Director of Toxicology (Global)
€240000 - €280000 per annum

An international pharmaceutical company at the very start of their journey is looking to hire a new Regulatory Toxicologist to steer the scientific and toxicology support for the new therapeutics.

Other responsibilities:

* Preparation of complex Toxicological (risk & hazard) assessments of innovative botanical drugs and consumer products (determination of ADE/PDE and/or safety risk assessment) in respect to various legislations, leveraging in vitro and in vivo data and in-silico SAR approaches.

* Interpretation of in-vitro and in-vivo preclinical studies to investigate the safety pharmacology, mutagenic/genotoxic and carcinogenic properties of oral and inhalable botanical products and their components

* Planning, organisation, management and supervision of preclinical programs (including inhalation toxicity, PD/PK, genotoxicity, reproductive and embryotoxicity,) in accordance with internal and external resources, timelines, regulatory and professional standards.

* Proactive and ongoing functional area development / implementation of new methodologies and techniques.

* Active collaboration with cross-functional partners (Scientific Innovation Team , Product Development; Clinical Team, ) .Co-ordination and oversight on 3rd party service providers/CROs in preclinical toxicity and efficacy testing

To be eligible to apply you must have:

- Previous experience leading not just participating in negotiations and regulatory authorities.

- Successfully seen the life cycle of a product through to commercialisation

- Have experience leading a team but also be comfortable being the functional expert able to perform the work autonomously.

The position offers fully remote working and is looking to pay up to €280k for the right individual.

Other roles you might
be interested in:
Research Associate/RAII, Medicinal Chemistry
Redwood City, CA, USA

Research Associate, Medicinal Chemistry 100% onsite - Redwood City, CA 6mth contract (conversion opportunity available / potential of extension)   Pay rate - $28 - 38/hr    Partnering with an Oncology focused, clinical stage organization as this incredible team grows once again, following the success of other contractor conversions.   As a key member of the Medicinal Chemistry team, you will be part of an integrated, multidisciplinary research team making significant contributions toward the discovery of important new drug candidates. Your responsibilities will include: Synthesizing biologically active compounds, including the design and execution of the synthetic routes, purification of final compounds, and participating in analog design. Planning and executing assigned experiments to support research activities and project goals. Recommending experimental alternatives, researching new methods and techniques from the literature and proactively seeking out other team members to identify solutions to challenges. Presenting research findings to the Medicinal Chemistry team and management. Partnering in scientific activities with other outstanding medicinal chemists and creating an environment where all ideas are heard.   Required Experience, Skills, and Education: B.S. degree in Chemistry with 0-2 years of industry experience, or an M.S. in Chemistry with a focus on organic synthesis, the total synthesis of natural products, and/or methodology development. Experience in designing, executing and troubleshooting synthetic procedures and synthesis routes.   Preferred background: Experience with organic synthesis analytical techniques (NMR, HPLC, mass spectrometry) A strong mechanistic understanding of organic chemistry Experience with synthetic planning databases (i.e. SciFinder and Reaxys)

Director, Clinical Pharmacology
Boston, MA, USA

Overview A top mid-sized biopharma company out of the Boston area is hiring for a Director of Clinical Pharmacology. This position is can provide remote flexibility. This company is global biotechnology company with multiple commercialized drug products in the U.S and a great reputation in the space. This company operates in a few different therapeutic areas and requires a senior member to join their clinical pharmacology team and lead strategic decision making to develop their clinical pipeline. You will be acting as a SME in clinical pharmacology working with internal and external teams. You will be using the model informed drug development paradigm to facilitate drug development. As well as providing input to all applicable clinical development plans, protocols, and clinical study reports. You will work on regulatory submissions and represent Clinical Pharmacology at meetings with regulatory agencies. This individual will also help develop strategy to streamline processes in the Clinical Pharmacology group. What would you be doing? Serve as a Clinical Pharmacology SME for early development and late stage clinical projects. Provide guidance on lead modalities and programs to various teams working to determine the right target, molecule, dose, patient population and strategies. Apply knowledge in PKPD and relevant analysis (experience reviewing datasets in R or NONMEM is a plus) to strategize and predict exposure-response as well as dosing. Working closely with multiple different cross functional teams such as PMX to develop study protocols (Phase I – III). Advise on various regulatory documents (INDs, IBs, CDTs). Collaborate with various regulatory agencies (FDA, EMA, PMDA). Requirements: PhD required in pharmaceutical sciences, pharmacology, or related field At least 8+ years in the biotechnology or pharmaceutical industry Experience with clinical pharmacology and PKPD modeling, exposure-response or dose selection Experience with clinical PK data and data analysis (Phase I-IV) Experience in NONMEM and/or R (nice to have) Excellent communication skills


Need more help? Reach out<br></br> to one of our team.

We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.