Sr Director, Clinical Development, Hematology-Oncology
Category: Research & Development| Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4288
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Senior Director, Clinical Development, will join a rapidly-growing team in the Hematology/Oncology Therapeutic Area. Responsibilities include clinical leadership of global clinical development plans and protocols to support new and existing programs; medical monitoring, scientific oversight, interpretation and dissemination of clinical trial data; support of regulatory interactions; building, maintaining, expanding and managing external relationships, and representing clinical development in cross-functional matrix teams within Jazz
- Provide leadership and medical input for clinical programs, clinical protocols in development, ongoing clinical trials, clinical study reports and regulatory documents
- Collaborate closely with team members in clinical development, operations, biostatistics, regulatory, pharmacovigilance, early development, and other functions to facilitate the execution of quality clinical trials and programs
- Serve as medical monitor on trials for products under development in Hematology/Oncology and make recommendations based on safety findings to team, as needed; collaborate closely with CRO and study investigators on clinical trial eligibility and subject and patient safety issues
- Review, interpret, and approve safety and efficacy data in clinical study reports, regulatory documents and submissions (e.g., IND and NDA)
- Provide strategic input on new product concepts, long-range strategic plans and life-cycle management opportunities
- Engage external experts to obtain scientific input and to integrate current clinical practice and guidelines into global clinical development plans, including relevant industry developments
- Build, maintain, expand and manage external relationships with outside collaborators and clinical investigators both in the US and EU/ROW (e.g. management of cooperative groups) to support the clinical development program
- Serve as clinical resource for issues raised by a range of collaborators, investigators, consultants and corporate/investor contacts
Required Knowledge, Skills, and Abilities
- 3+ years academic and/or pharmaceutical industry experience
- Demonstrated expertise in Hematology/Oncology global clinical development
- Excellent oral and written communication skills
- Knowledge of GCP, Drug Safety, MedDRA safety coding and Pharmacovigilance processes
- Values-based leadership evident in personal interactions at all levels of the company
- Proactive and effective work style, with creative problem-solving skills
- Ability to travel; over short periods of time, travel can be up to 30-40%.
Required/Preferred Education and Licenses
- Post-graduate degree is required
- MD or DO is preferred
- Board Eligibility/Certification in Hematology and/or Medical Oncology is preferred
- US licensure and/or clinical practice experience is 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.