Senior Medical Director, Clinical Science
BioMarin Pharmaceutical Inc.
Summary
BioMarin Pharmaceutical seeks a M.D./PhD with suitable background and experience in the biotech/pharma industry (or related) to join a multidisciplinary clinical research team and oversee clinical trial execution and output. The Senior Medical Director will support the global clinical development team investigating novel potential treatments. They will support the strategic development and execution of the global clinical development plan including the opportunity to participate in global regulatory filing activities. Experience with rare diseases would be advantageous.
Job description
Scope
BioMarin Pharmaceutical seeks a M.D./PhD with suitable background and experience in the biotech/pharma industry (or related) to join a multidisciplinary clinical research team and oversee clinical trial execution and output. The Senior Medical Director will support the global clinical development team investigating novel potential treatments. They will support the strategic development and execution of the global clinical development plan including the opportunity to participate in global regulatory filing activities. Experience with rare diseases would be advantageous.
Responsibilities
- Lead preparation of clinical sections of all relevant regulatory filings (IND, study reports, NDA, etc.), especially BLA filing experience highly desired
- Lead strategic planning and execution of clinical trials
- Provide clinical expertise for the research and development projects under their care; lead clinical science aspects of regulatory filings
- Serve as the Medical Monitor for clinical trials; participate in management of studies and serve as expert on clinical and medical issues to other colleagues and study site staff
- Collaborate with internal stakeholders (Project Management, Clinical Operations, Regulatory, Medical Affairs, translational science, data science, Commercial, CMC etc) to ensure successful management of the project
- Build relationships with and collaborate with investigators and key opinion leaders to ensure implementation of latest clinical thinking and guidelines into the clinical development plan
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources; participate in the pharmacovigilance reporting process
- Assist in clinical project and protocol development in general; provide ongoing medical input into study documentation, e.g. source data verification plans, case report form design etc
- Attend and provide scientific and medical support for investigator meetings
- Participate in analysis and interpretation of interim and final study data with internal colleagues and external investigators
- Participate in the writing of final study reports and lead the data dissemination plan for projects under their care; including development of publications, abstracts, and presentations; represent the company at scientific meetings
- Support other functions within the organization as appropriate; this may include business development activities, science projects
Experience
- Relevant experience in pharmaceutical/biotech or related industries. For appointment at the Senior Medical Director level a minimum of 5 years relevant experience is required
- Outstanding leadership, presentation, written and oral communication skills required
- Collaborative and flexible in interactions at all levels within the company, and with external collaborators
- Ability to work proactively and effectively, with exceptional creative problem-solving skills
- Excellent strategic planning, organizational, analytical and communication skills
- Knowledgeable and current in GCP guidelines in US and Europe; regulatory filing experience would be advantageous
- Be well connected within the medical and scientific community and have a proven successful track record
- Experience in rare diseases is desirable.
Education
MD, MD/PhD, PhD
Requirements
- MD, MD/PhD, or PhD degree
- Minimum of 5 years relevant experience in pharmaceutical/biotech or related industries
- Outstanding leadership, presentation, written and oral communication skills
- Collaborative and flexible in interactions at all levels
- Ability to work proactively and effectively with creative problem-solving skills
- Excellent strategic planning, organizational, analytical and communication skills
- Knowledgeable and current in GCP guidelines in US and Europe
- Well connected within the medical and scientific community with a proven successful track record
Company overview
BioMarin Pharmaceutical Inc. is a leading global biotechnology company headquartered in San Rafael, California, specializing in the development and commercialization of innovative therapies for rare genetic diseases. Founded in 1997, the company has established itself as a pioneer in enzyme replacement therapies (ERTs) and genetic medicine, with a focus on addressing the root causes of serious, life-threatening conditions primarily affecting children. BioMarin's portfolio includes eight commercial therapies targeting various rare disorders, including mucopolysaccharidosis, phenylketonuria (PKU), achondroplasia, and hemophilia A. The company's groundbreaking work includes being the first to provide therapeutics for mucopolysaccharidosis type I and phenylketonuria. With approximately 3,000-3,500 employees worldwide and operations across North America, Europe, Asia Pacific, and South America, BioMarin maintains a strong commitment to transforming lives through genetic discovery. The company's research and development efforts continue to advance a robust pipeline of product candidates, applying a science-driven, patient-forward approach to address broader groups of genetic disorders.