Medical Director, Clinical Sciences

Job Description
Description BioMarin Pharmaceutical seeks a medically-trained clinical scientist with expertise in clinical research and drug development to join a multidisciplinary team involved in development of novel therapeutics for rare/orphan diseases. The candidate should be proficient in clinical study design, and execution and analysis of results. Experience interacting with clinical investigators, FDA and other regulatory authorities is highly desired.

RESPONSIBILITIES


1. Hands-on participation in the clinical trial development process - conceive and execute clinical strategy and provide clinical expertise in all phases of development from pre-IND to Phase 4

2. Lead preparation of clinical sections of all relevant regulatory filings (BLA, EU Marketing application, IND, study reports, NDA, etc)

3. Participate in management of studies and serve as expert on clinical and medical issues to internal colleagues and study site staff

4. Take leadership role in review and analysis of study data and writing of study reports (CSRs)

5. Lead preparation of responses to regulatory agency queries (RTQ) and participate in FDA pre-marketing authorization meetings, EMA Scientific Advice meetings and other regulatory agency meetings

6. Attend and provide clinical/scientific support for investigator and consultant meetings

7. Assist in writing and preparing publications, abstracts and presentations

8. Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan

9. Serve as medical/scientific resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources

10. Interact in collaborations with strategic partners

11. Represent the company at scientific, commercial and financial community meetings and presentations

12. Serve as the Medical Monitor and Leader for clinical trials

13. Provide input/review study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design

14. Contribute to planning and compliance with inspection readiness

15. Support business development activities, including due diligence activities

16. Interact with research/discovery to review and identify lead candidate molecules for Clinical Development

EDUCATION

MD or MD/PhD
Post-graduate training/experience essential (i.e., U.S. internship/residency, (board-eligible as a minimum), or fellowship,)

EXPERIENCE

1. For appointment at the Medical Director level a minimum of 5 years experience in the pharmaceutical/Biotech industry is required

2. For appointment at the Associate Medical level; 3+ years experience in clinical functions in pharmaceutical or biotech industries.

4. Knowledgeable and current in GCP guidelines in US and Europe

5. Be well connected within the medical and scientific community and have a proven successful track record in management of clinical trials

6. Outstanding leadership, team, presentation, written and oral skills required

7. Collaborative and flexible in personal interactions at all levels of the company

8. Ability to work proactively and effectively, with exceptional creative problem solving skills

9. Works well with project teams and the respective functions, in particular Regulatory Affairs, Clinical Operations, Biometrics, but also Project Management, Research, Clinical Pharmacology and Commercial.

10. A strong interest in rare diseases that frequently requires creative thinking with regards to study design, endpoint selection or data analysis.

11. Experience in one or the following therapeutic areas would be considered advantageous: endocrinology, neurology, pediatrics, allergy/immunology

Company

Biomarin Pharmaceutical Inc

Job Code

State or Province

California

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