Senior / Medical Director, Medical Affairs - United States
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- Our Romany 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 Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- 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.
- 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.
- This position is responsible for providing medical support to the Company’s product development strategy and post marketing commitments, while supporting Medical Affairs strategy. This individual will interface with physicians / clinical investigators, regulatory agencies and internal departments.
- This individual must be able to support Global as well as regional responsibilities.
- The Medical Director, (MD) must be able to rapidly acquire in depth knowledge of our company's approved products, agents in the pipeline and all associated disease areas. This position will provide leadership within Medical Affairs and may represent the department at key internal and external meetings.
- This position will include providing input on marketing programs and representing our company at scientific, clinical and business development meetings.
- Provides global coordination of all Global Medical Affairs function related to a compound or disease area specific area.
- Leads the Product or Disease Area Matrix Team
- Responsible for direct management of projects and project associated personnel.
- Responsible for the development and implementation of Global/Regional Medical Plan Plan in coordination with GMAF stakeholders, RML, AML, clinical sciences (project team lead), product development (core team lead), commercial (global commercial lead) and other relevant stake holders.
- Responsible for providing medical input into development, execution and interpretation of Phase I, II, III and IV clinical protocols. This includes review of draft IR protocols, reports and manuscripts.
- Oversee clinical registries and evaluate safety issues associated with products and promotional activities for our company products in accordance with respected regulatory requirements.
- Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community.
- Responsible for direct interaction with investigators, KOLs and the research community to support company initiatives.
- Responsible for representing our company at scientific, clinical and business development meetings.
- Direct medical writing activities associated with Medical Affairs to ensure accurate execution of product dossiers, product related slide decks, standard response letters, FAQs as well as corporate abstracts, posters, oral presentation and manuscripts when appropriate.
- Promote effective communication between internal and external groups regarding Medical Affairs initiatives.
- Act as a key member of the Core team/Project team, IRRC, PRB, MMRC and MPRC reviews
- Serve 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
- 2+ years experience in pharmaceutical or biotech industries, Medical Affairs experience preferred
- Intellectual strength, analytical ability and high professional standards in designing, conducting and evaluating clinical research
- 2+ years as a medical monitor on company sponsored trials is preferred.
- Clinical trial and publication experience essential
- Knowledgeable and current in GCP guidelines in US and Canada
- 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
- 30-40% travel requirement and may include weekends
- MD with US licensure or fellowship required
- Expertise in genetic disease and metabolic diseases desired