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In collaboration with executive Americas (US, Canada, and LATAM) leadership and cross-functional global matrix leadership teams, this person will define medical affairs' strategy and goals. They will oversee operations, budget and tactical execution, while maintaining Medical Affairs excellence, policies and procedures. He/she will advance collaborations with key opinion leaders and establish and execute strategic plans for scientific engagement with health care practitioners, research groups, and centers of excellence.

The VP, Medical Affairs - Americas leads strategy and tactical execution across assets and manages a team of Medical Directors with direct reports (field medical liaisons and clinical theranostic specialists). They are accountable for clinical trial recruitment strategies to support on time development Ph1-Ph4 registrational trials, expanded access programs, and lifecycle management. They are an expert across the Telix portfolio and are considered a SME.

Finally, they will work closely with internal department stakeholders including clinical development, clinical operations, marketing, market access, global medical communications, pharmacovigilance, and the commercial department to provide Medical Affairs input to product development and launch strategies across lead assets for Americas regions (US, Canada, LATAM).

Key Accountabilities

• Lead Medical Affairs strategy and execution across Americas (US, Canada, LATAM) aligned and to support commercial/marketing departments and corporate objectives within clinical pipeline and commercial launches.
  • Responsible to ensure Illuccix, Zircaix, and Pixclara launches through clinical mindshare, regional publication data gap needs, robust IIT strategy and execution end to end, reader training development and implementation success, medical information request follow up and support regional standard response letters within the respective region.
  • Stay abreast across current guidelines, key publications to drive clinical efficacy positioning, competitive intelligence training across Medical Affairs team for consistent communication.
  • Strong communication plan and oversight around initiatives to internal and external stakeholders.
  • Responsible for the clinical strategy and support Marketing materials development, sales training, and Medical Review in Veeva for internal and external facing stakeholders within the respective region.
• Lead scientific engagement strategy with key opinion leaders (KOLs), healthcare providers, professional societies, and delivery of medical education and scientific communication
  • Develop metrics for KOL engagement by guidelines, institutions, subspecialty across various regions, ability to shift and make decisions and inform cross functional strategies that are data driven.
  • Strong publication and congress strategy and execution. Podium strategy includes properly preparing speakers prior to podium.
  • Support the expansion of theranostic clinical practice through evidence generation, data gap identification and dissemination, and collaborative partnerships, opportunities, and relevant field intelligence to inform medical/clinical strategy and cross functional stakeholders.
  • Identify data gaps for payors, HCP unmet need, guidelines, societies, lead publication strategy and timelines in collaboration with med comms
• Accelerate recruitment efforts and enhance subject retention at targeted clinical trial sites and support lifecycle management.
  • Responsible for clinical trial recruitment strategies to accelerate on time trial milestones. Work closely with clinops to identify gaps with sites and patient accrual. Develop metrics to inform and stay on target.
  • Drive medical/scientific meetings, site engagement meetings. Lead advisory boards in colloboration with development needs. Support Investigator meetings with high collaboration and coordination with clinops. Capture, integrate, inform cross-functional strategies for lifecycle management
  • Lead Investigator-Initiated Research strategy and matrix alignment needs across development, regulatory, clinical, and marketing.
  • Expert knowledge of Telix pivotal trial designs, IB, and ability to review and inform as a Medical lead on protocol design from MA perspective of where the field is moving and KOL feedback, adding value to clinical relevance.
• Maintain a high-performance team with tactical execution, clear strategy, and operational excellence.
  • Metric for performance coaching and metrics around team performance, team meetings
  • Accountable for team SME training and expectations across portfolio, literature, key trials, and competitive intelligence. Including abreast of Telix investor presentations and competitors. Develop SME plan, expectations and metrics for team SME
  • Maintain a high level of team knowledge of and appropriately implement current local pharmaceutical regulation and ensure implementation of Telix policies and procedures. Ensure all MSL activities, including external interactions, are conducted in accordance with Telix objectives, compliance policies and procedures as well as with legal and ethical standards.

Education and Experience

• Advanced scientific, healthcare, or medical degree (ex: PharmD, PhD, MD) required.
• 10+ years' experience in biotech, pharma or related areas required.
• 5+ years in a leadership role required.
• Expertise in Prostate, Renal, and Neuro-Oncology radiopharmaceuticals strongly preferred.
• Demonstrated success in fostering close partnerships across functions and diplomacy.
• Ability to travel of 50-75% regionally. International travel may be requested.
• Comprehensive knowledge of in-depth medical affairs activities including key pivotal trials and medical landscape of prostate, renal, and neuro-oncology.
• Experience in a pharmaceutical environment with strong knowledge of relevant compliance and regulatory environment.
• Proven track record in the areas of medical strategy, product launches, lifecycle strategy, data generation gaps, and thought leader engagement.
• Experience with package insert development, trial designs of EAP and Registries.
• Ability to lead, inspire and influence a US MA team, functioning in a matrix structure, through vision and strategy setting.
• Self-reflective and aware of their own limitations, a great listener, open to feedback and self-improvement.
• Demonstrated business acumen; excellent people management and leadership skills, able to manage complex technical organizations.
• A proven ability to execute and get results through leading others whilst leading by example.
• Demonstrated ability to build successful relationships and develop partnerships with key business partners and investigators.
• Strategic thinking and innovative mindset.
• Strong interpersonal and communication skills, forging relationships with various internal and external stakeholders.
• Strong multi-tasking, highly detailed oriented and organizational skills with great consistency is a must.
• Excellent written and verbal communication, organization, and cross-functional collaboration skills.