Director Clinical Pharmacology
vor 4 Wochen
**Company Description**
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
**Key Responsibilities/Scope of the Job**
Including but not limited to the following:
- Overall accountability for clinical pharmacology strategies and activities in appointed clinical projects.
- Provide matrix leadership to collaborate, align and influence across the cross-functional teams to identify and mitigate key project issues related to the clinical pharmacology discipline (PK, PK/PD, metabolism, including modeling and simulation[M&S])
- Provide expert knowledge in clinical pharmacology and clinical PK to the projects and communicate clinical pharmacology and clinical PK aspects internally and during health authority interactions.
- Define appropriate strategies for clinical pharmacology/translational medicine, clinical PK, PK/PD and M&S in clinical development plans.
- Oversee that Model Based Drug Development (MBDD) is applied in clinical programs when clinically relevant.
- Ensure translational aspects are taken into account and that pre-clinical and clinical PK/PD information are optimally used and integrated into early and late phase development plans.
- Contribute and decide on the biomarker strategy in clinical programs.
- Contribute to the clinical development plan.
- Responsible for clinical pharmacology sections in regulatory documents and at interactions with regulatory authorities during all phases of drug development.
- Represent clinical pharmacology on project Core Teams.
- Contribute to clinical pharmacology evaluations at in-licensing and due-diligence activities.
**Qualifications**
- Ph.D. in relevant scientific area
- 8 years of experience in clinical pharmacology research (preferably in the pharmaceutical industry) or a minimum of Master´s degree in relevant scientific area with 10 years of experience in clinical pharmacology research (preferably in the pharmaceutical industry).
- Profound knowledge in pharmacokinetic (PK) and pharmacodynamic (PD) concept and its integration into decision making processes.
- Strong knowledge of state-of-the-art PK and PK/PD modelling and simulation techniques.
- Hands-on experience with PK/PD analysis and modeling software, i.e. Phoenix or equivalent.
- Hands-on experience with Nonlinear mixed effects modelling and modelling software e.g. NONMEM and R is a plus.
- Solid understanding of the drug-development process and issues specific to clinical pharmacology of biotechnology products.
- Experience with biologics and small molecules is required
- Strong knowledge of regulatory requirements and experience in regulatory submissions and interactions including preparation of relevant documents for interaction with regulatory authorities with regards to clinical pharmacology issues.
- Excellent communication and presentation skills - Fluency in written and spoken English.
- Energetic, driven and able to take initiative with a “can-do attitude”.
- Results and delivery focused as well as a structured way of working.
- Good problem-solving ability and analytical mindset.
- Open, flexible, interested in colleague´s perspectives, a team player.
- Strong sense of personal accountability working independently as well as a strong ability to work in teams.
**Additional Information** Personal Attributes**
- _Excellent organizational skills, accurate and reliable_
- _ Excellent interpersonal skills_
- _ Pro-active and independent work attitude_
- _ Teamplayer, collaborative_
- _ Ability to multi-task effectively and prioritize workload_
- _ Communication style that allows positive and open dialogue with clients and empoloyees_
- In addition, you should live up to our core values: Ambition, Ownership, Urgency, Partnership and Care._
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