Senior Medical Director, Medical Affairs, North America (Metabolic/Neurology)

Ultragenyx Pharmaceuticals Brisbane , CA 94005

Posted 3 months ago

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best because we never lose sight of our mission to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities!

Position Summary

ultrainnovative Tackle rare and dynamic challenges

Ultragenyx is seeking an MD to provide medical leadership in the therapeutic areas of metabolic/neurology that include product portfolio and pipeline for North America.

In coordination with the Head of North America Medical Affairs (MA) and Global Medical Affairs, define and deliver the medical strategy for the North America MA metabolic and neurology team in line with regional medical affairs and business needs and provide leadership to ensure a clinically credible service is delivered to both internal and external customers.

Responsibilities, including but not limited to:

  • Reporting to the VP North America MA, the medical director/senior medical director of medical affairs metabolic and neurology contributes to the development of the North America medical affairs strategy, including medical launch strategy

  • Provides medical/clinical expertise and knowledge for the entirety of metabolic and neurology therapeutic area including new products or any other product assigned under his/her responsibility

  • Leads strategic assessment, planning, and execution of top strategic projects, related scientific communications and post-approval research initiatives

  • Participates in training and management activities within the respective regional medical affairs therapeutic area including Medical Science Liaisons, Patient Diagnosis Liaisons and from the Ultragenyx Commercial Liaisons when required

  • Provides medical/clinical expertise related to MA metabolic/neurology products and projects and their alignment and communication to internal (R&D, marketing, manufacturing, pharmacovigilance, quality assurance, regulatory affairs, and legal) and external (healthcare professionals, patients, advocacy groups, etc.) stakeholders

  • Provides responses to Pharmacovigilance, Regulatory Affairs and Quality requests and requirements

  • Represent North America medical affairs region at global franchise team initiatives or governance and partners closely with commercial teams

  • Is responsible for team oversight and execution of review and approval of advertising and promotional, as well as scientific and educational materials within the metabolic/neurology therapeutic area

  • Leads planning, development, and execution of top strategic North America MA projects including the North America MA strategy for metabolic and neurology therapeutic area in alignment with global medical and commercial strategies to optimize markets for Ultragenyx's future and current metabolic/neurology products, including indication expansion of licensed products with focus on North America. Conducts strategic assessment (gap analysis) of information needs within the North America region related to Ultragenyx metabolic/neurology therapeutic area and develops fulfillment strategies, e.g., publication/research planning, educational activities, attendance at key medical meetings and advisory boards, etc. in collaboration with other global MA and global commercial and development team members

  • Provides expert clinical and technical product knowledge in response to clinical/medical inquiries from external and internal stakeholders

  • Serves as a representative of North America MA in the advertising/promotional review committee, and provides editorial input related to product line with our metabolic/neurology therapeutic area

  • Develops/executes internal and external education/training programs with respect to medical/clinical issues within the product line

  • Possesses an advanced understanding and maintains current knowledge of Regulatory, Pharmacovigilance, Quality, and Clinical Operations requirements and contributes to respective requests from those functions

  • Possesses/maintains a deep and up-to-date knowledge of the published medical literature relating to the product line/therapeutic area and serves as a resource regarding clinical trends and their potential impact

  • Leads planning, development, and execution of top strategic North America MA projects including programs such as product launches Activities also may include development of training materials

  • Develops/executes scientific advisory boards related to topics of importance within North America MA metabolic and neurology franchise.

  • Serves as point of expert and coordination contact with countries MA teams from North America

  • Work in collaboration with country medical affairs the participation in global clinical trials and development of local medical education strategies including participation in local congresses

  • Works in collaboration with global medical affairs team members and other regional medical affairs functions to drive adoption and implementation of the global strategy in identified Ultragenyx regions, including new product launches

  • In preparation of a product launch, coordinate with local medical affairs team the development and execution of the medical launch excellence plan

  • Maintains knowledge base as to developments and trends in medical sciences related to metabolic and neurology diseases in particular

  • As requested present Ultragenyx product data to health care providers, payers, patients or government officials

  • Contributes to the training, leadership and continuing education for marketing, sales and medical affairs teams

  • Proactively builds and matures Ultragenyx regional KOL network, including playing a leading role in Ultragenyx's global/regional events, R&D Round tables, etc. that include thought leaders and clinical experts

Technical Requirements &

  • The ideal candidate will be an experienced medical affairs leader with knowledge of and a track record of delivery in metabolic and neurology diseases field as a clinician or with TA pharmaceutical industry experience

  • Preferable MD degree with clinical specialty in genetics with 6 years or more of pharmaceutical experience including portfolio management of rare diseases

  • Public speaking experience

  • In depth knowledge of pharmaceutical Code of Practice

  • Leadership & management experience including MSL operations from previous positions

  • Proven leadership of successful product launches and/or patient access programs

