Senior Clinical Project PharmacologistLocation : Allschwil, Basel Area, BL, CHThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol : IDIA).We are excited to invite a talented and experienced Senior Clinical Pharmacologist to join our dynamic team. As a functional expert within a small, innovative group, you will play a pivotal role in advancing our clinical development programs. In this highly collaborative environment, you will provide strategic guidance on pharmacokinetics (PK), pharmacodynamics (PD), and drug interactions to ensure the successful progression of our drug pipeline. If you are passionate about making a meaningful impact and thrive in a hands-on, collaborative setting, we’d love to hear from you.Job ResponsibilitiesLeads and manages design and conduct of clinical pharmacology studies of increasing complexity, ensuring study deliverables are met on time, on budget, and with the appropriate qualityInterprets, reports, and presents study results to Life Cycle Team, Development Team, and committees comprising members of Idorsia Senior LeadershipProvides expertise to the PK / PD section of protocol of phase llb-IV studiesAuthors clinical pharmacology development plans for one or more productsAuthors modeling and simulation plans, conducting hands-on PK-PD, Pop PK-PD and related analysesParticipates in Health Authority meetings as CP representative and contributes to regulatory documents (e.g., IB, IND, Briefing Books, NDA, and other regulatory documents)Supports business development / due diligence activities as a clinical pharmacology representativeCandidate’s RequirementsMinimum PharmD degree level of education with a preference for PhD or MD level of educationAt least 10 years’ industrial experience in clinical pharmacologyProven track record of successfully representing Clinical Pharmacology in Health Authority meetingsAdvanced understanding of PK, PD, PK / PD, and / or Translational MedicineExperience in conducting and interpreting clinical pharmacology studies and translation from preclinical to clinical studiesThe ideal candidate will have experience in preparing and reviewing clinical pharmacology sections of regulatory submission documents, attending regulatory meetings as well as in developing the modeling and simulation plans and conducting PK-PD, Pop PK-PD analysesHighly self-motivated and proactive with a scientific and pragmatic approach to problem solvingA team-player with well-developed interpersonal and communication skills; able to communicate effectively within a complex matrix organization with internal stakeholders at all levels of seniority as well as external contact personsVery good English knowledge (oral / written)What Idorsia offersExciting opportunities for development and professional growth within our dynamic organizationA collaborative and solution-oriented environment where you can make a differenceAn innovative and open culture in a truly multicultural environmentA competitive salary and generous social benefitsWork Location : AllschwilCountry : SwitzerlandBusiness Area : Global Clinical Development, Clinical PharmacologySchedule : FulltimeJob Type : PermanentJob ID : 4660At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship.Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.
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