Reporting to: Head of Global Medical AffairsLocation: United States, ideally Boston or East CoastJob SummaryThe 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 ResponsibilitiesResponsible 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 assignedRequirementsRequired Knowledge & Skills
Substantial and proven Medical Affairs experience in the biotechnology / pharmaceutical industry
Required to possess thorough understanding of and experience with:
Medical Affairs function within industry
Field Medical Affairs (medical science liaison) team roles and responsibilities
People manager role and responsibilities
Post-approval space Medical Affairs activities in the United States
Government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange, communication, and compliance with customers
Preferred experience with one or more key therapeutic areas:
Medical Affairs role within the context of clinical development, product launch and life-cycle management
Rare disease and/or neurology/genetics (neurometabolic) therapeutic landscape
Gene therapy and/or hematopoietic stem cell transplantation (HSCT)
Medical Affairs Medical Excellence
Skills and ability to:
Develop internal relationships in a matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts
Exhibit excellent leadership and strategic skills with the ability to influence decisions, both internally and externally
Generate team results in a cross-functional setting
Assimilate / interpret new information and inform the business
Manage multiple projects simultaneously
Work independently and lead teams in the execution of operational deliverables
Identify departmental needs and partner with colleagues to proactively implement practical solutions
Travel frequently (75%) and often overnight, to headquarters office, meetings, trainings, conferences, programs, etc. as required
Education· Advanced Scientific / Healthcare Degree (PhD, PharmD, MD, NP, DVM, or similar)· Fluency in both spoken and written English