Exec. Director, Medical Affairs - 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.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- 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 person leads the EUMEA medical affairs (MAF) team to ensure high quality MAF managed programs are conducted with an acceptable utilization of resources.
- This position is responsible for direct management of projects and personnel within MAF in the EUMEA region.
- This position is responsible to assure consistency in process across the region for the management of MAF managed programs and budgets.
- As part of the leadership team in MAF this person is responsible for providing input for strategic direction of global as well as local programs and ensuring teams are functioning in a compliant manner.
- This person works with senior management in the development and implementation of organizational changes that will enhance programs both locally and on the global level.
- Provide leadership and direction to staff with oversight for MAF managed programs.
- 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.
- Assist in critically evaluating study results in statistical and final reports as well as 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 representing our company at scientific, clinical and business development meetings.
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources
- Ensure that staff and vendors are adequately trained to perform their functions and are following company SOPs and ICH guidelines.
- Assure proper and timely implementation of programs globally.
- Direct development of MAF managed program specific SOPs as needed and ensure they are in alignment with corporate SOPs.
- Create objectives that are in-line with corporate and global MAF goals, are measurable; facilitate effective communication so that goals are understood by MAF staff and updates to senior management are consistent and timely.
- Manage performance of direct reports – including recruiting, hiring and retention. Provide guidance to line managers so that teams are getting the guidance and training necessary for personal and program success.
- Facilitates core training and professional development for all levels of direct reports.
Provide direction and support to staff so that they become proficient in identifying and resolving problems that can affect the short- and long-term goals of EUMEA MAF.
As member of the MAF leadership team provide input into plans for new programs and company initiatives that impact global MAF.
- Develop plans to meet company-defined goals within corporate and regulatory guidelines for products both marketed and in development.
Work with senior management to develop plans for organizational change to support growth.
- Guide and facilitate organizational change/development activities. Included in this responsibility are developing communications that describe why change is needed and how change is to occur; help staff understand changes and the impact they have on their roles and responsibilities.
Develop strategic business relationships with stakeholders both internal and external.
- Medical degree is required
- Very strong Pharmaceutical experience preferred
Strong Medical Affairs experience is essential.
Previous management experience in Medical Affairs and/or Clinical Development is essential
Up to 65% travel requirement.
Experience in public presentations