Erasca

SVP Late Clinical Development

operationsfull-timeSan Diego, CA or remote

SALARY

$400k – $465k/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>Reporting to the Chief Medical Officer, the SVP Late Clinical Development will provide medical leadership and oversight of late-stage clinical trials and collaborate with the CMO across the Erasca portfolio. In addition, the SVP will be a hands–on drug developer and will serve as clinical lead and/or medical monitor on programs or studies. A key area of focus will be the design and execution of multiple registration enabling trials in solid tumor indications.&nbsp;

Essential Duties and Responsibilities:&nbsp;

<ul>

<li>Provide&nbsp;medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of&nbsp;late-stage&nbsp;clinical&nbsp;programs&nbsp;and&nbsp;contribute to clinical decision making across the Erasca&nbsp;portfolio.&nbsp;Participate in&nbsp;building&nbsp;and&nbsp;maintaining&nbsp;a culture of rigorous data-driven decision making.&nbsp;</li>

<li>Lead late clinical development function, directly and through reports.&nbsp;</li>

<li>Responsibilities will include clinical development strategy, protocol development, registrational strategy, KOL and academic site interactions, competitive landscape diligence, presentation of data, and other clinical deliverables.&nbsp;</li>

<li>Serve as Medical lead on clinical programs and represent Clinical Development on program teams.&nbsp;</li>

<li>Design and implement&nbsp;novel and efficient&nbsp;registration enabling&nbsp;clinical trials&nbsp;to&nbsp;assess&nbsp;appropriate endpoints.&nbsp;</li>

<li>Responsible for leading clinical study&nbsp;subteams,&nbsp;monitoring&nbsp;overall study integrity, and review, interpretation,&nbsp;and communication of safety and efficacy data.&nbsp;</li>

<li>Contribute to regulatory filings including authoring clinical sections for NDAs and other related documents.&nbsp;</li>

<li>Partner with Drug Safety to assess the safety profile of compounds.&nbsp;</li>

<li>Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study&nbsp;reports&nbsp;and regulatory submissions.&nbsp;&nbsp;</li>

<li>Contribute to the development and review of scientific publications; author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan&nbsp;objectives.&nbsp;&nbsp;</li>

<li>Present at scientific, medical,&nbsp;and regulatory meetings.&nbsp;</li>

<li>Maintain&nbsp;a high level&nbsp;of clinical and scientific&nbsp;expertise&nbsp;by reviewing literature, attending medical&nbsp;or&nbsp;scientific meetings,&nbsp;and through personal&nbsp;exchange&nbsp;with&nbsp;thought leaders, investigators,&nbsp;and internal stakeholders&nbsp;and partners.&nbsp;</li>

<li>Participate in due diligence or other business development activities.&nbsp;</li>

<li>Recruit,&nbsp;retain, and develop high-functioning late clinical development team.&nbsp;</li>

<li>Establish, develop,&nbsp;and&nbsp;maintain&nbsp;relationships across Erasca, particularly with partners and stakeholders in&nbsp;Research and&nbsp;Development.&nbsp;&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>M.D.&nbsp;degree&nbsp;or equivalent, with subspecialty&nbsp;fellowship&nbsp;training and board certification or eligibility in Oncology or Oncology/Hematology.&nbsp;&nbsp;&nbsp;</li>

<li>12+&nbsp;years of&nbsp;oncology&nbsp;clinical trial and&nbsp;drug development experience,&nbsp;including extensive experience in the pharmaceutical or biotechnology industry.&nbsp;The ideal candidate will bring&nbsp;a combination of clinical practice, academic clinical trials,&nbsp;and industry experience,&nbsp;with&nbsp;both&nbsp;large and small company&nbsp;experience&nbsp;a plus.&nbsp;&nbsp;</li>

<li>Direct management of medical and scientific staff in clinical development&nbsp;required.&nbsp;</li>

<li>Experience as the clinical lead on complicated global programs with multiple indications and studies&nbsp;required.&nbsp;</li>

<li>Experience leading or being&nbsp;closely involved&nbsp;in&nbsp;the clinical aspects of a&nbsp;regulatory filing and direct interaction with health authorities&nbsp;required.&nbsp;&nbsp;</li>

<li>Experience with product launch and commercialization highly preferred.&nbsp;</li>

<li>Experience&nbsp;in&nbsp;early development&nbsp;a plus.&nbsp;</li>

<li>Extensive knowledge of clinical trial&nbsp;methodology&nbsp;and the&nbsp;regulatory and compliance requirements governing clinical trials.&nbsp;&nbsp;</li>

<li>Executive leadership skills to&nbsp;represent&nbsp;late development on LT, educate and influence stakeholders, and add value in strategic business planning and decision-making.&nbsp;</li>

<li>Demonstrated ability to collaborate successfully with multiple functions in a&nbsp;matrixed&nbsp;team environment.&nbsp;</li>

<li>Effective interpersonal, communication and influencing skills, including excellent writing skills, with the ability to tailor communication style to diverse audiences and situations.&nbsp;&nbsp;</li>

<li>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&nbsp;identify&nbsp;and implement creative solutions to complex problems.&nbsp;</li>

<li>Strong learning orientation, curiosity, and&nbsp;commitment to&nbsp;science and patients.&nbsp;</li>

</ul>

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