Medical Director, Experimental Medicine

Remote

Employer:

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 is a world leader in delivering therapeutics that provide significant benefit to patients who live with serious genetic diseases. BioMarin is engaged in the discovery, research, translation , and development of targeted therapies intended to correct underlying drivers of disease. We aim to provide transformational therapies in diseases of significant burden of illness and medical unmet need.

BioMarin'sExperimentalMedicineteamisseeking anexperienced Medical Director toserve as a keymatrixedclinicalleaderat BioMarinfocused onthe design and execution ofhighly informativefirst-in-human clinical experiments.Leveragingdeep experience in translational clinical research, the Medical Director willpartner with Experimental Medicine, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety,Regulatory and Clinical Operationscolleagues toensure that BioMarin assets are optimally positionedtogainmaximalinsightsduring initial clinicalexperienceswith new therapeutic agents . T heMedical Director will have widespread impacts on the BioMarin early clinical pipeline.Key contributions will include delivery of initial clinical developmentplans, preIND and IND documents, and well-designed clinical trial protocols and supportive documents.In addition, this role will contribute toclinicalassessmentsof new project opportunities (both internal projects and supporting business development activities).

RESPONSIBILITIES:

- 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 development team lead for assets in the research phase through Phase 1 clinical trial study completion.

- Lead clinical contributions topre-IND and IND submissions(and other stage-appropriate Regulatory submissions)

- Lead clinical contributions toPhase 1study protocolsandtrial-relateddocuments.

- Serve as Medical Monitor on Phase 1 trials .

- Design and execute natural history studies that enable(1)deepenedunderstanding ofproposed targetedpatient populationsand (2)development ofendpoints that enable efficient demonstration of POC and/or approval.

- Partner with Biomarker colleagues to ensurepatient selection , pharmacodynamic, response, and approval endpoint developmentplans are in place for each asset.

- Serve asclinical expert to aid new project identification (both on internal new programs and business development opportunities).

- RepresentExperimental Medicinein scientific advisory and academic meetings.

QUALIFICATIONS:

- MD or MD/PhD required .

- Significant demonstrated experience with IND filings and Phase 1trial clinical leadership (5+ years of hands-on experiencein industryclinical trials).

- Demonstrated experience in Phase 1 clinical trials in industry (within pharmaceuticaland/orbiotech companies,CROs, or Phase 1 trial units).

- Experience with Phase 2 clinical trials is preferred (and demonstration of clinical POC) .

- Experience leading clinical development teams.

- Experience with 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.

In the U.S., the salary range for this position is $ 220,000 to $ 330,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

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