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Senior / Medical Director, Clinical Science - United States
Posted on : 04 April 2017
- Our company 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.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development.
- Development Sciences 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.
- Our company leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- As we enter 2015, our company will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.
- Our company has an opportunity for Medical Director (MD) with substantial clinical research and drug development experience to join a multidisciplinary clinical research and commercialization team to direct the clinical evaluation of new drugs.
- The current focus of drug development is in the rare/orphan disease area.
- The candidate, who will report to the Group Head of Clinical Science, needs to be an expert in clinical study, program design and execution.
- Experience and knowledge in interaction with clinical investigators, collaboration with regulatory affairs, and FDA interactions is required.
- BLA filing experience a great plus. Management experience preferred.
- Hands-on participation in the clinical trial development process - drives and executes clinical strategy and provides clinical expertise for the research and development project
- Serve as the Medical Monitor for clinical trial.
- Lead preparation of clinical sections of all relevant regulatory filings (IND, study reports, NDA, etc), BLA filing experience highly desired
- Interacts with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan
- Serves as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources
- Interact in collaborations with strategic partners
- Represent the company at scientific, commercial and financial community meetings and presentations, as well as other public relations opportunities
- Leads program and protocol development in general. Responsible for clinical development plans and study design of less complicated projects
- Provide input/review study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design
- Attend and provide science support for investigator and consultant meetings and other study implementation workshops
- Participates in management of studies and serves as expert on clinical and medical issues to other colleagues and study site staff
- Leads review of study data.
- Leads data interpretation and presentation to review committees and Sr Management
- Participate in the SAE report process
- Drives Clinical Science components in the writing of final study reports
- Participate in preparation for submission activities as appropriate
- Leads development of publications, abstracts, and presentations
- May be responsible for program planning and compliance with inspection readiness
- Support business development activities, including due diligence activities
- Depending on experience and interest may oversee a group of trials and/or other physicians. People management experience desirable.
- 7+ years experience in clinical functions in pharmaceutical or biotech industries.
- For appointment at the Medical Director level a minimum of 3 years experience in the pharmaceutical/Biotech industry is required
- Knowledgeable and current in GCP guidelines in US and Europe
- Be well connected within the medical and scientific community and have a proven successful track record in management
- Outstanding leadership, team, presentation, written and oral skills required
- Collaborative and flexible in personal interactions at all levels of the company
- Ability to work proactively and effectively, with exceptional creative problem solving skills
- Excellent strategic planning, organizational and communication skills
- Medical Degree required
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.