Position: Executive Director, Clinical Development Oncology
Function: Clinical Development
Company: Phanes Therapeutics, Inc.
Location: San Diego, CA
Phanes Therapeutics is an emerging leader in innovative discovery research and clinical development in oncology. The company received two IND clearances from the FDA in the first half of this year, one (PT199) for solid tumors and another (PT886) for pancreatic, GEJ and gastric cancers. A third program from the company (PT217) has just received orphan drug designation from the FDA. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.
At Phanes, we understand that scientific innovation is a challenging task and that’s why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where individuals can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people. We offer competitive compensation and excellent medical, dental and vision benefits, and excellent career growth opportunities.
This position is in the clinical development and operations function located at our R&D site in San Diego, CA. The candidate should have solid training and/or broad experiences in oncology clinical development, The candidate will work with project teams to advance novel preclinical lead molecules into the clinic and will provide scientific guidance and support in all aspects of the clinical program such as study design, development, execution, data readout, and summary. This candidate will also be a resource to teams for guidance of all matters related to analysis and communication of clinical data. In addition, the candidate is expected to be skillful in integrating information from various functions and be articulate in communicating company clinical development strategy to internal and external stakeholders.
The candidate must be a team player and is expected to work with other scientific and clinical staff in advancing our programs through the clinic. Leadership skills in managing internal and external projects are required. Compensation will be commensurate with experience and skillset.
- Provide clinical development support and scientific opinion to study teams.
- Responsible for the research and development of clinical trial study designs.
- Drive contribution of clinical content for deliverables in support of regulatory submission activities and ensure flow and accuracy of key data for clinical module sections of the IND.
- Serve as a Study Medical Monitor, authoring clinical trial documents including protocols, investigator brochures, ICFs, training materials, and DSURs.
- Work closely with Clinical Operations and CROs to execute clinical trials with high quality and according to timelines.
- Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plans.
- Contribute to the ongoing scientific review of clinical trial data and assist with query generation/resolution and data analysis. Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data.
- Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Stay abreast of internal and external developments, trends, and other dynamics relevant to the work to maintain a fully current view.
- Develop and maintain relationships with a variety of internal and external partners and stakeholders, including clinical investigators, study coordinators/CRAs and KOLs.
- Review and manage clinical development budgets and provide forecasts to the clinical development and finance team members.
- Medical Degree (MD or DO) preferably board certified in medical oncology.
- 10+ years’ experience in clinical development with at least 5 years in the biopharmaceutical industry. Experience in translational medicine/early phase oncology clinical trials is a plus.
- Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations
- Proven ability to interact and work with external partners (CROs and consultants) with regards to clinical development functions.
- A solid understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management, and monitoring of CRO and investigative sites, IP accountability, database locks etc.
- Excellent problem-solving skills, a strong sense of urgency and keen attention to detail. Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures.
- A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required.
- Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct.
- Excellent oral and written communication skills and strong organizational skills are required. Highly experienced in utilizing CTMS, EDC, TMF and related software.
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.