Orchard Therapeutics
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:
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Leadership of an efficient and productive NA Medical Affairs field team by
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Fostering a team environment aligned with company values and culture
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Setting and maintaining team performance standards
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Reporting on team deliverables and team effectiveness
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Leading team identification and building of thought leader relationships
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Collating and providing therapeutic area clinical insights
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Providing regional input into global medical affairs objectives and tactics
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Participating in regional medical, legal, and regulatory (MLR) review per SOP
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Establishing and maintaining regional functional annual budget
Development and execution of NA Medical Affairs team plans for post-approval clinical programs by
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Effective HCP engagement
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Compliant HCP scientific exchange and medical education
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Support of the clinical care pathway / patient treatment
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Alignment with the regional commercial team lead and team plans
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Medical education supporting Market Access / Reimbursement
Development and execution of NA Medical Affairs team plans for late-stage investigational clinical programs by
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Effective HCP engagement
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Compliant scientific exchange and medical education
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Clinical trial awareness / recruitment / retention
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Support of the clinical care pathway / patient treatment
Foster and drive Medical Affairs efforts to:
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Build and maintain NA regional KOL healthcare provider relationships including
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Team representation at key external meetings
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Regional scientific and clinical congresses / meetings; including thought leader engagement, session coverage, and booth staffing
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Engage with healthcare providers regarding investigator-initiated studies, educational grants, and other research proposals
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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
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patient advocacy groups
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diagnostic and newborn screening partners
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clinical trial sites
Represent NA Medical Affairs region and support key internal cross-functional teams
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Medical Communications / Publications / Medical Information teams
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Product specific clinical program teams
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Regional and global operations teams
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Global internal teams (Boston, London, remote)
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Other internal forums and teams as requested
Advance projects and initiatives for Medical Excellence supporting
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Medical Affairs capabilities reinforcing value and impact
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Medical Information infrastructure, processes, and systems
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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:
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Medical Affairs function within industry
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Field Medical Affairs (medical science liaison) team roles and responsibilities
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People manager role and responsibilities
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Post-approval space Medical Affairs activities in the United States
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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:
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Medical Affairs role within the context of clinical development, product launch and life-cycle management
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Rare disease and/or neurology/genetics (neurometabolic) therapeutic landscape
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Gene therapy and/or hematopoietic stem cell transplantation (HSCT)
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Medical Affairs Medical Excellence
Skills and ability to:
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Develop internal relationships in a matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts
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Exhibit excellent leadership and strategic skills with the ability to influence decisions, both internally and externally
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Generate team results in a cross-functional setting
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Assimilate / interpret new information and inform the business
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Manage multiple projects simultaneously
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Work independently and lead teams in the execution of operational deliverables
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Identify departmental needs and partner with colleagues to proactively implement practical solutions
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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
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