SVP Biometrics

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 theSVPBiometricswill be accountable for biometrics activities for all programs from IND-enabling to registration and launch. This includes leadership ofthe Biostatistics Statistical Programming& Analysis and Clinical Data Management functions. This role requires hands-on execution as well as oversight of internal and external addition this person willrepresentthe Biometrics functionon the Erasca leadership teamand in cross-functional discussions and decision ideal candidate will haveexcellenttechnical skillsa track recordof developing and mentoring strong teamssignificantexperiencein all phases ofoncologydrug developmenta track recordof successful regulatory interactions and excellent communication skills and executive presence.

EssentialDuties andResponsibilities:

• Buildmaintainand develop a high performing team across Biostatistics Statistical Programming& Analysis and Clinical Data Management.
• Ensure systems capabilities and resources are in place thatoptimizethe design conductanalysisand interpretation of clinical and nonclinical data forallprograms.
• Demonstrate technical excellencedelivering advanced biometric strategies across the portfolio.
• Act as the subject matter expert for biometricsadvisingsenior management development and clinical operations teams on current biostatisticsmethodologyand tools in drug development.
• In collaboration withVP Biostatistics ensure statistical analysis and submission datasets meet regulatory requirements.
• In collaboration with VP StatisticalProgramming & Analysis ensure the intended analyses are performed andanalysisdata sets and their specifications are in place.
• In collaboration with Sr Director Clinical Data Managementprovidesupport to clinical study teams on the collectioninterpretationand reporting of clinical data.
• Provide input on key development documents clinical protocols study reports IBs INDs NDAs and labeling for all products.
• Support preparations for interactions with regulatory agencies and provide guidance to ensure high quality preparation of Regulatory Authority documents (clinical study reports submissions clinical protocols safety reports etc.). Represent biometrics in interactions with regulatory agencies and health authorities.
• Review and comment on eCRFs annotated eCRFs edit checks documents and other clinical data management related documents.
• Stay abreast of emerging technologies and concepts related to applied statisticalmethodology.
• Lead biometrics due diligence in support of business and corporate development activities.
• Establish and further embedbiometricsSOPs processes and relevant quality managementsystem.
• Ensureappropriate resourcingof the biometrics organization byanticipatingneeds and filling gaps as needed with consultantscontractorsand/or employees.
• Mentor and promote the professional development of Biometrics team members.
• Up to 25% travel may bepossible international travel.
• Perform all duties in keeping with the Companys core valuespoliciesand all applicable regulations.

Required Education and Experience:

• Minimum of 15yearsrelevant experience in the pharmaceutical or biotechnology industry ideally including both large and small company experience.
• PhD degree in statisticsorbiostatistics.
• Ahandson and flexible leader comfortable as a subject matter expert for biometricsas well as contributingatthe leadership team and leading and managing highly accomplished function managers.
• Experience in oncology drug development ideally from FIH to registration.
• Direct experience leading and working in Biostatistics requiredas well asexperience leading Statistical Programming and/or Clinical Data Management.
• Extensive knowledge of clinical researchmethodologyand regulatory requirements as they relate to trial design and analysis.
• Good knowledge of ICH FDA and GCP regulations and guidelines;strongwell-rounded technicalskill SAS SDTM and CDISC.
• Extensive experience negotiating successfully with health authorities.
• Excellent analytical and organizational skills.
• Track record of successfully working within individual protocols and across programs to design drive and execute statistical strategy.
• Proven ability to attract develop and manage top notch talent including a mix of internal and contingent staff.
• Highly collaborative team player who fosters open communication andfacilitatesmutual understanding and cooperation between all stakeholders.
• Executive leadership skills to educate and influence stakeholders and to add valueinstrategic business planning and decision-making.
• Effective interpersonal communication and influencing skills including strong writing and presentation 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.
• Strong learning orientation curiosity andcommitment to science and patients.

The anticipated salary range for this position is $350000 to $415000. 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.