Medical Director, Clinical Science

Who We Are

Bio Marin 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.

Bio Marin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring.

The Medical Director has a key scientific and analytical leadership role in the development of CLS core deliverables across study planning, design and execution, results analysis and regulatory filings. Key focus areas include: acting as a study Medical Monitor and providing the scientific input into the creation and review of all CLS study deliverables and monitoring subject eligibility, study data and contributing critically to the scientific interpretation and integration of clinical study results.

The Medical Director will also contribute to the scientific strategy and plan as outlined in the Clinical Development Plan (CDP).

The Medical Director is also responsible for providing medical input into the creation and review of all CLS study deliverables to support clinical decision making, problem solving, safety surveillance, and collaboration with external physician stakeholders.

Scientific Leadership

• Support the definition of the core clinical and scientific strategy that serves as the basis for the CDP and provide CLS expertise in the design and execution of clinical studies under the purview of the CDP
• Participate (as assigned) in the development of CLS-assigned sections of regulatory filings and in drafting regulatory responses in collaboration with Medical Writing
• Establish relationships with investigators and KOLs as appropriate in support of the CDP

• Stay up to date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements
• Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication
• Attend and contribute to relevant scientific conferences, seminars or presentations

Clinical Study Planning and Monitoring

• Act as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk
• Initiate and provide the medical and scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions and other key study deliverables
• Provide clinical input to statistical analysis plan to ensure alignment with Regulatory and business interests
• Facilitate the review and approval of all study related CLS deliverables and content
• Act as study scientific subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues
• Provide leadership to sites by developing or participating in training, answering investigator/site questions about the protocol
• Respond to site and Health Authority questions about the protocol
• Conduct periodic review of protocol deviations in collaboration with Clinical Operations Study Lead or designee (per protocol specific Protocol Deviation Plan)
• Attend and present at Investigator Meetings, as needed
• Conduct data review,…