Sr Director, Medical Affairs MD - United Kingdom
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- 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.
- This position is responsible for providing medical support to the Company’s product development strategy and post marketing commitments, while supporting Medical Affairs strategy related to the Independent Research (IR) program.
- This individual will interface with physicians / clinical investigators, regulatory agencies and internal departments.
- The Medical Director, (MD) must possess in depth knowledge of company’s approved products, agents in the pipeline and all associated disease areas.
- This position will represent the department and company at key internal and external meetings.
- This positions responsibility may also include providing input on marketing programs and representing our company at scientific, clinical and business development meetings.
- Responsible for direct management and medical input in support of key medical messaging such as core claims documents and monograph etc.
- Responsible for the development of a Medical Affairs Plan for appropriate products or therapeutic areas.
- 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 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 within the region.
- 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 IRRC and MPRC committees
- 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
- Present at training courses, sales conferences, regional meetings, etc. to develop high level of medical knowledge within the organization.
- Travel within the EUMEA region and to the U.S. will be expected.
- Ability to work proactively and effectively, with exceptional creative problem solving skills
- Excellent presentation, written and oral communication skills required.
- MD, MBBS or equivalent
- Full GMC registration or equivalent (e.g. “Approbation”) and have the right to work in the UK.
- Industry experience, preferentially in orphan diseases.
- Clinical trial and publication experience is essential.
- Knowledgeable and current in GCP guidelines in Europe and the US.
- Demonstrate excellent medical affairs skills and ideally have working knowledge in the therapy area.
- Willingness to travel approx. 30% (also international)
- Internally, will be expected to interact on a daily basis with various members of European operations and also as required with Global Medical Affairs and colleagues in San Rafael, CA., USA.
- Externally, will be required to interact with, inter alia, KOLs and patient associations.
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- All employment offers and resumes are managed through our Human Resources Department and all candidates are presented through this avenue.
- Therefore, the Human Resources Department at company requests that recruiters are not to contact company employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with the company.
- Our company will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions.
- Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of our company.