Project Leader - CNS and Orphan Product Development
- Lugano(Ticino) - Switzerland
Full Time Job, workplace: Lugano area
We are seeking a Project Leader - CNS and Orphan Product Development for our client, an important international pharmaceutical industry based in the beautiful Lugano area.
The project planner will operates within a fast-paced, development-focused, and partnership-oriented environment. It will occasionally involve travel for attending conferences, scientific gatherings, and collaboration with external research partners and regulatory authorities. While remote work is acceptable on occasion, the majority of the role requires on-site presence or travel to partner companies. As a Project Leader, your responsibilities will encompass the leadership and management of numerous projects, spanning from in-licensing to approval and through Lifecycle Management. You will be responsible for overseeing the planning, execution, and completion of these projects, covering all aspects of R&D, regulatory compliance, and quality. This role demands strong leadership, scientific acumen, project management expertise, and the ability to foster effective collaboration across multidisciplinary teams and with external partners.
TASKS AND RESPONSIBILITIES
- Develop comprehensive project plans, incorporating timelines, milestones, and resource allocation, in alignment with the company's objectives and regulatory obligations.
- Devise strategies for the efficient and effective execution of R&D projects, taking into account scientific, technical, and business perspectives.
- Budget planning and project organization in accordance with approved budgets.
- Lead and oversee a team of scientists, researchers, and technicians, offering guidance, mentorship, and support to facilitate their professional growth and advancement.
- Cultivate a collaborative and inventive work environment, promoting teamwork and interdisciplinary cooperation within the R&D department.
- Monitor and supervise project progress, ensuring that experiments, studies, and trials adhere to established protocols and regulatory guidelines.
- Assess research data, interpret results, and make data-driven decisions to advance pharmaceutical product development.
- Ensure that all R&D activities conform to relevant regulatory standards, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), to ensure the safety, efficacy, and quality of pharmaceutical products.
- Effectively communicate project updates, milestones, and challenges to senior management and other stakeholders, delivering transparent and comprehensive reports on R&D project progress.
- Collaborate with cross-functional teams, such as regulatory affairs, manufacturing, and quality assurance, to seamlessly integrate R&D activities within broader organizational objectives.
- Identify potential risks and challenges in R&D projects, proactively formulate contingency plans, and implement risk mitigation strategies to ensure successful project completion within defined timelines and budgets.
- Stay current with the latest advancements in pharmaceutical research, technologies, and methodologies, incorporating innovative approaches into R&D projects to enhance the company's competitive edge in the pharmaceutical market.
- Cultivate a culture of continuous improvement, encouraging the implementation of best practices and fostering a dynamic R&D environment that encourages creativity and scientific excellence.
QUALIFICATIONS AND SKILLS
- A Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
- Proven experience in leading and managing pharmaceutical R&D projects, preferably in a supervisory or managerial capacity, with a strong background in CNS, Respiratory, and/or Orphan indications.
- In-depth knowledge of pharmaceutical development processes, including drug discovery, preclinical and clinical development, and regulatory requirements.
- Strong leadership and team management skills, with the ability to motivate and inspire multidisciplinary teams of researchers and scientists.
- Exceptional communication, presentation, and interpersonal skills, with the capacity to collaborate effectively with internal teams and external stakeholders.
- Proficiency in project management methodologies and tools, with a demonstrated ability to prioritize tasks, manage resources efficiently, and deliver results within strict deadlines.
- Sound understanding of regulatory guidelines, including FDA regulations, ICH guidelines, and other relevant industry standards.
- Analytical thinking, problem-solving abilities, and a strategic mindset to navigate complex scientific challenges and make informed decisions throughout the R&D process.
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