Description
Associate Director / Director, Clinical Science
Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted 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.
Our Associate Director / Director, Clinical Science, will be a key contributor to the clinical development programs. She or he will be responsible for directing the planning and execution of one or more clinical programs including our MDM2 inhibitor, Rain-32, for patients with well-differentiated liposarcoma. The Associate Director / Director, Clinical Science, will work in collaboration with regulatory, clinical operations, quality, manufacturing, and other cross-functional team members and report to the Chief Medical Officer.
Key Requirements:
- Design, manage, and support all of Rain's clinical program activities and objectives
- Develop and write essential documents including study designs and protocols
- Review, analyze, interpret, and present clinical data to internal and external stakeholders and prepare study abstracts and manuscripts
- Select optimum CRO partners and ensure an effective relationship with the Rain clinical study support team
- Serve as the primary contact for IRB and study investigator inquiries
- Lead essential FDA and OUS regulatory requirements and guidelines
- Establish and maintain effective KOL and investigator relationships and communication including Advisory Board meetings.
- May be assigned other projects and duties as required
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Required Education and Experience:
- Bachelor's degree required, PhD, PharmD, or MS degree preferred
- 2+ years of relevant biopharmaceutical clinical trial experience in oncology-focused drug development required
- Strong knowledge of FDA and US regulatory requirements and guidelines
- Extensive experience in all phases of clinical development required and previous experience with oncology and small molecules preferred
- Strong record of successfully delivering clinical projects on time and on budget
- Demonstrated leadership in affecting a productive work environment and alignment of internal and external partners
- Work without close supervision both independently and as part of a team
- Previous experience working in a startup or fast-paced, dynamic environment
- Able to solve problems under pressure
- Travel domestically and internationally as required to carry out responsibilities.
- Must have excellent interpersonal, written and verbal communication skills
- Strong computer experience and demonstrated proficiency in MS Office (Outlook, G-Suite, MS Word, Excel, PowerPoint)
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.
