Sr. Medical Director, Experimental Medicine
Hiring Manager: David Geho ([email protected])
Description
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.
Our Culture
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.
BioMarin’s Experimental Medicine team is seeking an experienced Senior Medical Director to serve as a key matrixed clinical leader at BioMarin focused on the design and execution of highly informative first-in-human clinical experiments. Leveraging deep experience in translational clinical research, the Sr Medical Director will partner with Experimental Medicine, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory and Clinical Operations colleagues to ensure that BioMarin assets are optimally positioned to gain maximal insights during initial clinical experiences with new therapeutic agents. Both an individual contributor and matrixed mentoring role, the Sr. Medical Director will have widespread impacts on the BioMarin early clinical pipeline. Key contributions will include delivery of initial clinical development plans, preIND and IND documents, and well-designed clinical trial protocols and supportive documents. In addition, this role will contribute to clinical assessments of new project opportunities.
- 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 clinical lead for assets in the research phase through Phase 1 clinical trial study completion.
- Provide matrixed leadership and mentorship to Experimental Medicine colleagues on Phase 1 trial design, implementation, and interpretation of results.
- Leverage extensive Phase 1 experience to partner with colleagues in clinical pharmacology and clinical safety to provide senior guidance on dose selection and safety monitoring for programs entering the clinic.
- Lead clinical contributions to pre-IND and IND submissions (and other stage-appropriate Regulatory submissions)
- Oversee clinical contributions to Phase 1 study protocols and trial- related documents.
- Oversee clinical execution of Phase 1 trials, with potential to oversee a portfolio of early programs.
- 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.
- Partner with Biomarker colleagues to ensure patient selection, pharmacodynamic, response, and approval endpoint development plans are in place for each asset.
- Serve as clinical expert to aid new project identification (both on internal new programs and business development opportunities).
- Represent Experimental Medicine in scientific advisory and academic meetings.
- MD or MD/PhD required.
- Significant demonstrated experience with IND filings and Phase 1 trial clinical leadership (>7 years of hands-on experience in industry clinical trials).
- Demonstrated experience in Phase 1 clinical trials in industry (within pharmaceutical and/or biotech companies, CROs, or Phase 1 trial units).
- Experience with Phase 2 clinical trials is preferred (and demonstration of clinical POC)
- Experience with development of clinical development plans.
- 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.
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.