Senior Director, Medical Affairs

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 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