Vice President Clinical Development

Location
Newark, CA
Posted
Oct 27, 2021
Ref
4098689004
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Vice President Clinical Development

Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate team of core scientific, clinical, regulatory, and business leaders to bring new therapies for cancer patients struggling with limited treatment options.  Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.

Rain Therapeutics strongly believes that we are tremendously fortunate to aim our careers towards having a direct impact on patients, and we intend to fully leverage this opportunity with aggressive developmental timelines for a multitude of pipeline programs, all unified across a precision oncology strategy. 

Summary:

The newly created opportunity of VP, Clinical Development is tailored for a physician who will provide strategic direction and technical leadership in the development and execution of clinical development plans for all drug candidates and will be instrumental in building the company's clinical development organization. This individual will have a track record of designing and executing robust clinical studies, leadership in providing expert input in scientific discussions, and proactive engagement in interactions with thought leaders, health authorities, and regulatory bodies. Depending on experience, the VP Clin Dev will have direct reports and will recruit, build, and lead a clinical operations team to facilitate the management of the clinical trial process, including planning and execution of in-house or outsourced clinical trials. The position reports directly to the CMO of Rain Therapeutics and will require approximately 20% domestic and international travel.

Critical Deliverables:

  • Drive the execution of the clinical program on a tumor agnostic biomarker-driven basket trial in solid tumors.
  • Lead the clinical review of data, including adverse events, efficacy, medical and correlative science, data query ration and resolution.
  • Spearhead the totality of the clinical regulatory strategy and execution of Rain’s programs, serving as the clinical lead of regulatory submissions, authoring clinical modules and clinical review of other modules
  • Lead protocol & CRF development, CRO selection, and investigator brochures
  • Oversee all medical data review and medical monitoring and develop oncology clinical study reports.
  • Manage the clinical development and operations budget, regularly report on the financial needs of the team, and coordinate with the Finance / Accounting team regularly for an up-to-date financial picture of the overall business
  • Execute and deploy drug development strategic plans, develop contingency plans, and provide technical and strategic advice to ensure milestones and timelines are being met with ample contingencies
  • Translate findings from research and nonclinical studies into clinical development opportunities; work with cross-functional team members to prepare manuscripts and external presentations.
  • Ensure compliance with ethical guidelines relevant to the pharmaceutical industry
  • Provide therapeutic area medical and scientific expertise to senior management and key stakeholders; attend key scientific congresses and meetings in support of speakers and key opinion leaders
  • Remain current in literature and emerging data of relevant therapeutic areas
  • Remain current with FDA and international regulatory guidance relevant to oncology and orphan drug development and participate in regulatory authority meetings as required

Education and Experience:

  • MD required with Oncology Fellowship; Board Certification or Board-eligible in Oncology or hematology
  • Minimum of 10 years’ experience in industry in drug development of Phase I – III studies in an oncology-focused drug development organization.
    • Experience to include all aspects of protocol conduct, both early and late phase, including protocol development, medical monitoring, start-up, study execution, analysis and reporting.
    • Experience to include working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials.
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral form
  • Comfortable working with small teams/small companies to execute on a clinical development strategy
  • Excellent presentation skills and poise speaking in public settings, comfortable as a representative of Rain Therapeutics to external stakeholders
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Strong critical, strategic, and analytical thinking skills to interpret data and develop written reports and presentations of those data

Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.