Director, Clinical Development
The Director, Clinical Development, will join a growing team in the therapeutic areas of Neuroscience. Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials (if MD), contributing to CNS clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams within R&D.
Essential Functions:
- Provide leadership and medical/scientific input for clinical programs, clinical protocols in development, ongoing clinical trials (Phase 2, Phase 3), clinical study reports and regulatory documents.
- Serve as medical monitor on trials for products under development in CNS/neurology (if MD or appropriate per role).
- Provide clinical oversight during clinical programs and make recommendations based on findings to team, as needed.
- Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities in CNS.
- Collaborate closely within clinical development and with cross-functional team members including in clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of phase 2 and phase 3 clinical trials and programs.
- Collaborate closely with study investigators on clinical trial eligibility and subject and patient safety issues.
- Engage external experts to obtain scientific input into clinical program development.
- Prepare clinical data and clinical program presentations.
- Review, interpret, and approve safety and efficacy data in clinical study reports, regulatory documents and submissions related to clinical trials (e.g., IND and NDA).
- Review publication-related materials on Jazz Pharmaceuticals sponsored studies.
Required Knowledge, Skills, and Abilities:
- Clinical/scientific research experience required, with neuroscience expertise, epilepsy expertise preferred.
- Experience working in a pharma/biotech company, CRO, or other clinical research related vendor preferred.
- Ability to effectively lead cross functional teams and successfully leverage internal and external partnerships.
- Experience in preparation of regulatory submissions (INDs and NDAs) to US and European regulatory agencies.
- Lead preparation of clinical portions of relevant regulatory documents.
- Excellent oral and written communication skills.
- Knowledge of GCP, drug safety, MedDRA safety coding, and pharmacovigilance processes (as appropriate per role).
- Collaborative and flexible in personal interactions at all levels of the company.
- Ability to train other physicians/scientists a plus.
- Ability to work proactively and effectively, with demonstrated creative problem solving skills.
- Travel required (up to 5-20% of time)
Required/Preferred Education and Licenses:
- Medical degree, MD or advanced degree in biological sciences e.g. PhD or Pharm D with drug development experience in Neuroscience, experience in epilepsy is highly advantageous.
- Board Certification in Neurology, or equivalent CNS training is required.
- US licensure and/or clinical practice experience preferred.
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: $196,000.00 - $294,000.00 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.
Director, Clinical Development
The Director, Clinical Development, will join a growing team in the therapeutic areas of Neuroscience. Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials (if MD), contributing to CNS clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams within R&D.
Essential Functions:
- Provide leadership and medical/scientific input for clinical programs, clinical protocols in development, ongoing clinical trials (Phase 2, Phase 3), clinical study reports and regulatory documents.
- Serve as medical monitor on trials for products under development in CNS/neurology (if MD or appropriate per role).
- Provide clinical oversight during clinical programs and make recommendations based on findings to team, as needed.
- Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities in CNS.
- Collaborate closely within clinical development and with cross-functional team members including in clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of phase 2 and phase 3 clinical trials and programs.
- Collaborate closely with study investigators on clinical trial eligibility and subject and patient safety issues.
- Engage external experts to obtain scientific input into clinical program development.
- Prepare clinical data and clinical program presentations.
- Review, interpret, and approve safety and efficacy data in clinical study reports, regulatory documents and submissions related to clinical trials (e.g., IND and NDA).
- Review publication-related materials on Jazz Pharmaceuticals sponsored studies.
Required Knowledge, Skills, and Abilities:
- Clinical/scientific research experience required, with neuroscience expertise, epilepsy expertise preferred.
- Experience working in a pharma/biotech company, CRO, or other clinical research related vendor preferred.
- Ability to effectively lead cross functional teams and successfully leverage internal and external partnerships.
- Experience in preparation of regulatory submissions (INDs and NDAs) to US and European regulatory agencies.
- Lead preparation of clinical portions of relevant regulatory documents.
- Excellent oral and written communication skills.
- Knowledge of GCP, drug safety, MedDRA safety coding, and pharmacovigilance processes (as appropriate per role).
- Collaborative and flexible in personal interactions at all levels of the company.
- Ability to train other physicians/scientists a plus.
- Ability to work proactively and effectively, with demonstrated creative problem solving skills.
- Travel required (up to 5-20% of time)
Required/Preferred Education and Licenses:
- Medical degree, MD or advanced degree in biological sciences e.g. PhD or Pharm D with drug development experience in Neuroscience, experience in epilepsy is highly advantageous.
- Board Certification in Neurology, or equivalent CNS training is required.
- US licensure and/or clinical practice experience preferred.
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: $196,000.00 - $294,000.00 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.
