Executive / Senior Director, Pharmacology and Toxicology
The Pharmacology and Toxicology Department at BioMarin is seeking a Senior Director to provide nonclinical and clinical expertise regarding the development of BioMarin’s small molecule and biologic drug candidates. This individual will provide scientific leadership and play a pivotal role from late-stage research through nonclinical development for all phases of the drug development process including market application and commercialization.
A successful candidate will lead the strategic development of BioMarin nonclinical therapeutics by creating a best-evidence synthesis of existing knowledge and by designing, implementing, interpreting, investigating toxicity relationships and reporting data that elucidates the pharmacologic/toxicologic profile of drug candidates.
This individual will work collaboratively with internal and external cross-functional subteams, collaborators and consultants to map complete development pathways from research to post market application for drug candidates.
The resulting plans should result in the efficient execution of integrated nonclinical programs to support clinical development and regulatory submissions.
Studies that support BioMarin’s nonclinical programs are conducted in multiple species under non-GLP and GLP conditions depending on the objective of the studies.
Comprehensive analysis and interpretations of these studies are reported and defended to regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments and market applications.
The successful candidate will have an extensive pharmacology/toxicology background as well as a strong understanding of Good Laboratory Practices (GLPs) that will provide broad-based support to align nonclinical efforts with the company’s opportunistic philosophy of drug development.
The candidate will interact with scientists across the company in order to provide a balanced assessment as to the risk/benefit profile associated with a drug candidate’s advancement.
The individual will be responsible for the planning, implementation and organization of nonclinical studies along with the use of drug exposure to bridge across species, presentation of data (written and verbal) to cross-functional core teams and subteams, external collaborators, and the scientific community.
This individual will lead or actively participate in representing Pharmacological Sciences on cross-functional project teams and/or project subteams. This individual will also participate in program initiatives that further the business objectives of the company.
- Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development plans in support of all stages of drug development
- Design, implement, report and interpret nonclinical study data to support small molecules and biologics in late-stage research and all stages of nonclinical/clinical development
- Prepare study proposals, protocols, study reports and regulatory documents to support nonclinical development of BioMarin drug candidates
- Managerial responsibilities include supervision of Pharm/Tox scientific staff and team development
- Interact with CROs, university laboratories, analytical laboratories, collaborators, both internal and external to BioMarin, as necessary to ensure appropriate/timely progression of BioMarin nonclinical projects
- Collaborate with various BioMarin departments to ensure efficient cooperation with across functional areas
- Effectively communicate nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies (i.e. FDA, EMEA, MHRA, ROW)
- Participate in multi-disciplinary drug development teams and lead sub-teams
- Excellent written and verbal communication skills
- Ability to build and foster productive cross-functional collaborations both within and external to BioMarin.
- Prepare study synopses, protocols, study reports and regulatory documents to support nonclinical development of BioMarin’s drug candidates
- Interact/collaborate with various BioMarin functions, CROs, university or analytical laboratories, business partners, as necessary to ensure appropriate/timely progression of BioMarin projects
- A minimum of ten years of nonclinical experience in the pharmaceutical and/or biotechnology field
- A minimum of seven years of management responsibility
- Strong understanding of drug development
- Excellent written and verbal communication skills
- Ability to build and foster cross-functional collaborations both within and external to BioMarin.
- Established ability to interact with various regulatory agencies
- Established Drug Development Reputation
- Experience to support development of both small molecules and biologics
- Strong understanding of FDA and OECD Good Laboratory Practices
- Veterinarian pathology experience strongly preferred
Required: Doctorate (Ph.D.) in toxicology or closely related field of study. Board Certification in Toxicology is a plus.
AND/OR Veterinarian (D.V.M.) with Board Certification in Pathology