Senior Clinical Science SpecialistLocation San Rafael, California Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Clinical Science Specialist (CSS) will work within the phenylketonuria Clinical Science group and to provide Clinical Science input for the planning and tactical execution of the clinical development plan by working collaboratively with colleagues in relevant functions such as Clinical Operations, Biometrics, Project Management, Medical Affairs, Regulatory, Research and Development, Pharmacovigilance and Pharmacology/Toxicology. The CSS may serve in various roles, not limited to membership on clinical trial teams and project sub-teams and participating in study design and medical monitoring. Our group is currently designing a variety of phase 1-4 studies for drugs such as biologics and gene therapy products.
- Design, update and implement Clinical Development Plans (CDPs), and work with Development Project Management (DPM) to ensure progression in accord with current plans and timelines.
- Provide scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports.
- Collaborate with internal departments to review analysis and reporting documents (clinical study reports [CSR], statistical analysis plans, AE report forms, et cetera).
- Partner with BioMetrics and Medical Directors to identify analyses of interests, as well as to interpret and communicate outputs.
- Help define parameters for data review, and perform medical data reviews during study execution to ensure integrity and accuracy of accruing study data.
- Collaborate with Clinical Operations, Medical Directors, and other groups to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.
- Support study teams (clinical and registry) for assigned BioMarin investigational and marketed products; serve as CLS representative and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed.
- Partner with Medical Director to assist in the development of key documents to support the components of trial execution and regulatory submission (including Investigational New Drug Annual Reports [IND], Investigator Brochures, Briefing Books and Pediatric plans; marketing authorization documents).
- Collaborate with internal stakeholders to support filing of regulatory documents.
- Engage and establish rapport with KOLs and scientific or clinical experts.
- Stay up to date with the latest thinking regarding mechanism of disease, diagnostic tests, treatment, drug development trends, and regulatory requirements in assigned disease and therapeutic areas with literature reviews.
- Collaborate with Medical Director to create and/or review slides for internal and external meetings.
- Develop therapy-specific publications plans and working with internal and external colleagues to prepare study results for timely presentations and publication.
- Work with Clinical Science and Clinical Operations to ensure the success of Investigator Meetings; specifically by contributing and presenting scientific content.
- Attend and contribute to relevant scientific conferences, seminars or presentations.
- Plan and organize visits or lectures from external experts and KOLs.
- Manage Steering Committee meetings by setting dates, defining content, building presentations, disseminating information and documents, keeping minutes, and otherwise ensuring adherence to roles and responsibilities defined in the SC charter.
- Advanced Clinical/Science Degree preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
- Medical specialty in genetics and experience in PKU and/or gene therapy desirable; sub-specialty experience in clinical trials, molecular medicine, data analysis also desirable
- At least 3 years of clinical trial experience (minimum of 2 years of clinical trial experience in industry)
- Strong computer and data analysis skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
A preferred candidate will have:
- An advanced clinical/science degree (PhD, PharmD, RD, Masters or equivalent).
- Three plus years of post-graduate clinical experience, pharmaceutical industry experience or equivalent.
- Thorough knowledge of rare disease processes from a regulatory and from a therapeutic perspective.
- Experience managing and working within cross-functional teams.
- Fluency in clinical trial design, implementation of clinical studies and medical monitoring.
- Familiarity with relevant documents and processes, including INDs, marketing application documents, pediatric investigational plans, pediatric study plan, CRFs, CSRs, protocols and administrative documents.
- Familiarity with GCP, ICH, FDA, EMEA, NICE and other relevant guidelines.
- Experience in the composition, submission and publication of scientific literature.