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Alexion Pharmaceuticals Commercial Diagnostics Strategy and Planning Head, VISion in New Haven, United States

This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA or be remote/virtual, based anywhere in the United states and may require up to 50% travel.

Commercial Diagnostics Strategy & Planning Head

Position Summary

At Alexion, our mission is to transform the lives of people affected by rare diseases and devastating conditions by continuously innovating and creating meaningful value in all that we do. We know that rare disease patients frequently face a challenging diagnostic odyssey and want to make a difference in shortening such journeys, improving identification patients who would benefit from treatment, and assuring the effectiveness of our therapies. The Commercial Diagnostics Strategy & Planning Head will lead Commercial input into diagnostics strategy and planning. This highly visible role will collaborate closely with VISion, cross-functional, and regional counterparts to improve the path to diagnosis for rare disease patients and advance the impact of Alexion’s solutions. We believe that this is a transformational position within our organization that will shape the way we approach precision medicine as a company through strong collaboration, internal capability building, and strategic vision across the organization.

The position is best suited to an individual who has deep commercial expertise (product design and development, marketing, launch, sales, lifecycle management) and demonstrated experience in diagnostics development (in vitro diagnostic and lab developed test design and development, partnership selection and management, regulatory pathways, etc.). The ideal individual for this role is also recognized as a persuasive and influential leader with the ability to formulate strategy, facilitate approval, guide implementation, and evaluate success.

The position reports to the Head, Commercial Excellence of the Boston-based VISion Team, working closely with the broader VISion leadership team and the Diagnostic Center of Excellence (DX COE) within Research and Development.

Job Duties, Scope & Responsibilities

  • Responsibilities

Implementation of the Biomarker and Diagnostic Commercial Strategy:

  • Implement the commercial strategy component, focusing on people, processes, and governance of Alexion’s newly formulated global diagnostics strategy, intended to span all disease areas and demonstrate Alexion’s commitment to patient-centricity.

  • Integrate the strategy into the Alexion Product to Patient (AP2P) model and stage-gate review process, as well as the PROPEL launch excellence model for pipeline and near-to-market therapies.

  • Partner with the Diagnostics Center of Excellence to deliver training on the diagnostics strategy to cross-functional partners who will be involved in diagnostics projects.

Development of Commercial Diagnostics Strategies:

  • Develop strong partnerships with VISion counterparts in marketing strategy, value and access, new product strategy, competitive intelligence, launch planning, and operations and cross-functional counterparts – diagnostics strategy and planning in R&D, Clinical Development, Medical Affairs, Regulatory, Data Sciences and Genomics

  • Identify and evaluate unmet needs in the diagnostic odyssey for each disease and/or mechanism of action in the Alexion portfolio through:

  • Close partnership with TA Leaders and Global Development Teams.

  • Interpretation of advanced analyses of health care data performed by internal or external partners.

  • Quantify and qualify the unmet needs and the associated business case to help Alexion prioritize diagnostics investments toward the areas of greatest potential impact.

  • Serve as a commercial subject matter expert on diagnostic technologies and strategies with specific focus on pipeline therapies.

  • Collaborate with leaders responsible for market-facing diagnostics engagement (e.g. US Commercial Diagnostics Strategy Head) to build a go-to-market framework for diagnostics that support emerging therapies that align with Alexion’s internal capabilities.

  • Explore novel and innovative diagnostic strategies (e.g. digital biomarkers and diagnostics) and collaborate cross-functionally to develop, deliver, and integrate into organizational ways of working.

Implementation and Lifecycle Management of Commercial Diagnostics Strategies:

  • Work closely with subject matter experts across Alexion’s Research, Development and Commercial organizations to create and implement diagnostic solutions

  • Represent VISion and broader Commercial interests on the Diagnostics Center of Excellence and partner with the COE to represent Diagnostics on Global Development Teams and Therapeutic Area teams, as needed.

