritize and manage multiple demands and projects within deadline
• Good command of MS Word
• Good presentation skills and ability to interpret and present data in a logical manner
• Self-starter, flexible in adapting to changing circumstances or new information, able to adapt quickly in a fast-moving environment.
• Attention to detail, accuracy, and logical organization. Expert grammatical and communication skills, both written and oral

Key responsibilities

• Develop a clinical strategy and design a protocol for the product, taking into account current medical practice, regulatory requirements, business needs as well as the competitive environment
• Be an integral member of the development team and work closely with Clinical Operations, Biostatisticians, Drug Safety, Regulatory Affairs, and Business functions
• Provide functional leadership to the Clinical Scientist assigned to the program with respect to monitoring, reviewing, and interpreting patient profiles, safety and efficacy data of a study on an ongoing basis and assure the completeness and quality of the data
• Responsible for the updating of the Clinical Development Plan with respect to study-related activities
• Consult with internal and external experts for the generation of an innovative and optimal designed clinical program and Clinical Trial Protocol
• Deliver and execute a clinical development plan 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
• Provide guidance and support to the clinical study team with respect to identifying lead investigator(s) and high-quality investigational sites and the organization of Investigator Meetings
• Act as a medical expert for clinical study teams, CRO's, study sites, and others
• Develop and consolidate a network of Key Opinion Leaders /investigators, participate in medical congresses and symposia, and take the lead in the organization of Scientific Advisory Boards.
• Develop the scientific communication plan and supervise the development and delivery of scientific publications and scientific presentations to internal and external stakeholders
• Provide medical expertise for interactions with Regulatory Authorities worldwide
• Provide leadership to ensure the successful delivery of the clinical program, proactive identification and mitigation of risks, elaboration of contingency scenarios, swift handling, and resolution of issues and uncertainties, execution of the program to the highest scientific and GCP quality standards

Your profile

• Medical Doctor with clinical experience in oncology (solid tumours)
• Evidence of keeping up to date with the recent development in clinical practice and scientific progress
• Successful and solid experience in pharmaceutical drug development (phase I-II) of at least 5 years, with a proven track record in having led at least one oncology development program through different stages of development
• Open-mindedness, flexible, with a high level of scientific/medical curiosity
• Being able to deal with uncertainty, manage risks and drive a proper decision making
• Strategic thinking and innovative mindset, 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
• Ability to travel (20-30%)

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
• 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.
• 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
• 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 of 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
• Ability 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