Fulcrum Therapeutics is pioneering small molecule therapeutic approaches to gene regulation in neuromuscular genetically defined diseases. The current opening is for a Director with a minimum of 10 years of Pharmaceutical / Biotech experience to lead our Toxicology function.
Essential Areas of Responsibilities
- The successful candidate will play a key role at Fulcrum Therapeutics leading the nonclinical toxicology work in support of our drug discovery programs and clinical candidates. The ideal candidate will have extensive experience with the design, execution and interpretation of in vitro and in vivo toxicology studies. The candidate will be responsible for competitive bidding/managing studies and reports with CROs to undertake these studies, and will be accountable for the review, analysis and reporting of the safety pharmacology and toxicology data. This leader will need to work across an excellent multi-disciplinary team to advance programs through the pipeline. The successful candidate will have extensive experience creating regulatory documents (INDs, CTAs, NDAs etc.) and interacting with global regulatory agencies.
- Lead the Toxicology function to design and execute phase-appropriate in vitro and in vivo toxicology studies. Responsibilities include designing, monitoring and interpretation of all types of studies necessary to support a successful regulatory approval
- Direct experience in problem solving of ADME, PK, toxicology or pathology issues; Ability to connect toxicology and pathology to ADME, PK and clinical program support
- Provide both strategic and tactical input to teams as they advance from target discovery through lead optimization to clinical development
- Interactions with regulatory agencies and health authorities worldwide
- Ability to work on multiple projects in a matrixed organizational structure
- Coordinate with collaborators and CROs to design and manage toxicology and safety pharmacology experiments.
- Strong written and oral communication to support internal and external communication of data, study reports and regulatory documentation.
- Excellent teamwork in a highly matrixed environment with ability to mentor, grow leaders and maintain focus on Fulcrum’s culture and values.
- Ph.D. (with 10+ years of drug discovery industry experience) in Toxicology or a relevant field.
- DABT certification
- Track record supporting drug discovery and development programs from target identification through commercialization with small molecule experience required (e.g., IND and NDA’s)
- Significant experience in all aspects of toxicology including general, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology (experience in conducting studies necessary for successful IND and NDA registration)
- Knowledge of GLP procedures plus FDA and ICH guidelines
- Experience authoring all types of regulatory documents and interacting with global regulatory agencies
- Extremely effective functional leader and mentor in a matrixed environment. Supports an overall group culture that is agile, proactive, collaborative, and innovative.
- Effective management of external collaborations and service providers (CROs) and ability to bring pragmatic business minded approach to balancing internal and external capabilities.
- Professionally represents the function and company more broadly in collaborations, partnership discussions, external relationships and interactions with regulatory agencies.
- Highly motivated cross-functional team player who is flexible with ability to work in a fast-paced environment. Ability to provide novel, innovative solutions to challenging problems. Possess an extremely high degree of scientific discretion, intuition and integrity.