R&D - OPEN POSITIONS (based in Lugano)
Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisitions to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with long-standing partners in 190 countries, who share our values. The Group’s pharmaceutical business, (Helsinn Healthcare) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) which market the Group’s products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals, a drug product manufacturer). 3B Future Health Fund (formerly known as Helsinn Investment Fund) was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.
Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company's strategic plan by a commitment to sustainable growth. To learn more about Helsinn Group please visit www.helsinn.com
In 2021, Helsinn entered into a strategic partnership for the development and commercialization of a targeted oncology drug in a new therapeutic area and we are excited at the potential impact this could have for patients worldwide.
We are therefore looking for talented and experienced individuals that share our mission and values, in order to advance this new phase of the Company’s development pipeline.
To strengthen our R&D team in Lugano, we are looking for:
- 2 STATISTICIANS (permanent and long-term temporary contract)
Department: Statistics & Data Management
Main responsibilities: provide methodological, statistical and data management support to projects in clinical development at Helsinn. Define, plan, coordinate and monitor all activities pertaining to the management and analysis of clinical data carried out internally and/or by third parties with the goal of the product registration and maintenance of post-licensure of the product.
Requirements: minimum 5 years experience in statistics department of a pharmaceutical company or in a CRO. Previous experience with Oncology products is considered a plus. Degree in Statistics or Mathematics. Knowledge of SAS system + CDISC required. Knowledge of English language is mandatory. Analytical skills, accuracy and team work are essential for this roles.
- 2 CLINICAL OPERATIONS MANAGER (long-term temporay contracts)
Department: Clinical Operations & Services
Main responsibilities: ensure implementation and coordination of clinical trials sponsored by the Company in relation to the molecule(s) of competence, within time and costs defined in the Company’s budget.
Requirements: at least 3 years of experience in planning, conducting and managing clinical trials, including clinical monitoring, project management or similar experience gained working at a pharma company or CRO. Degree in science is required. Knowledge of English is mandatory. Analytical skills as well as strategic vision and organizational skills are required. Excellent interpersonal relation with colleagues and functions external to the company, as well as ability to work in a team and also independently.
- 1 REGULATORY DOCUMENTATION SPECIALIST (permanent contract)
Department: Regulatory Affairs & Drug Safety
Responsibilities: Support the Regulatory Digital Transformation Manager to manage the logistics, preparation, quality assurance, and delivery of global regulatory submissions in accordance with Regulatory agency requirements, company standards, and timelines. Provide ongoing daily records management support (paper and electronic) for therapeutic development projects.
Requirements: 2+ years of experience in Life Science / Pharmaceutical Sector - Regulatory Affairs Field. Life science with additional training in IT areas + profound understanding of eCTD regulatory guidance in the EU and US and knowledge in Dossier e-Submission. Knowledge in Documentation Life Cycle and Good Documentation Practices. Attention to details, flexibility and ability to work under pressure.
- 1 REGULATORY AFFAIRS MANAGER (permanent contract)
Department: Regulatory Affairs
Responsibilities: implementing the regulatory strategy of (investigational) medicinal products and Companion Diagnostics, according to Project Master Plan and company’s objectives in order to obtain the approvals worldwide. Responsible for executing and coordinating all the regulatory activities required to obtain the Marketing Authorization, according to the priorities agreed internally with the other departments involved, including Commercial and Legal departments. Manages the life-cycle of approved medicinal products worldwide
Requirements: at least 3 years in a Regulatory Affairs Manager role at Corporate level (HQ) of a Multinational Ethical Pharmaceutical Company or at least 5 years in a Regulatory role within a CRO including working knowledge of the ICH regulations (preferably US, EU) and the publishing systems for electronic submissions (eCTD). University Degree in Health Sciences and fluency in english.
- 1 MEDICAL LEAD (permanent contract)
Department: Medical Affairs
Responsibilities: is responsible for developing, supervising and managing medical affairs strategies and tactics related to the assigned compound/s and disease areas of interest within Helsinn on the basis of the existing clinical data and gaps, working collaboratively with Healthcare Professionals (HCPs), medical counterparts of business partners and internal stakeholders. the Medical lead ensures medical objective alignment at Helsinn group level for the assigned compound/s serves as a reference point for affiliates and commercial partners medical affairs activities.
Requirements: (5+) years of experience for an MD or seven plus (7+) years of experience for a PhD. At least five (5) years of prior pharmaceutical company experience ideally within the oncology area including two plus (2+) years in medical affairs. Experience with publication planning and educational programs, preferably in oncology. Experience or direct interactions with commercial teams. Possess an understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers. Fluency in English and willingness to travel frequently.
- 1 CDx EXPERT (permanent contract)
Department: Preclinical Development & DMPK
Responsibilities: embodies the company expertise on companion diagnostics and biomarkers, with particular focus on targeted oncology programs in a cross-functional setting. The incumbent provides expert diagnostics and biomarkers input in the design, implementation, analysis and reporting of (clinical/non-clinical) studies including supporting the preparation of protocols, final reports and regulatory documents.
Requirements: 5+ years of experience in a similar role in a pharmaceutical company, bioanalysis laboratory or service provider. MS in a pertinent scientific discipline, advanced degree (e.g. PhD) constitutes a plus. Very good knowledge of tissue and plasma based molecular testing, including NGS. Ability to think strategically and effective team participation skills. Fluency in English.
Helsinn is offering attractive conditions, a working environment in a dynamic, highly motivated team and a long-term perspective.