  • Oversee and execute day-to-day work of the Global Commercial input into diagnostics programs to deliver diagnostic objectives in support of Alexion’s program and portfolio objectives; in some cases, provide program management for those efforts, typically working closely with a program manager.

  • Develop and maintain expertise in multiple technical areas and technologies likely to be explored in diagnostic development.

  • Maintain knowledge about the landscape of potential diagnostics partners and vigilance as it relates to competitor activity in the Dx space through collaboration with Competitive Intelligence.

  • Skills & Experience

  • Experience in medium and large biotech, biopharma, and/or diagnostics companies.

  • Demonstrated strategic and critical thinking abilities and business acumen.

  • Strong ability to listen to and interpret data, think about the story it is trying to tell, and effectively communicate the findings to key stakeholders. Inquisitiveness to anticipate and answer the follow up questions.

  • Strong project and team leadership skills, with the ability to dig in and manage multiple projects simultaneously, lead cross-functional teams, and manage budgets.

  • Excellent oral and written communication skills.

  • Expertise using Microsoft Office tools including Word, Excel, and PowerPoint.

  • Reporting

  • Ensure the voice of the customer (patient, caregiver, healthcare professional, payer, policymaker, advocacy organizations), informs critical business decisions.

  • Provide regular updates to internal teams and key stakeholders on progress and key next steps.

  • Provide compelling presentations and updates to senior/executive management on critical issues and opportunities.

  • Conduct evaluations post-project to assess performance and identify process improvements.

  • Managing Internal & External Resources

  • Manage budget, as assigned.

  • Initiate RFPs with vendors and manage vendor selection process.

  • Manage vendor interactions to ensure projects meet critical timelines and deliver at the highest levels of quality and excellence.

  • Partnering & Communication

  • Develop strong partnerships with VISion counterparts in marketing strategy, value and access, new product strategy, competitive intelligence, launch planning, and operations and cross-functional counterparts – diagnostics strategy and planning in R&D, biomarkers, clinical development, regulatory, data sciences and genomics, medical affairs, et al.

  • Build and maintain a network of internal and external subject matter experts.

  • Collaborate to convene the best minds from within and outside Alexion to solve challenging problems.

  • Ensure regional diagnostics and business unit (sales, marketing, account management) counterparts are engaged at key stages of projects to:

  • Address critical business questions.

  • Secure full team buy-in on projects and deliverables.

  • Identify best practices and share with global, cross-functional teams.

  • Incorporate future business needs in scope and design of projects.

  • Go beyond a project-based mindset and be a strategic partner. Offer strategic insights, communicate these clearly, and ensure that these drive business decisions.

  • Remain flexible as work responsibilities change based on business needs.

  • Compliance and Legal Requirements

  • Ensure work products meet compliance and legal requirements.

  • Embrace and exemplify Alexion values & integrity.

Essential Qualifications

  • Bachelor’s degree in life sciences, business, and/or marketing

  • 15+ years of experience leading the development, launch, and lifecycle management of diagnostics within biotech and/or diagnostic companies.

  • Exceptional demonstrated partnership, collaboration and communication skills and experience working with diverse teams across the drug discovery, development, and launch spectrum.

  • Excellent understanding of biomarkers and diagnostics, including regulatory pathways

  • Demonstrated capability to deeply understand disease and scientific areas. Rare disease experience is not required but is a plus.

  • Experience with assay and diagnostics development including IVD and companion diagnostics.

  • Strong collaboration skills and experience in effectively managing CROs.

  • Strong knowledge and experience of the drug discovery and development process.

  • Strategic agility and ability to adapt to the evolving competitive landscape.

  • Leadership experience, with a delivery mindset. Ability to do the work themselves when necessary, self-starter.

  • Fluency in English, both written and oral, are mandatory requirements

  • Ability to travel >20% of time

Preferred Qualifications

  • Master’s or doctoral degree – life sciences, business administration, management, marketing, strategy

  • Academic or practical (bench) experience developing diagnostics

  • Experience in specialty/orphan drugs

  • Experience in hematology, neurology, nephrology, and/or metabolic diseases

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Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

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