Director of Clinical Development, Oncology
Job Details
- Req ID:
- R009522
- Location:
- Palo Alto, CA -- [Remote/Home-Based]
- Category:
- Research & Development
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Brief Description:
Jazz Pharmaceuticals is seeking a clinical development physician to join a team in hematology oncology drug development. You will be responsible for development of clinical studies, the oversight and interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including R&D, commercial, regulatory, and business development, and with external stakeholders, including regulatory agencies and thought leaders.
Essential Functions
Devise strategy for, develop, and implement clinical studies for investigational medicines and new indications for approved medicines
Work closely with other functional areas within R&D (including clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs, and senior management
Provide clinical/scientific input during the development, execution, and completion of clinical trials
Interpret clinical trial data and prepare reports, regulatory submissions, and publications based on the results
Monitor clinical trials for safety
Work in conjunction with Product Safety to insure timely reporting of safety signals to regulatory authorities
Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
Serve as lead medical representative with regulatory agencies
Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
Lead clinical and/or patient advisory board meetings to obtain strategic input into clinical program development
Serve as clinical and medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and business development and investor contacts
Provide clinical input on licensing opportunities
Required Knowledge, Skills, and Abilities
Demonstrated scientific and therapeutic experience
Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
Experience in leading the design, conduct, analysis, and reporting of clinical studies, including interactions with regulatory agencies
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
Leadership potential
Ability to work proactively and effectively using creative problem solving skills
Track record of relevant scientific publications
Travel required (up to 20%-30% of the time)
Required/Preferred Education and Licenses
MD or MD, PhD or equivalent with 3 to 5 years of relevant experience
Board certification in Oncology
At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive.
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: $240,000.00 - $360,000.00
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: https://careers.jazzpharma.com/benefits.html.