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Senior Director, Medical Affairs

4 months ago

Boston, United States Orchard Therapeutics plc Full time

Reporting to: Head of Global Medical Affairs

Location: United States, ideally Boston or East Coast

Job Summary

The Senior Director, Medical Affairs will be a leadership role, accountable for Medical Affairs strategy, Medical Excellence, and field team execution for Orchard's investigational and approved hematopoietic stem cell - gene therapy (HSC-GT) clinical programs in North America (NA). This leader will work in partnership with the broader Global Medical Affairs organization and with cross-functional partners to ensure NA regional pull-though of medical strategies for supported clinical programs. This role also ensures Medical Affairs representation on cross-functional program teams, contributes to the development of integrated program strategies, and works in alignment with NA commercial team leadership. In addition to leading and managing a field-based Medical Affairs Medical Science Liaison (MSL) team of direct reports, this individual will also be an integral member of the global Medical Affairs Leadership Team (MALT). This position requires a professional with established personal and scientific credibility and self-awareness who works well in a collaborative cross-functional environment that includes Patient Advocacy, Diagnostics, Clinical Development, Regulatory, Commercial, and other functions within the broader organization.

Key Elements and Responsibilities

Responsible and accountable for:

* Leadership of an efficient and productive NA Medical Affairs field team by
* Fostering a team environment aligned with company values and culture
* Setting and maintaining team performance standards
* Reporting on team deliverables and team effectiveness
* Leading team identification and building of thought leader relationships
* Collating and providing therapeutic area clinical insights
* Providing regional input into global medical affairs objectives and tactics
* Participating in regional medical, legal, and regulatory (MLR) review per SOP
* Establishing and maintaining regional functional annual budget

Development and execution of NA Medical Affairs team plans for post-approval clinical programs by

* Effective HCP engagement
* Compliant HCP scientific exchange and medical education
* Support of the clinical care pathway / patient treatment
* Alignment with the regional commercial team lead and team plans
* Medical education supporting Market Access / Reimbursement

Development and execution of NA Medical Affairs team plans for late-stage investigational clinical programs by

* Effective HCP engagement
* Compliant scientific exchange and medical education
* Clinical trial awareness / recruitment / retention
* Support of the clinical care pathway / patient treatment

Foster and drive Medical Affairs efforts to:

* Build and maintain NA regional KOL healthcare provider relationships including
* Team representation at key external meetings
* Regional scientific and clinical congresses / meetings; including thought leader engagement, session coverage, and booth staffing
* Engage with healthcare providers regarding investigator-initiated studies, educational grants, and other research proposals
* Provide medical training and support to healthcare providers at qualified treatment centers during the treatment process

Partner cross-functionally to provide NA regional external medical education

* patient advocacy groups
* diagnostic and newborn screening partners
* clinical trial sites

Represent NA Medical Affairs region and support key internal cross-functional teams

* Medical Communications / Publications / Medical Information teams
* Product specific clinical program teams
* Regional and global operations teams
* Global internal teams (Boston, London, remote)
* Other internal forums and teams as requested

Advance projects and initiatives for Medical Excellence supporting

* Medical Affairs capabilities reinforcing value and impact
* Medical Information infrastructure, processes, and systems
* Evidence dissemination through Medical Publications & Communications

Other responsibilities as assigned