Head of Preclinical Drug Development, Neurology (SRJD-007)
Job ID: SRJD-007
Category: preclinical Development
Location: Basel, Switzerland
The Head of Preclinical Drug Development will be responsible for the leadership of all aspects of multiple Development Programs in Neurology including the bio-analysis, target finding, drug metabolism, pharmacokinetics, toxicology and clinical pharmacology support in regulatory filings, from the beginning of preclinical development stage through the clinical development. This individual will effectively coordinate and manage team activities tailored to address the specific needs of individual programs, and identify innovative approaches to both increase the speed with which therapies can get the IND approval and enhance the value of programs as assessed by alignment with Target Product Profiles and stakeholders in the ‘Circle of Value’. HPDD will organize CROs and individual employees in development programs and contribute to considerations with regard to balancing resources across the Development portfolio. This position will report to the Chief Scientific Officer.
- Accurate and effective budget management for Development Programs, addressing issues as they arise.
- Tracking progress against project goals and composing monthly reports for senior management and Leadership teams outlining key strategic events for projects. These documents contain program milestones, strategic imperatives, and financial information regarding projects.
- Manage department team in performing bio-analysis, target finding, drug metabolism, pharmacokinetics, toxicology and clinical pharmacology work toward supporting drug discovery, preclinical development and clinical development projects.
- As an experienced preclinical development professional, take a hands-on role in establishing a detailed preclinical development plan, possibly working with a less experienced preclinical representative in the team.
- Be the lead preclinical representative at key external business meetings (e.g. with regulatory authorities) and the lead presenter at regulatory Advisory Committee meetings.
- Line management and/or mentorship of less experienced development program leaders and/or preclinical research staffs. Developing and maintaining professional liaison with all levels of the organization
Education and Experience Requirements
- PhD Degree, preferably in Pharmacology, Drug Metabolism, Toxicology or related discipline.
- Knowledge and industry experience in pharmacokinetics, target finding, drug metabolism, bio-analysis, toxicology and clinical pharmacology.
- Experience in neurology field strongly preferred. Strong publication record on neurology and experience with external Scientific Advisory Boards preferred.
- At least 10 years of research, preclinical, development and management experience in industry or contract research organization with a minimum of 5 years in management position.
- Strong knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experienced in global drug development; Working Knowledge of GLP, GMP.
- Proven skills in building teams, supervising personnel, and completing projects
- Aware of changing trends in pharmaceutical drug development, and experience in applying new approaches
- Troubleshooting and solving problems under very challenging timelines while maintaining standards of quality. Applying strategic and business thinking, while also ensuring operational excellence.
- Requires excellent interpersonal skills including active listening, effective meeting management, negotiation, and optimizing group dynamics. Must be open to the ideas of others and utilize different perspectives to drive towards creative solutions.
- Ability for broad strategic thinking in drug development beyond just their area of technical expertise
- Excellent oral and written communication skills, Proficient computer skills.
If you are interested in this position, we are looking forward to hearing from you. Please send your CV to email@example.com.
Job ID: SRJD-008
Category: Preclinical Development
Location: Basel, Switzerland
Job Type: Part time (20%-50%)
The Research Biochemistry Expert will be a biochemical expert who is able to guide the research team on all biochemical related aspects during the preclinical stage.
- Provide advices for the drug research team on structure function relationship analysis, target finding analysis and mode of action analysis.
- Assist the drug research team on formulation, bioanalytical, cell based assays, receptor binding, cell-based toxicology and ADME studies.
- Accountable for working with the group leaders to provide expert delivery and meeting expected outcomes of technical quality, schedule, and cost.
- At least bachelor’s degree in chemistry, biochemistry or other life/physical science and at least 10 years related industrial experience OR Master’s degree chemistry, biochemistry or other life/physical science and at least 8 years’ related industrial experience.
- Strong insight to study the structures, functions and interactions of biological macromolecules including proteins, nucleic acids, carbohydrates and lipids.
- Understanding of biological and pharmaceutical principles and a working knowledge of the use of structure-based or other computer-aided drug design tools.
- Knowledge of the application of synthesis techniques to medicinal chemistry.
- Expertise in multiple analytical techniques, including: MS, GC-MS, HPLC, and FTIR/Raman/UV-visible.
- Demonstrated oral and written communication skills, teamwork, and attention to detail.
- Demonstrated ability to build and maintain effective relationships (internal and external).
- Demonstrated experience in managing or serving in technical leadership positions.
- Working knowledge of Good Laboratory Practices regulations.
If you are interested in this position, we are looking forward to hearing from you and please send your CV to firstname.lastname@example.org.