• Director, Translational Medicine Lead

    Horizon Therapeutics Rockville, MD 20851

    Job #2280832546

  • Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

    Responsibilities:

    • Lead and oversee Translational Medicine leads on multiple late stage (Ph3/4/LCM) clinical programs to ensure a coordinated approach and timely deliverable of biomarker data.

    • Represent TM in senior level meetings to communicate a coordinated biomarker strategy and set expectations around deliverables and timelines.

    • Work with Snr Director of Translational Medicine to map resources and timelines across the portfolio.

    • Work with Snr Director Translational Medicine to grow and expand team and educate key stakeholders on the value of biomarkers to clinical drug development.

    • As individual Translational Medicine lead develop and execute translational strategies to achieve project-specific goals and objectives for investigational therapeutics in clinical development.

    • Represent the Translational Medicine function in cross-functional drug development teams.

    • Work within a matrixed, cross functional team to provide end to end oversight of biomarker sample collection, testing and analysis.

    • Initiate and oversee contracting and sample analysis with CROs to execute biomarker testing plans.

    • Track budgets and deliverables.

    • Establish fit for purpose biomarker assays internally or with third party vendors.

    • Evaluate new technologies and assay platforms for clinical biomarker use.

    • Guide data analyses in collaboration with Biometrics and Quantitative Biology colleagues to deliver informative analyses to support internal decision making, regulatory interactions and publications/abstracts.

    • Author biomarker sections of clinical and regulatory documents (protocols, CSR, IB, USPI, sBLA, PIP etc).

    • Generate, present and defend biomarker data for health authority filings.

    • Work with Clinical, Commercial and Medical Affairs to identify evidence gaps and build translational plans to address these.

    • Establish collaborations with KOLs and academics to generate samples to investigate biomarker sampling, patient subgroups and endotypes.

    • Collaborate with Research and Commercial to provide scientific reason to believe for new disease indications under consideration.

    • Work with the publication planning teams to ensure coordinated approach to scientific communication for clinical stage assets.

    • Represent Translational Medicine at internal and external meetings to show case value of biomarker data and learnings from HZN biomarker studies.

    Qualifications and Skills Required:

    • PhD in immunology or relevant scientific discipline; minimum PhD in immunology or relevant scientific discipline; minimum PhD +10-13 year (or BSc + 15-18 year, MSc +13-16 year)

    • Proven leadership ability and ability to motivate and unify team

    • Prior experience delivering biomarker data from clinical trials

    • Prior experience with regulatory filings is preferred but not required

    • Experience with a variety of drug modalities (small molecule, biologic, etc.)

    • A calling to develop new therapies for patients with inflammatory diseases.

    • A broad understanding of cellular and molecular pharmacology concepts within the autoimmunity and/or immunology field is essential.

    • Ability to work in a fast-paced environment with rapidly changing and competing priorities and ambiguity.

    • Excellent planning and strategic thinking

    • Familiarity with a variety of biomarker assay platforms

    • Prior experience analyzing big data

    • Proficient in Microsoft Office.

    • Professional, proactive demeanor.

    • Strong interpersonal skills.

    • Excellent written and verbal communication skills.

    Horizon Core Values & Competencies:

    Growth

    • Manages Ambiguity

    • Strategic Mindset

    • Demonstrates Self-awareness

    • Cultivates Innovation

    • Develops Talent

    Accountability

    • Drives Results

    • Ensures Accountability

    • Decision Quality

    Transparency

    • Courage

    • Collaboration

    • Instills Trust

    Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.

    Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.