Erasca

Sr/Exec Director Clinical Development

operationsfull-timeSan Diego, CA or remote

SALARY

$265k – $310k/yr

WORK TYPE

remote

JOB TYPE

full-time

INDUSTRY

healthcare

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About the role

<div class="content-intro">Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s&nbsp;most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.</div>Position Summary: &nbsp;

Reporting to the&nbsp;Chief Medical Officer, the&nbsp;Senior&nbsp;or Executive&nbsp;Director, Clinical&nbsp;Development will&nbsp;drive the clinical aspects of late-stage clinical development studies or programs.&nbsp;This person will&nbsp;work closely with&nbsp;cross-functional teams&nbsp;in the management and execution of the<span data-ccp-charstyle="wbzude" data-ccp-charstyle-defn="{&quot;ObjectId&quot;:&quot;9bd681c4-55f3-5d6c-b9ee-54bcbe8d6169|1&quot;,&quot;ClassId&quot;:1073872969,&quot;Properties&quot;:[201342446,&quot;1&quot;,201342447,&quot;5&quot;,201342448,&quot;1&quot;,201342449,&quot;1&quot;,469777841,&quot;Calibri&quot;,469777842,&quot;Arial&quot;,469777843,&quot;Calibri&quot;,469777844,&quot;Calibri&quot;,201341986,&quot;1&quot;,469769226,&quot;Calibri,Arial&quot;,268442635,&quot;22&quot;,469775450,&quot;wbzude&quot;,201340122,&quot;1&quot;,134233614,&quot;true&quot;,469778129,&quot;wbzude&quot;,335572020,&quot;1&quot;,469778324,&quot;Default Paragraph Font&quot;]}">&nbsp;Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and&nbsp;in&nbsp;ensuring the successful execution and completion of clinical trials.&nbsp;The Senior&nbsp;or Executive&nbsp;Director, Clinical&nbsp;Science will&nbsp;also&nbsp;have individual study level responsibility&nbsp;for one or more trials.&nbsp;

Essential Duties and Responsibilities:&nbsp;&nbsp;

<ul>

<li>Lead in the planning and execution of clinical studies to successfully move the program through pivotal trials&nbsp;and&nbsp;eventual submission, regulatory approval, and launch.&nbsp;</li>

<li>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.&nbsp;</li>

<li>May attend and contribute&nbsp;at&nbsp;meetings with Health Authorities (HAs) related to program; develop&nbsp;responses to HAs and IRBs on clinical/medical questions.&nbsp;</li>

<li>Represent Erasca externally at scientific meetings and congresses.&nbsp;</li>

<li>Establish and&nbsp;maintain&nbsp;strong relationships with internal teams, clinical investigators, regulatory agencies, and key stakeholders.&nbsp;</li>

<li>Gather,&nbsp;analyze&nbsp;and interpret clinical data,&nbsp;providing&nbsp;strategic insights to inform critical decisions and guide program development.&nbsp;</li>

<li>Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.&nbsp;</li>

<li>Perform all duties in keeping with the Company’s core values,&nbsp;policies,&nbsp;and all applicable regulations.&nbsp;</li>

</ul>

Required Education and Experience:&nbsp;

<ul>

<li>Undergraduate degree&nbsp;required;&nbsp;PhD, PharmD, or other relevant advanced degree in a health science field&nbsp;highly preferred.&nbsp;</li>

<li>At least&nbsp;10&nbsp;years of biotech or pharmaceutical industry experience as a clinical scientist or in a&nbsp;closely&nbsp;related clinical development function.&nbsp;</li>

<li>Extensive experience in oncology clinical trials&nbsp;required;&nbsp;late-stage&nbsp;development experience&nbsp;required,&nbsp;early development&nbsp;experience&nbsp;a plus.<span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:259,&quot;335559991&quot;:360}">&nbsp;</li>

<li>Experience leading clinical development contributions to regulatory submissions (e.g. (NDA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) highly preferred.<span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:259,&quot;335559991&quot;:360}">&nbsp;</li>

<li>Experience in dynamic&nbsp;start&nbsp;up or small company environments&nbsp;required.&nbsp;</li>

<li>Demonstrated ability to contribute to strategic clinical planning and work effectively independently and on cross-functional teams.&nbsp;</li>

<li>Demonstrated ability to evaluate, interpret, and present complex scientific data.&nbsp;&nbsp;</li>

<li>Deep&nbsp;knowledge of biostatistics, GCP, and regulatory requirements for clinical studies;&nbsp;extensive&nbsp;experience with data analysis and interpretation;&nbsp;understanding of safety and pharmacovigilance principles.&nbsp;</li>

<li>Excellent verbal and written communication and presentation skills.&nbsp;</li>

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