US Medical Affairs Lead- Hematology

Summary

Lead the development of US Hematology medical/scientific strategy and execution of core medical affairs activities such as healthcare/provider interactions; educational initiatives (medical education, data, guidelines, and value proposition) and patient identification in support of hemophilia clinical program. This role will work closely with sales, marketing, and commercial teams to provide strategic medical input into core brand strategies, support medical/marketing activities, and market access. The role will share scientific and technical expertise for gene therapy programs, deliver scientific presentations, and develop and maintains credible relationships with key opinion leaders.

This role will Interact with and drive scientific and medical initiatives with internal stakeholders (Regulatory and Clinical Development/Operations). He/She will also develop and foster strong US KOL relationships and be the primary point of contact of US research-based opportunities, including investigator-initiated research (IIR). Management responsibilities may become a part of the role.

This role will actively engage with US Brand Teams to help inform brand strategy, generate and deliver medical education for internal and external customers, and oversee the accuracy of medical/scientific content used in external company materials.

He/she will representUSMedical Affairs with broad responsibilities, influence and impact across the business, including developing strong, efficient and effective operations globally; supporting business development and licensing initiatives; participating in due diligence activities. This role will also contribute to and help manage the medical affairs operational budget, monitor expenses and be responsible for optimal medical resource allocation.

RESPONSIBILITIES:

25%

Leverage subject matter expertise to assess educational needs; apply therapeutic/disease area expertise and clear business understanding to addresscurrent and future needs of clinical practice. Develop training materials and new data analyses in collaboration with US KOLs.

25%

Develop and cultivate long-term strategic partnerships with US clinical experts, societies, collaborative groups, advocacy groups and other external stakeholders at the regional and national levels. Liaise with US MSL leads to ensure seamless implementation of USMA strategy. Provide US medical perspectives to Regional Leads and US commercial colleagues as needed.

15%

Medical Leadership for US medical information, copy approval and publications:

Provide high quality, balanced and timely clinical, medical and scientific information upon the request of healthcare professionals, consumers and other functional areas Provide medical review and approval of all promotional materials in compliance with US regulations, Spark’s SOPs, and Guidance Manuals Contribute to effective publication planning procedures to ensure consistent and meaningful scientific communication

20%

Lead US Medical activities for US advisory boards, US symposia, and US medical meetings, ensuring compliance and adherence to company policy

10%

Consult with key internal units, including R&D, Clinical R&D and Commercial to develop and drive key strategic Medical/Scientific Affairs elements for cross-functional projects such as clinical development studies for regulatory approval in the US, market access clinical support, and patient identification activities

5%

Other duties and projects as assigned by manager

EDUCATIONAL AND EXPERIENCE REQUIREMENTS:

MD, DO, MB BS degree is required; Clinical hemophilia experience or industry Medical Affairs experience in hemophilia required; Generally, 5years of experience in within Medical Affairs in the pharmaceutical / biotech industry, with demonstrated ability to build positive internal and external relationships and lead strategic initiatives. Patient care experience in the USA can be substituted for medical affairs experience if it involved managerial experience as a Hemophilia Treatment Center Director and experience in collaborations with the pharmaceutical/ biotech industry.

COMPETENCIES:

Successful track record of managing complex projects and teams Working knowledge of US Regulatory environment and clinical trials Excellent oral communications skills (particularly influencing and explaining/teaching) Excellent diplomatic skills with the ability to manage differing opinions and perspectives Familiarity with and excellent relationships with key opinion leaders The successful individual will be empowering and a self-starter capable of working independently. They will need to have excellent leadership, communication, and influencing skills. The individual in this position is expected to foster teamwork and collaboration.

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Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Nearest Major Market: Portland Oregon

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.