高级医疗总监（临床科学）

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.

enior Medical Director, Clinical Science (Neuromuscular Disease)
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.
Originally posted on Himalayas