SVP Late Clinical Development
San Diego, CA - USA
Job Summary
Erascais 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 cancersmost 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.
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 addition the SVP will be a handson 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.
Essential Duties and Responsibilities:
- Providemedical direction and high-quality scientific and clinical knowledge to guide the strategy and execution oflate-stageclinicalprogramsandcontribute to clinical decision making across the inbuildingandmaintaininga culture of rigorous data-driven decision making.
- Lead late clinical development function directly and through reports.
- 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.
- Serve as Medical lead on clinical programs and represent Clinical Development on program teams.
- Design and implementnovel and efficientregistration enablingclinical trialstoassessappropriate endpoints.
- Responsible for leading clinical studysubteamsmonitoringoverall study integrity and review interpretationand communication of safety and efficacy data.
- In collaboration with head of MedicalAffairscontinue the establishment and execution of medical affairs strategy and tactics.
- Contribute to regulatory filings including authoring clinical sections for NDAs and other related documents.
- Partner with Drug Safety to assess the safety profile of compounds.
- Write medical aspects of core study and regulatory documents including clinical research plans protocols investigator brochures clinical studyreportsand regulatory submissions.
- Contribute to the development and review of scientific publications; author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication planobjectives.
- Present at scientific medicaland regulatory meetings.
- Maintaina high levelof clinical and scientificexpertiseby reviewing literature attending medicalorscientific meetingsand through personalexchangewiththought leaders investigatorsand internal stakeholdersand partners.
- Participate in due diligence or other business development activities.
- Recruitretain and develop high-functioning late clinical development team.
- Establish developandmaintainrelationships across Erasca particularly with partners and stakeholders inResearch andDevelopment.
- Perform all duties in keeping with the Companys core valuespoliciesand all applicable regulations.
Required Education and Experience:
- equivalent with subspecialtyfellowshiptraining and board certification or eligibility in Oncology or Oncology/Hematology.
- 12years ofoncologyclinical trial anddrug development experienceincluding extensive experience in the pharmaceutical or biotechnology ideal candidate will bringa combination of clinical practice academic clinical trialsand industry experiencewithbothlarge and small companyexperiencea plus.
- Direct management of medical and scientific staff in clinical developmentrequired;experienceleadingmedical affairsfunctionhighly preferred.
- Experience as the clinical lead on complicated global programs with multiple indications and studiesrequired.
- Experience leading or beingclosely involvedinthe clinical aspects of aregulatory filing and direct interaction with health authoritiesrequired.
- Experience with product launch and commercialization highly preferred.
- Experienceinearly developmenta plus.
- Extensive knowledge of clinical trialmethodologyand theregulatory and compliance requirements governing clinical trials.
- Executive leadership skills torepresentlate development on LT educate and influence stakeholders and add value in strategic business planning and decision-making.
- Demonstrated ability to collaborate successfully with multiple functions in amatrixedteam environment.
- Effective interpersonal communication and influencing skills including excellent writing skills with the ability to tailor communication style to diverse audiences and situations.
- 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 toidentifyand implement creative solutions to complex problems.
- Strong learning orientation curiosity andcommitment toscience and patients.
The anticipated salary range for this position is $400000 to $465000. 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.
Along with our casual collaborative and fun work and the chance to make your mark in our mission to erase cancer Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off Holiday and Sick Leave Medical Dental and Vision Plans Short- and Long-Term Disability Basic and Voluntary Life/AD&D Coverage Flexible Spending Accounts (FSA HSA and Commute) Critical Illness and Accident Coverage Pet Insurance Employee Assistance Program 401(k) Plan with Erasca contribution and the opportunity to participate in an Employee Stock Purchase Program.
Erasca Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of sex race religion national origin ancestry physical or mental disability protected medical condition genetic information marital status registered domestic partner status age sexual orientation military and veteran status or any other basis protected by federal state or local law or ordinance or regulation.
Required Experience:
Senior Exec
About Company
Erasca is a clinical-stage precision oncology company driven by a bold mission—to erase cancer. We are on a journey to shut down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. Our promi ... View more