Tallac Therapeutics™ is rapidly advancing novel therapies to help the patients most in need. We are proud to be a dynamic, science-driven team that embraces innovation and collaborates to do important work. Tallac provides excellent compensation and benefits. If you would like to join our team, please contact us at firstname.lastname@example.org
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This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs. This hire will report directly to the CMO.
Essential Functions of the Job (Key responsibilities)
- Design and author protocols and protocol amendments for clinical studies
- Responsible for providing clinical input into eCRF design, SAP, and TLFs
- Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends
- Provide clinical updates on assigned compounds/programs to Sr. management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees
- Lead or co-lead the ICF risk language across a compound to ensure a consistent approach
- Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
- Lead, co-lead, and contribute to the review of clinical sections of documents such as IND, IND amendments, Investigator Brochures, oncology unique CRFs, Annual Reports and other Health Authority submissions
- Manage relevant issue escalation to resolution, as items arise on Clinical Development Programs
- Coordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of content
- Attend and present at various meetings with internal and external stakeholders (e.g., investigator meetings, scientific advisory boards, etc.)
- Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategy
- Clinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compounds
- Maintain updated knowledge of competitive landscape of assets with similar MOA and/or evolving standards of care for indications of interest
- Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed
- Liaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicable
- Consult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgets
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Degree in scientific/life-sciences field (Masters, RN, MSN, Pharm.D, or Ph.D preferred)
- Minimum of 10 years of experience in research with at least 6 years of drug development experience are required.
- Prior Oncology Drug Development experience preferred
- Global oncology trial experience and Health Authority experience are preferred
- Excellent written and oral communication skills
- Strong analytical and strategic ability
- Ability to work independently and to multi-task large projects, ability to change pace and tasks as needed, and to work in a fast-paced environment
- Knowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelines
- Ability to manage direct reports a plus
- Ability to lead and/or be a proven leader in a line function responsibility
- Have proven ability to drive decisions and manage in difficult business situations
- Ability to accommodate up to 20% travel or as business dictates
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Tallac Therapeutics is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the U.S. To apply for this position, please send your cover letter and resume to email@example.com.