Head – Global Medical Affairs

Oak Hill Bio Ltd; United States; Ibrido; USD 350.000 - 700.000; Tempo pieno

Descrizione del lavoro

Oak Hill Bio Ltd in the United States seeks an experienced leader to build and scale its Global Medical Affairs organization. You will shape the scientific platforms, evidence-generation engines, patient advocacy programs, and field capabilities to support a commercial launch and portfolio expansion.

You will lead global medical strategy through late-stage development, regulatory submissions, and lifecycle management, engaging KOLs, investigators, and patient groups in a lean, fast-paced biotech

Competenze

• 15+ years of progressive biopharmaceutical industry experience in Medical Affairs and executive leadership.
• Proven success scaling global Medical Affairs capabilities and teams.
• Experience launching late-stage assets (Phase 2/3) through approval to commercialization.
• Background in rare diseases or pediatric indications preferred; neurology/neurodevelopmental disorders a plus.

Mansioni

• Establish global Medical Affairs architecture, operating model, SOPs, governance, and budget across programs centered on rugonersen.
• Translate complex clinical data into a rigorous global medical platform.
• Execute Integrated Medical Plans aligning engagement, education, and launch readiness with corporate goals.
• Serve as the voice of Medical Affairs across leadership, steering committees, and cross-functional teams.
• Lead a global Field Medical/MSL organization with clear territory alignment, training, and metrics.

Conoscenze

Executive leadership

Medical affairs strategy

Global team building

KOL engagement

Evidence generation planning

Formazione

Advanced degree (MD/PhD/PharmD)

Descrizione del lavoro

Location:United States (East Coast preferred); Global Remit

Position Summary

Oak Hill Bio is a clinical-stage biotechnology company focused on acquiring and developing outstanding rare disease drugs that have been deprioritized by big pharma.

The person in this high-impact executive role will build, scale, and lead Oak Hill Bio’s Global Medical Affairs organization from the ground up. Anchored by our lead program, rugonersen (OHB-724)—currently in its global pivotal Phase 3 study (BEACON) for Angelman syndrome—you will serve as the architect of our global Medical Affairs infrastructure. Partnering with the CMO and executive leadership, you will establish the scientific platforms, evidence-generation engines, patient advocacy programs, and field capabilities required to prepare Oak Hill Bio for commercial launch and portfolio expansion.

The person in this role will define and execute our global medical strategy through late-stage clinical development, regulatory submission, global launch readiness, and lifecycle management. The person in this role will build an agile team, while directly engaging global key opinion leaders (KOLs), investigators, and patient advocacy organizations. This role requires an entrepreneurial leader who thrives in a lean, fast-paced biotech environment and seamlessly balances strategy with hands-on execution. This person is an influential leader, responsible for building and leading in a high-performing culture.

Responsibilities

Global Medical Strategy & Leadership

• Establish the global Medical Affairs architecture, operating model, SOPs, governance, and budget across rare and pediatric programs, centered on rugonersen.
• Translate complex clinical data (including the Phase 3 BEACON and Phase 1 TANGELO studies) into a scientifically rigorous, compelling global medical platform.
• Execute Integrated Medical Plans (IMPs) aligning scientific engagement, publication strategy, medical education, field operations, and launch readiness with corporate goals.
• Serve as the voice of Medical Affairs across executive leadership, steering committees, and cross-functional teams (Clinical Development, Commercial, Regulatory, Legal/Compliance).
• Track the evolving rare disease and neurodevelopmental landscape to inform strategic direction.

Evidence Generation & Lifecycle Management

• Lead an integrated evidence-generation strategy to address scientific gaps, support regulatory/access goals, and deepen clinical insights.
• Oversee post-authorization studies, registry collaborations, natural history frameworks, real-world evidence (RWE) initiatives, and investigator-sponsored research (ISR).
• Direct compliant Expanded Access Programs (EAP) and Compassionate Use frameworks.

External Scientific Engagement & Field Operations

• Recruit, scale, and lead a global Field Medical / MSL organization, establishing territory alignment, training, and performance metrics.
• Cultivate direct partnerships with international scientific experts, clinical investigators, and key academic centers.
• Lead Oak Hill Bio’s patient advocacy strategy to ensure caregiver and patient perspectives shape corporate initiatives.
• Support clinical trial execution with Clinical Operations while maintaining strict compliance boundaries (e.g., blinded, sham-controlled protocols).

Scientific Communications & Medical Information

• Direct the global publication and congress plan, overseeing high-impact peer-reviewed manuscripts, abstracts, and presentations.
• Build compliant Medical Information workflows, scientific content repositories, and inquiry escalation pathways.

Building the OHB Team

• Keeps patients at the center of every decision
• Holds themselves and the company accountable for delivering results the right way
• Inspires and models strong collaboration to deliver company goals
• Champions growth, develops people at every level, and seeks feedback on their own leadership

Qualifications & Experience

• Advanced scientific or clinical degree required (MD, PharmD, or PhD).
• 15+ years of progressive biopharmaceutical industry experience, featuring executive leadership in Medical Affairs and a track record of scaling global capabilities.
• Proven success leading global Medical Affairs launch readiness for late-stage (Phase 2/3) assets through approval and commercialization.
• Strong background in rare diseases or pediatric indications strongly preferred. Experience in neurology, neurodevelopmental disorders, or genetically targeted modalities (e.g., ASOs, intrathecal therapies) is a plus.
• Demonstrated success establishing Field Medical/MSL teams, patient advocacy functions, and expanded access programs.
• Deep understanding of clinical trial design (including blinded/controlled methodologies), global regulatory/compliance frameworks, and cross-functional boundaries.
• Proven ability to operate effectively in a lean, matrixed, entrepreneurial environment, with the scientific gravitas to engage as a peer with top global KOLs.

• Builds a high-performing culture within their function and develops their managers into strong leaders and coaches.

• Regularly coaches high-potential talent and creates an optimal environment for sustainable high performance, modeling the respect expected across the organization.

The base salary range provided is for US-based employees only, and is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. Oak Hill Bio will use local market rates for roles outside the US.Actual base salary pay will be based on several factors, including geography. skills, competencies, experience, and other job-related factors permitted by law.

The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria necessary to successfully perform this position.