  • Proven relationship building skills with key opinion leaders

  • Leadership and strategic operational management success

  • Team-player - proactively sharing, coaching, leading and supporting colleagues

  • Developing valuable business relationships

  • Business acumen astute to business environment changes and potential of the service. Sensitivity to business leads and application of commercially sensitive information

  • Logical, problem solving approach to scope projects, assign priorities and manage a wide range of activities across team - organized and methodical style to progress multiple short and long-term goals

  • Innovator and self-starter - building experience, developing knowledge and processes to refine service provision for business gain. Considered risk-taking to further the service by identifying new added value services or areas of opportunities for Ultragenyx

  • Information management skill - Retrieval, interpretation and application of detailed diverse scientific information from appropriate sources. Excellent attention to detail and quality

  • Complementary analytical, scientific and business skill-sets to analyze/appraise the diverse clinical, biomedical and scientific details, delivering considered conclusions. Application of sound professional judgement. Practical application of information on Ultragenyx and competitor portfolio

  • Full practical knowledge and efficient application of business software and web systems

  • Clear, concise and comprehensive verbal and written communications

  • Ability to scan horizon for business development opportunities

  • Ability to manage a number of complex tasks in tandem using the art of delegation as appropriate

  • Work in a matrix organization, leveraging off other businesses and functions be an equal player in scarce resource allocation discussions

  • Support marketing colleagues to segment the market and lead medical input into planning process for the appointed franchise.

  • Communication be straightforward and act in time. Ability to present in an effective and compelling manner to various stakeholders

  • In depth knowledge of North America healthcare system

  • Ability to manage external stakeholders across a variety of scenarios from KOLs to government bodies, patient and industry associations

  • Can negotiate at a high level in a complex environment, with many agendas and in ambiguous situations

  • Project management and business reorganization skills

  • Ability to travel (for business meetings at least 50% of time)

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.


Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to:

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Director Of Regulatory Affairs & Quality Assurance


Posted 4 days ago

VIEW JOBS 8/21/2019 12:00:00 AM 2019-11-19T00:00 Position Summary: The individual is responsible for activities which lead to, and maintain regulatory approval to market devices. Additionally, the individual is responsible for assessment of device changes for regulatory implications and develop strategies for submissions and maintenance of documentation within the framework of regulatory requirements in an efficient manner. Duties and Responsibilities: * Develop strategies for regulatory approval of medical devices. * Responsible for preparation and submission of 510(k)s, IDEs, and Technical Files (CE Mark) to support the multiple product lines. * Identifies plans and develops strategies to meet the regulatory requirements that permit the successful registration of products worldwide. * Identifies, develops, and implements worldwide regulatory strategy initiatives based upon business needs. * Identifies, develops, and implements innovative process initiatives that promote efficiency of worldwide registrations. * Organizes project teams, initiates project schedule documentation and provides project leadership on a worldwide basis in order to achieve desired outcomes within timeframes defined. * Will participate in new business development activities as needed. This position will require interaction with the U.S. FDA and other regulatory authorities around the world and will participate in audits and other applicable activities. * Coordinate submission activities for a variety of device regulatory approvals including: US pre-market approvals, international design dossiers and/or technical files, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings. * Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes. * Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization. * Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams. * Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits. * Participate in training and mentoring of staff. * Coordinate IFU development activities. * Participate in department systems development initiatives. * Prepare deliverables for Management Reviews. * Develop innovative means to comply with regulatory requirements in an efficient manner. * Maintain compliance with FDA, GMP/QSR, Manufacturing process/Work Instructions and ISO 13485. * Other duties as assigned. Position Requirements: * Bachelor's Degree in scientific field is required or equivalent experience. A Master's degree is preferred * Eight-Plus years of related regulatory experience in the medical device industry, particularly 510(K) and Health Canada and other international locations * High level of attention to details and organization skills. * Effective verbal and written communication skills. * Demonstrated aptitude for preparing and submitting 510(k)'s in addition to preparation of EU Design Dossiers and experience with the GHTF. * Prior interaction with the FDA and other worldwide agencies is required. * Experience working with cross-functional teams is required in addition to previous aptitude thriving within a complex regulatory environment. * Ability to provide innovative solutions within the boundaries of regulation, have the ability to organize data and identify issues or gaps, and have the ability to effectively communicate in oral and written forms. * Thorough knowledge and understanding of FDA's QSRs, ISO 13485:2003 and MDD 93/42/EEC and other national/international standards. * Hands on ability to lead a group of individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team. * Ability to link functional responsibilities to overall business goals, and to manage and prioritize multiple projects simultaneously. Previous experience mentoring and training staff is Preferred. * Proficient in use of MSWord, MSExcel, PowerPoint is required. * Good writing skills and formatting skills. * Ability to work well under pressure and handle multiple projects and meet deadlines. * Ability to read and understand regulations, standards and procedures. * Good leadership, analytical and interpersonal skills. Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer. Cutera Brisbane CA

Senior Medical Director, Medical Affairs, North America (Metabolic/Neurology)

Ultragenyx Pharmaceuticals