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

Requirements

Required Knowledge Skills

Substantial and proven Medical Affairs experience in the biotechnology / pharmaceutical industryRequired 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