Senior Medical Director, Clinical Science

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United States

BioMarin Pharmaceutical

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D 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 rare diseases.

Senior Medical Director, Clinical Science

 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.

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

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.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Recruitment Fraud Alert Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it’s from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov . We would also suggest you notify your local police department and monitor your credit.

For more information on how to recognize and report phishing scams visit: http[local path removed]

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.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email  Applicant_accommodations@bmrn.com  with your request.

This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team – please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at  talentacquisition@bmrn.com .

Applicants, please do not use this email address to submit resumes – if you do so, you will be redirected to apply through the website.

Click here to review “EEO Is The Law” poster .  Click here to review the Pay Transparency Nondiscrimination Statement .  Click here to review the Notification of Employee Rights under Federal Labor Laws .

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