Head of US Field Medical
Waltham, MA - USA
Job Summary
Head of US Field Medical
The Head of US Field Medical will build and lead Skyhawks US field medical organization in support of SKY-0515 and future pipeline assets with direct accountability for field medical strategy scientific engagement insight generation Medical Science Liasion (MSL) team development and management and launch readiness.
This is a hands-on builder role. The successful candidate will have experience establishing or scaling a field medical organization and leading an MSL team through the pre-launch and launch phases of at least one orphan rare disease neurology or other high-touch specialty product. The individual must be comfortable operating with the resourcing pace and ambiguity of a small biopharmaceutical company not simply directing processes developed by larger organizations.
This role sits at the center of Skyhawks Medical Affairs organization and requires close day-to-day collaboration with Clinical Development Clinical Operations Scientific Communications Publications Medical Information HEOR and Real-World Evidence Patient Advocacy Regulatory Drug Safety Legal and Compliance and appropriate Commercial partners.
Responsibilities
US Field Medical Strategy and Leadership
- Develop and execute the national US field medical strategy for SKY-0515 and future pipeline assets aligned with the Medical Affairs strategy scientific communications platform clinical development plan and lifecycle priorities.
- Design and build the US MSL organization including team size geographic deployment territory structure stakeholder prioritization hiring sequence and workload expectations.
- Recruit onboard coach and develop a high-performing MSL team establishing clear competencies objectives performance standards and career-development pathways.
- Personally establish relationships with nationally recognized experts investigators treatment-center leaders and professional organizations participating directly in Skyhawks highest-priority scientific engagements.
Scientific Exchange and External Engagement
- Ensure that MSLs conduct accurate balanced evidence-based and non-promotional scientific exchange with healthcare professionals and other appropriate stakeholders.
- Lead field communication of emerging clinical biomarker translational disease-state and real-world evidence related to SKY-0515 and the evolving Huntingtons disease treatment landscape.
- Develop a coordinated engagement strategy for Huntingtons disease centers movement-disorder specialists genetic counselors multidisciplinary care teams investigators and scientific organizations.
- Partner with Medical Affairs and Clinical colleagues to support advisory boards congress activities investigator interactions scientific meetings medical education and appropriate research collaborations.
Medical Insights and Evidence Needs
- Establish a structured process for capturing documenting analyzing prioritizing and communicating medical insights generated through field interactions.
- Translate insights into actionable recommendations for Medical Affairs strategy evidence generation clinical development publications scientific communications education and lifecycle planning.
- Identify evidence gaps clinical-practice barriers educational needs patient-journey challenges and stakeholder perceptions that could influence the development and appropriate use of SKY-0515.
Launch Readiness and Medical Execution
- Serve as the field medical lead on the cross-functional launch team ensuring that MSL hiring deployment training systems materials and stakeholder engagement are appropriately sequenced ahead of potential approval.
- Develop and execute the US field medical launch-readiness plan including disease-state education pre-launch scientific engagement stakeholder mapping insight generation and post-approval execution.
- Partner with Scientific Communications and Medical Information to provide the MSL team with current appropriately approved scientific resources response documents data summaries and frequently asked questions.
- Build a comprehensive scientific training and certification program addressing Huntingtons disease SKY-0515s mechanism of action clinical and biomarker data clinical trial methodology the competitive landscape and compliance requirements.
Team Development and Field Excellence
- Create a culture of scientific rigor patient focus accountability collaboration continuous learning and ethical decision-making across the US field medical organization.
- Conduct regular field coaching and performance reviews focused on scientific knowledge quality of engagement strategic execution insight generation and compliance.
- Establish consistent standards for field planning documentation CRM use reporting analytics and performance measurement.
- Manage the US field medical budget including headcount travel training congress participation technology and external resources.
Cross-Functional Leadership
- Partner closely with Clinical Development and Clinical Operations to support appropriate scientific engagement with investigators and research sites while maintaining clearly defined functional boundaries.
- Collaborate with Scientific Communications Publications Medical Information HEOR Real-World Evidence and Patient Advocacy to align field activities with broader Medical Affairs priorities.
- Work with Regulatory Drug Safety Legal and Compliance to ensure that field medical plans materials training and external engagements meet applicable requirements and company standards.
Compliance and Medical Governance
- Establish and maintain field medical policies procedures training documentation practices and governance processes consistent with applicable laws regulations industry codes and Skyhawk standards.
- Ensure that all MSL activities remain scientific balanced non-promotional appropriately documented and responsive to legitimate medical and scientific needs.
- Ensure timely reporting of adverse events product complaints and other reportable safety or quality information identified through field interactions.
- Maintain clear and compliant standards governing interactions with healthcare professionals investigators patients caregivers advocacy organizations and Commercial colleagues.
Requirements Education Experience and Skills
- 12 or more years of progressive experience in Medical Affairs Field Medical or a related biopharmaceutical function including substantial direct MSL experience and at least five years of people leadership.
- Demonstrated experience building expanding or transforming a national MSL organization including organizational design recruitment onboarding training coaching and performance management.
- Experience leading field medical activities through pre-launch and launch for a neurology orphan rare disease or similarly complex therapy.
- Experience in Huntingtons disease movement disorders neurology neurodegenerative disease or another high-touch central nervous system therapeutic area.
- Advanced scientific or clinical degree required such as an MD DO PharmD PhD or equivalent degree in a relevant discipline.
Additional Required Skills
- Strong scientific and clinical acumen with the ability to interpret and communicate clinical trial results biomarkers statistical analyses disease-progression data and emerging evidence.
- Demonstrated ability to establish credible peer-to-peer relationships with nationally recognized experts investigators and senior scientific stakeholders.
- Strong understanding of Medical Affairs compliance requirements scientific exchange medical insights CRM systems field analytics and appropriate MedicalCommercial collaboration.
- Ability to operate effectively in a small or emerging biopharmaceutical company and travel approximately 40% to 65%.
Desired
- Direct experience building and leading a US MSL organization through a rare disease drug launch.
- Experience supporting a first commercial launch first-in-class product novel mechanism of action or biomarker-driven development program.
- Established relationships within the US Huntingtons disease or movement-disorders community including Centers of Excellence multidisciplinary care teams research networks and patient organizations.
Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Head of US Medical Science Liaisons is $260000-$370000 annually. Skyhawk Therapeutics will assess the appropriate level and compensation for a qualified candidate based on job-related skills leadership experience professional background geographic location and relevant education or training.
About Skyhawk
Skyhawk is committed to discovering developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the worlds most intractable diseases including neurological conditions cancer and traditionally undruggable targets.
Required Experience:
Director
About Company
Skyhawk Therapeutics is a clinical-stage biotechnology company focused on the discovery and development of novel small molecule therapies designed to modulate critical RNA targets and revolutionize patient treatment for some of the world's most intractable diseases.