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Head of Medical Affairs

Date: Dec 6, 2018

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

Summary

Reporting to the Chief Medical Officer, the Head of Medical Affairs is accountable for ensuring strategic and operational excellence of the Medical Affairs function and its members on a global basis. This individual will be responsible for a team of Medical Affairs professionals spanning both in-house and field-based teams who are responsible for medical strategy, medical information, publications/communications, and medical expert engagement for Spark’s product pipeline.

While keeping the urgent needs of our patients in the forefront, the Head of Medical Affairs will partner closely with colleagues in clinical R&D, pharmacovigilance, regulatory, commercial, corporate strategy, communications, legal and compliance and others to develop and execute the short and long-term strategy for marketed products as well as products in development.

Responsibilities

15% 

  • Oversee the development of medical strategies for Spark products that can be used to guide development of robust medical plans that meet the needs of local markets.

15%

  • Ensure integration and optimization of the product communication strategy at the portfolio level. Execute the communications plan supporting the scientific needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, supporting CME, writing of abstracts/publications, as appropriate and required).  Responsible for all medical communication aspects of scientific and clinical studies, regulatory submissions, and post-approval market support.

10% 

  • Partner with Commercial to provide strategic medical insights to shape the portfolio strategy; provides strategic medical and scientific input and day-to-day advice to the commercial team and other relevant functions. Provide medical support for access strategy, including presentations.  Provide medical review of product-related materials, as required.  

10% 

  • Establish and maintain strong working relationships with key external stakeholders (medical experts, medical societies and managed care organizations, patient advocacy groups, clinical/medical stakeholders)

10% 

  • Oversee the planning and implementation of external exchange including conferences, industry groups, Ad Boards, etc; develop or adapt internal strategies to reflect the output of external scientific boards.

10% 

  • Provide oversight for medical information activities, ensuring that responses are fully reflective of current data knowledge

5% 

  • Provide strategic input and medical due diligence to M&A and licensing activities where warranted.

10% 

  • Partner with the Compliance and Legal Departments to ensure that all Medical Affairs activities are conducted in a manner that is compliant with Spark policies, procedures, and local regulatory/legal requirements. 

15% 

  • Provides leadership to team members including managing performance, developing people, hiring and integrating new team members and fostering Spark’s culture, mission, vision and values. 
  • Establishes processes to ensure that team members are training on gene therapy, therapy areas of focus, products, regulations and other content required for success.

Qualifications

• Advanced understanding of clinical medicine/clinical pharmacology, and associated disciplines (eg, biostatistics) drug development principles

• Strong written communication and presentation skills

• Capable of effectively engaging with internal and external stakeholders and building relationships

Setting Strategy 

• Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty

• Intellectual curiosity and dedication to science, innovation, and complex problem-solving

• Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy

Executing for Results

• Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process

• Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice

• Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization

Leading Teams

• Embraces and embodies the Spark values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient;”

• Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and step back to allow others to take action

• Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable

Building Relationships and Using Influence

• Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual

• Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities

• Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Spark

 

Requirements

• MD required, significant experience in a therapeutic area of interest to Spark is valuable (e.g., immunology, CNS/neurology, ophthalmology, hematology, hepatology, inherited storage diseases, etc). 

• Generally has 10 - 15 years of relevant academic/clinical and significant global industry experience. Demonstrable executive leadership experience in Medical Affairs in a pharmaceutical/biotech organization, having led a regional/global medical affairs team. 

• Track record of having played a central role (from a medical perspective) in product launches. 

• Solid understanding of the global regulations that govern Medical Affairs activities as well as detailed knowledge of common local, medical practices and treatment habits

• Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants. 


Nearest Major Market: Philadelphia

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