Clinical Development Director Vaccines
Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients.
THE OPPORTUNITY
Major areas of responsibility include: design and ownership of the clinical development plan, clinical expert liaison and management, clinical trial design, medical monitoring of Arcturus-sponsored clinical trials (if medically qualified), clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications and presentations on the area of interest, prepare/revise/maintain and efficiently execute the clinical development strategy.
Reporting to the VP of Vaccines Clinical Development, the (Associate/Senior) Clinical Development Director (CDD) is responsible for assisting (Associate/Director) or leading (Senior) in the strategic planning and the day-to-day management of the assigned clinical program(s) from an end-to-end clinical development perspective. As (Associate/Director/Senior) CDD, you will have oversight of the clinical development for the assigned clinical study/ies and drive execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
WHAT YOU WILL CONTRIBUTE
- Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
- Leading development of clinical sections of trial and program level regulatory documents
- Driving execution of the clinical program in partnership with Clinical Operations, Program Management, Bioanalytical, Biometrics, Regulatory, Clinical Trial Supply functions and outsourced Development functions, Clinical Research Organizations
- Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead. This includes accountability for the interpretability (characterization of safety and efficacy), reportability (emerging issues), accuracy of emerging study data.
- Contributes to efforts chaired by Clinical Operations and Project Management for ensuring GCP-compliant oversight of the clinical trials, clinical research organization, trial-related budget development and oversight.
- Supporting Pharmacovigilance in ensuring overall safety of the vaccine and may be a core member of the Safety Management Team, supporting overall program safety reporting
- As a clinical expert, supporting the VP Clinical Development and the Chief Development Officer in interactions with external and internal stakeholders and decision boards
- Contributing to scientific training of relevant stakeholders on the disease area and vaccine.
- May serve as speaker for the franchise medical/scientific training.
WHAT WE SEEK
- Advanced degree in life sciences / healthcare (or clinically relevant degree) is required.
- MD is strongly preferred. PharmD or PhD may be considered.
- Minimum requirement for years of experience in clinical research or drug development will be commensurate to level. (Assoc. CDD 2 years, CDD 3 years, Senior CDD 5 years)
- Working knowledge of vaccines is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
- Demonstrated ability to establish effective working relationship with key investigators
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Strong communication skills with the ability to work in a cross functional and global organization required.
- Experience contributing to IND/BLA preferred
EDUCATION
- Advanced degree in life sciences / healthcare (or clinically relevant degree) is required.
- MD is strongly preferred. PharmD or PhD may be considered.
WHAT WE OFFER
At Arcturus Therapeutics, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family, and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Our total rewards package includes:
- Full range of health benefits including Medical, Dental & Vision with 100% EMPLOYER PAID premiums for employee and family!
- 401k Match
- Employee Stock Purchase Program (ESPP)
- Competitive salaries and bonus plans plus equity via Stock Options
- Catered lunches
- Free variety of snacks and beverages
- Health and Wellness programs
- $100 Anniversary cash awards with opportunity to increase to $2000!
- Referral Bonuses
- On Campus Gym
- Company sponsored FUN events
- Education reimbursement
- The anticipated salary range for candidates who will work in San Diego is $198,000.00 to $230,000.00.
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Arcturus Therapeutics is multi state employer and this salary range may not reflect positions that work in other states. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
For a deeper dive into our company and corporate culture visit www.ArcturusRx.com