Senior Director Drug Safety
vor 4 Wochen
Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that efficiently accelerates the discovery and development of small molecule RNA targeting drugs by leveraging our RNA and drug development expertise and collaborations with large pharmaceutical companies. Their lead product candidate, SKY-0515, is an HTT-targeted RNA-splicing modulator currently being evaluated in a Phase 1 trial for Huntington’s disease. Location: Basel / hybrid
Your responsibilities
- Serve as Project Safety Representative on early Discovery through Phase 1 projects, including the critical evaluation, risk assessment, and communication (including authorship of FIH-enabling regulatory documents) associated with nonclinical safety data and contribution to overall program strategy
- Design, oversight, and monitoring of outsourced nonclinical safety studies for assigned projects, including interaction and communication with key CRO partners
- Responsible for target safety assessments and contributing to investigative toxicology efforts
- Scientifically assess and recommend vendors and outsource nonclinical studies to appropriate CROs
- Summarize safety studies for internal and external review and regulatory submissions
- Participate in early clinical candidate selection and asset characterization in support of clinical trials
- Assess innovative technologies in the field of toxicology and provide recommendations to advance Skyhawk’s toxicology screening strategy as appropriate
Your profile
- DVM or PhD in Pharmacology, Toxicology, and/or a related discipline
- At least 7 years of pharmaceutical Nonclinical Safety Assessment experience, including project representation through early compound development
- Board certification in the respective field (e.g., DABT or DACVP) preferred but not required
- Knowledgeable with respect to current Regulatory Guidance (e.g., ICH) pertaining to the Nonclinical Safety Assessment of research and development drug candidates
- Broad expertise in designing, interpreting, and reporting Nonclinical Safety studies across relevant disciplines (e.g., safety pharmacology, genetic toxicology, general toxicology, etc.)
- Background in pre-mRNA splicing is a plus
- Strong interpersonal and organizational skills, as well as excellent oral and written communication skills
- Motivation, creativity, collaborative spirit, and team-oriented mindset focused on problem-solving in a goal-focused manner
-
Senior Director Drug Safety
vor 1 Woche
Basel, Basel-Stadt, Schweiz Batterman Consulting Basel AG VollzeitOur clientSkyhawk is a biotechnology company in the clinical stage that is dedicated to creating innovative small molecules to impact RNA processing of disease targets, even those typically considered inaccessible, to develop treatments for challenging diseases globally. Through their advanced proprietary platform, they accelerate the discovery and...
-
Senior Director Drug Safety
vor 4 Wochen
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary...
-
Director Drug Safety
vor 1 Woche
Basel, Basel-Stadt, Schweiz Batterman Consulting Basel AG VollzeitOur client, Skyhawkis a cutting-edge biotech company that is developing innovative small molecules to target RNA processing of disease factors, even those that were once deemed impossible to treat. Their main aim is to create treatments for some of the toughest diseases in the world. They have established a sophisticated, in-house platform that speeds up the...
-
Director Drug Safety
vor 1 Monat
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Director Drug Safety
vor 1 Monat
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Director Drug Safety
vor 3 Wochen
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Director Drug Safety
vor 3 Wochen
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Director Drug Safety
vor 1 Monat
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Director Drug Safety
vor 3 Wochen
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Associate Safety Medical Director
vor 1 Monat
Basel, Schweiz BioTalent VollzeitBioTalent is collaborating with an Innovative Swiss based BioTech company in the rare disease field. We are looking to appoint an Associate Medical Director of Drug Safety in a full time capacity. This is a rare opportunity for an experienced individual to join a forward thinking and expanding company. **Offer**: - Permanent, full time position -...
-
Drug Safety Physician
vor 1 Woche
Basel, Basel-Stadt, Schweiz NES Global Deutschland GmbH NES Fircroft VollzeitWe have an exciting opportunity for a Drug Safety Physician (m/w/d) in SwitzerlandTasks You are responsible for safety aspects of marketed products, including reviewing postmarketing AE reports, signal detection, risk management, and risk minimization. Lead the Safety Management Team, ensuring integration and interpretation of safety information. Coordinate...
-
Drug Safety Case Manager
vor 3 Wochen
Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit**About Idorsia Pharmaceuticals Ltd** Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core. Headquartered in Switzerland - a European biotech hub -...
-
Drug Safety Case Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Idorsia Pharmaceuticals Ltd. VollzeitAbout Idorsia Pharmaceuticals LtdIdorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.Headquartered in Switzerland - a European biotech hub - Idorsia is...
-
Drug Safety Trainee
vor 2 Wochen
Basel, Schweiz OM Pharma Ltd. VollzeitLocation: Villars-sur-Glâne, Fribourg, CH- Division: - Division: Drug Safety- Job Type: TraineeshipOM Pharma has positioned itself as a local player in supporting students and young graduates in their first professional experiences. In this context, we are pleased to offer a 12 months paid internship, starting as soon as possible, as a **Drug Safety...
-
(Sr) Safety Scientist/associate Safety Director
vor 2 Wochen
Basel, Schweiz BioTalent Vollzeit**You will be Responsible For Activities including**: Aggregate case reporting (ICSR), aggregate report (DSUR, PSUR), signal detection/management, safety strategy, input to clinical development strategy (from safety perspective), Risk management (CCDS, IB, RMP, IND/NDA, MAA), support, presentations, publications, vendor relations **You will bring the...
-
Drug Safety Physician
vor 3 Wochen
Basel, Schweiz NES Global Deutschland GmbH NES Fircroft VollzeitWe have an exciting opportunity for a Drug Safety Physician (m/w/d) in Switzerland Tasks - You are responsible for safety aspects of marketed products, including reviewing post-marketing AE reports, signal detection, risk management, and risk minimization. - Lead the Safety Management Team, ensuring integration and interpretation of safety information. -...
-
Safety Scientist
vor 2 Monaten
Basel, Schweiz BioTalent Vollzeit**Safety Scientist**: BioTalent Basel, Switzerland BioTalent is collaborating with a global mid size pharmaceutical company to appoint a Safety Scientist within the Global Safety/Pharmacovigilance Benefit Risk team. This will be best suited to those with higher lifescience qualifications and demonstrated years industry experience in Drug...
-
Safety Scientist
vor 1 Woche
Basel, Basel-Stadt, Schweiz BioTalent VollzeitSafety Scientist: BioTalent Basel, SwitzerlandBioTalent is collaborating with a global mid size pharmaceutical company to appoint a Safety Scientist within the Global Safety/Pharmacovigilance Benefit Risk team. This will be best suited to those with higher lifescience qualifications and demonstrated years industry experience in Drug Safety/Pharmacovigilance...
-
Director, Environmental Health
vor 2 Wochen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: The Director, Environment Health & Safety (EHS) will lead the development and implementation of core technical environment, health and safety processes and standards across the Moderna organization. In this global role, you will collaborate with the corporate and site EHS teams, and partner with the business, to ensure comprehensive EHS...
-
Senior Medical Director
vor 1 Woche
Basel, Basel-Stadt, Schweiz G&H Bankensoftware AG VollzeitPOSITION SUMMARY The Senior Medical Director will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development,...
