• Leading, in collaboration with Management, the process to establish product strategy, leading TPP creation and defining key inflection points
• Ensuring strategic and operational alignment: defining and ensuring that development plan is aligned with strategy and supports achievement of project goals and inflection points in the most efficient way.
• Planning and execution: responsible for definition of deliverables, making sure project plan is aligned with project KPIs. Monitoring key milestones, adjusting plans, if necessary, in order to deliver on schedule with the allocated budget.
• Risk management: ensuring that the risks are identified on time and that the contingency plans are in place and are communicated to the stakeholders on time to give them time to react.
• Team effectiveness: managing project team interactions, ensuring smooth communication, leading the project meetings, leading efforts in problem solving and driving the team to give their best.
• Communication: effective communication about the project within the company and in external forums.

Requirements

• MD or PhD – a must
• 5+ years of experience in leading product development in the Pharmaceutical or Biotech industries. Experience with combination products is an advantage.
• Understanding of drug product development aspects (from CMC to preclinical, clinical, Regulatory and launch preparation aspects.)
• Fluent English
• Creative problem solving.
• Strong communication and leadership skills

• Design of the phase 1 study (synopsis) to support project development
• Support CRO selection process for Phase-I studies
• Lead and manage the study planning activities
• Be a point of contact between the CRO and Clexio team
• Lead the review and finalization of study-related documents (Protocol, ICF, CRF, etc.)
• Manage communication and overall execution of the study according to the study plan until completion, in line with regulatory requirements and internal guidance
• Manage CRO and any external service providers that are involved in the phase 1 study
• Together with the CRO and Clexio’s project team, ensure that the study is in accordance with predetermined/set timelines & budget
• Thorough review of the study data (review data listings, eligibility of subjects, safety results, etc.)
• Upon study closure: leading the review of Clinical Study Report (CSR)

Requirements

• Master’s degree in Chemistry or related discipline
• 3+ years in the pharmaceutical industry focusing on analytical laboratory activities associated with new project development, commercial manufacturing and tech transfer activities
• Experience in characterization of sustained release oral dosage forms (advantage)
• Hands-on knowledge of analytical / laboratory testing including chromatographic methods and dissolution (must), analytical method development and validation
• Thorough understanding of and familiarity with the current analytical methods used for API and drug products
• Experience in product development and working in accordance with GLP and GMP requirements
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists, with minimal guidance
• Proficiency in instrumental Data Stations and Microsoft Office Suite
• Strong oral and written communication skills, in English

• Reports to Head of Clinical Operations

• Manage and oversee the operational aspects of global clinical trials.
• Responsible for the successful execution of global clinical trials from the protocol through the clinical study report, ensuring completion of study deliverables and adherence to budget.
• Responsible for the CRO selection process and to provide an oversight of the CRO and other third party vendors on assigned study.
• Regularly interact with the clinical sites to ensure engagement, good study progress and quality of the data.

Requirements

• BA in nursing or life sciences

• At least 3 years of experience as CTM or Senior CRA from Pharma, CRO or Biotech with experience in global clinical trials and clinical development.

• Strong operational management with attention to detail

• Strong knowledge of GCP/ICH guidelines

• Excellent communication skills in English (oral and written)

• Great interpersonal skills

• Available to travel (if COVID-19 situation permits)

come join us