Description
Senior Director, Clinical Science
Position Summary:
Reporting to the SVP Early Clinical Development, the Senior Director, Clinical Development will support and may lead the clinical aspects of one or more clinical development studies. This person will work closely with cross-functional teams in the management and execution of the Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and in ensuring the successful execution and completion of clinical trials. The Senior Director, Clinical Science will also have individual study level responsibility for one or more trials.
Essential Duties and Responsibilities:
- Key clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review, and other deliverables as needed.
- May attend and contribute at meetings with Health Authorities (HAs) related to program; develop responses to HAs and IRBs on clinical/medical questions.
- Represent Erasca externally at scientific meetings and congresses.
- In collaboration with other functions and stakeholders, continue to create functional policies and procedures to provide strong and efficient clinical development processes that are scalable and fit for purpose.
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Required Education and Experience:
- Undergraduate degree required; PhD, PharmD, or other relevant advanced degree in a health science field highly preferred.
- At least 10 years of biotech or pharmaceutical industry experience as a clinical scientist or in a closely related clinical development function.
- Experience in oncology clinical trials required; early development experience required, late-stage experience a plus.
- Extensive experience in dynamic start up or small company environments required.
- Demonstrated ability to contribute to strategic clinical planning and work effectively independently and on cross-functional teams.
- Demonstrated ability to evaluate, interpret, and present complex scientific data.
- Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles.
- Proven track record of successfully delivering projects on time, to budget and required quality.
- Excellent verbal and written communication and presentation skills.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.
- Flexibility, with the willingness and ability to manage through strategic shifts.
- Strong learning orientation, curiosity, and passion for science and patients.
The anticipated salary range for this position is $200,000 to $275,000. 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, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.
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