Medical Director, Oncology Clinical Development

If you are a Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

Jazz Pharmaceuticals is seeking a clinical development associate medical director or medical director to join a team in Oncology drug development. You will be responsible for contributing to the formulation and executing the Global Development Plan (GDP) for the assigned molecule and indications. The focus of this role will be a solid tumor Oncology asset with significant potential across multiple indications.

Responsibilities may include clinical leadership of projects supporting the development program strategy, supporting data management and data cleaning activities of oncology studies, supporting the medical monitor in routine trial activities and oversight for oncology studies, supporting regulatory submissions, and/or representing clinical development in multidisciplinary teams within Research and Development (R&D).

Essential Functions/Responsibilities

• Participate in the cross-functional team meetings and address study or other program-specific questions.
• Support execution and implementation of the Global Development Plan by providing strategic clinical science support for assigned studies and programs.
• Assist in reviewing and authoring study concept documents and clinical study protocols.
• Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision-making.
• Contribute to or prepare clinical sections of relevant regulatory filings and meeting packages (INDs, meeting requests, NDAs, etc.)
• Help to identify clinical investigators and coordinate activities for the conduct of clinical trials and advisory board meetings.
• Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials and ensure high standards of study conduct are met.
• Prepare clinical data and clinical program presentations.
• Review clinical study data; identify and evaluate study data trends, outliers, and protocol deviations; work with data management to issue and resolve queries to ensure data quality.
• Contribute to clinical study reports, including reviewing and interpreting safety and efficacy data.
• Write protocol summaries, process documents, investigator brochures, etc., in collaboration with cross-functional groups.
• Provide input on clinical presentation slides for internal/external meetings and communications (e.g., investigator meetings, pre-study site selection visits, site training, study newsletters, communication to sites, etc.)
• Participate and develop communication strategies for existing and concluded studies through KOL interactions, advisory boards, scientific and industry conferences and meetings, and publications.

Required Knowledge, Skills, and Abilities

• Three plus years of pharmaceutical development experience in oncology (ideally in relation to solid tumor assets).
• Demonstrated scientific and therapeutic expertise in the development of ADC, HER2 specific or similar solid tumor Oncology treatments.
• Experience in leading the design, conduct, analysis and reporting of clinical studies, including interactions with regulatory agencies.
• Excellent written and verbal communication skills and proven ability to work in an international collaborative environment.
• Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships.
• Excellent organizational and time management skills, ability to lead and manage multiple complex projects.
• Demonstration of Jazz values in previous employment
• Ability to work proactively and effectively, with creative problem solving skills.
• Willing to travel (variable, 10%-20%)

Required/Preferred Education and Licenses

• Medical degree, MD or equivalent (DO, PharmD, PhD), with experience in Oncology.
• D or equivalent (DO, PharmD, PhD), with experience in Oncology.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US-BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.

For this role, the full and complete base pay range is $240,000-$360,000. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: