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Medical Director, Experimental Medicine

extra holidays - extra parental leave

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

MD or MD/PhD required., 5+ years of clinical trial experience., Experience leading clinical development teams., Knowledge in IND filings and Phase 1 trials..

Key responsabilities:

Formulate clinical development plans.
Lead clinical contributions to regulatory submissions.

BioMarin Pharmaceutical Inc. Research Large https://www.BioMarin.com/

1001 - 5000 Employees

See all jobs

Job description

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’s Experimental Medicine team is seeking an experienced 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 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. The 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 (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 to pre-IND and IND submissions (and other stage-appropriate Regulatory submissions)

- Lead clinical contributions to Phase 1 study protocols and trial- related documents.

- Serve as Medical Monitor on Phase 1 trials.

- 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.

QUALIFICATIONS: 

- MD or MD/PhD required.

- Significant demonstrated experience with IND filings and Phase 1 trial clinical leadership (5+ 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 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.