Medical Director, Experimental Medicine
Location United States, Remote
Workstyle Remote Only ApplyRole Summary: Fully remote role, US based candidates only
BioMarin’s Experimental Medicine team is seekinga physician scientistto serve as a key matrixed clinical leader focused on thepreclinical planning, execution,anddesignand execution of highly informative first-in-human clinicalexperiments. Leveraging deep experience inbiomarkers andtranslational clinical research, the Medical Director will partner withPreclinical Pharmacology, Biology,Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory and Clinical Operations colleagues to ensure that BioMarin assets are optimally positioned at the time of IND filing to inform a well-designed clinical strategy. Clinical Development plans will be designed togain maximal insights during initial clinical experiences with new therapeutic agents. The Medical Director will havewidespread impactson theBioMarin earlyclinical pipeline. Key contributions will includeinformingappropriate preclinicaldata requirements prior to IND,delivery of initial clinical development plans, preIND and INDdocuments, andwell-designed clinical trial protocols and supportive documents. In addition, this role will contribute to clinical assessments of new project opportunities(both internal projects and supporting business development activities).
RESPONSIBILITIES:
- As a member of preclinical project teams, inform preclinical experimental plans for in vitro and in vivo pharmacology and toxicology packages,
- Develop biomarker strategy for preclinical assets and inform execution of experiments to inform their downstream clinical usage in advance of asset entry to the clinic.
- Formulate clinical development plans that serve as the strategic basis for full clinical development of an asset, with particular emphasis on demonstrating proof of mechanism in first in human and first in patient clinical trials as well as subsequent demonstration of proof of concept in the clinic.
- Serve as clinicaldevelopment teamleadfor assets in the research phase through Phase 1 clinical trial study completion.
- Lead clinical contributions to pre-IND and IND submissions (and other stage-appropriate Regulatory submissions)
- Leadclinical contributions to Phase 1 studyprotocols and trial- related documents.
- Design and execute natural history studies that enable (1) deepened understanding of proposed targeted patient populations and (2) development of endpoints that enable efficient demonstration of POC and/or approval.
- Serve as clinicalexpert to aid new project identification (both on internal new programs and business development opportunities).
- Represent Experimental Medicine in scientific advisory and academic meetings.
- ServeasMedicalMonitor onBioMarin clinical trials.
QUALIFICATIONS:
- MDrequired.MD/PhD preferred
- Ability to work collaboratively in a matrixed, fast-paced environment.
- Interest and curiosity in development challenges.
- Effective and impactful in cross-functional team structure.
- Excellent communication skills, with a desire to develop strong internal and external collaborations.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
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Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.