Executive Director, Pharmacological Sciences
Location: San Rafael
Posted on: February 24, 2021
Executive Director, Pharmacological Sciences BioMarin is the
world leader in delivering therapeutics that provide meaningful
advances to patients who live with serious and life-threatening
rare genetic diseases. We target diseases that lack effective
therapies and affect relatively small numbers of patients, many of
whom are children. These conditions are often inherited, difficult
to diagnose, progressively debilitating and have few, if any,
treatment options. BioMarin will continue to focus on advancing
therapies that are the first or best of their kind.
BioMarin's--Research & Early Development (RED) group is responsible
for progressing candidates from discovery into clinical
development. Research & Early Development involves all non-clinical
and clinical bench research and the associated groups that support
the data interpretation. Our teams work on developing
first-in-class and best-in-class therapeutics that provide
meaningful advances to patients who live with rare diseases. Come
join our team and make a meaningful impact on patients'
lives.SUMMARYBioMarin is seeking a seasoned, Senior Director-level
toxicologist to lead our Pharmacological Sciences Department within
the Translational Sciences Division. This individual will be
responsible for the oversight of toxicology, safety and large
animal pharmacology studies needed to support the development of
gene therapies, biologics, small molecules, and anti-sense
oligonucleotides. As head of the Pharm. Sci. function, this leader
will be accountable for the design, implementation and
interpretation of studies demonstrating the
pharmacological/toxicological profile of drug candidates. These
studies will coordinate investigations across multiple species
under appropriate non-GLP or GLP regulations and the role will
include some Test Site Management responsibilities. The leader will
have a proven track record for defending strategy to senior
executives and coordinating studies to support applications and
registrations, as well as represent the function at interactions
with global health authorities.The Head of Pharmacological Sciences
will be expected to lead by example and interact collaboratively
with scientists and department heads across Research and Clinical
Development to inform a balanced risk/benefit profile for all drug
candidates. A successful candidate will be a person who actively
seeks feedback, adapts quickly to emerging information, looks for
opportunity to make an impact, and has a philosophy of perpetual
improvement. As a department head this person will join the
Translational Sciences Leadership Team and is expected to help
unite Translational Sciences departments to drive toward a common
- Lead a group of Bachelors-to-PhD level scientists in providing
comprehensive non-clinical safety and pharmacology strategies to
support development of BioMarin drug candidates. Support career
development opportunities for staff to maintain and expand
- Oversee the design, implementation, interpretation, and
communication of non-clinical study data supporting benefit/risk
assessments across programs.
- Review study proposals, protocols, and study reports to support
non-clinical development of pipeline assets, mindful of 3R
- Supervise the authoring and reporting of non-clinical sections
for IND/CTAs, BLA/MAAs, annual reports, Investigator Brochures, and
any related incoming inquiries from health authorities.
- Leverage CROs, university collaborators, and external network
to progress non-clinical programs according to timelines.
- Ensure the appropriate use of Good Laboratory Practices for
in-life and pathology/histology portions of studies and ensure the
proper training of involved staff.
- Effectively communicate non-clinical findings and their
relevance to senior management, project teams, collaborators, and
regulatory agencies (i.e. FDA, EMA, MHRA, ROW).
- Build connections between Pharm. Sci. and other groups to
foster collaborative, productive and integrated
- At least 12 years of toxicology experience in the
pharmaceutical and/or biotechnology field including oversight of
- Multiple IND/CTA submissions for small molecules and biologics
and experience with NDA/BLA/MAA submissions.
- Established external reputation with global health authority
reviewers with track record of approved drugs.
- Deep expertise with interpretation and application of guidances
and ICH standards.
- Strong understanding of FDA and OECD Good Laboratory
- Excellent verbal and written communication skills with ability
to cogently prepare and present data in group settings, prepare
formal reports, give and receive useful feedback.EDUCATION:
- Required: Doctorate (Ph.D.) in toxicology or closely related
field of study with Board Certification in Toxicology.
- AND/OR Veterinarian (D.V.M.) with Board Certification in
PathologyWe are an equal opportunity employer and all qualified
applicants will receive consideration for employment without regard
to race, color, religion, gender, gender identity, sexual
orientation, national origin, disability status, protected veteran
status, or any other characteristic protected by law. Be the first
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- The list has BioMarin ranked #4 in America and #1 in the "Drug
& Biotechnology Industry" We are an equal opportunity employer and
all qualified applicants will receive consideration for employment
without regard to race, color, religion, gender, gender identity,
sexual orientation, national origin, disability status, protected
veteran status, or any other characteristic protected by law. If
you have a disability and believe you need a reasonable
accommodation in order to search for a job opening or apply for a
position, email Applicant_accommodations@bmrn.com with your
This email address is not for general employment inquiries or
correspondence. We will only respond to those requests that are
related to the accessibility of the online application system due
to a disability.
Keywords: BIOMARIN, San Rafael , Executive Director, Pharmacological Sciences, Executive , San Rafael, California
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