Clinical Development Scientist - Phanes Therapeutics Inc

Position: Clinical Development Scientist

Function: Clinical Development and Operations

Company: Phanes Therapeutics, Inc.

Location: San Diego, CA

Phanes Therapeutics is a clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA recently: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC).  In addition, both PT886 and PT217 have received Orphan Drug and Fast Track designations 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.

Job Summary:

The position is on-site full time. This position is in the clinical development team located at our R&D site in San Diego, CA. The candidate should have solid training and/or broad experience in a scientific discipline. Under the supervision of the Clinical Development Director, the candidate will provide scientific support in all aspects of the clinical programs, such as literature review, scientific writing, data analysis, presentation, and summary. This candidate will be a resource to teams for guidance of 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.

Key Responsibilities:

• Clinical Strategy:

• Integrate scientific knowledge and clinical data, in adherence with the Clinical Development Plan, to ensure translation of clinical research plans into high quality studies.
• Provide clinical support and scientific opinion to study teams.
• Provide input on clinical trial documents, milestones and timelines.
• Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment, including performing rigorous literature reviews.
• Stay abreast of internal and external developments, the competitive landscape, trends, and other dynamics relevant to the work, to maintain a fully current view.

• Data Analysis:

• Analyze, review, and curate key clinical trial data in a timely manner.
• Organize and manage key clinical trial data.
• Contribute to the ongoing scientific review of clinical trial data.

• Presentation and Documentation:

• Review, analyze, evaluate and interpret results of clinical trial data for internal and external presentation (including external partners and stakeholders, including clinical investigators, study coordinators/CRAs and KOLs), and regulatory submission.
• Involve in the development of clinical research protocols, ICFs, pharmacy manuals, lab manuals and regulatory submission documents.
• Assist in the generation of Clinical Development Plans, and adherence to plans.
• 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.

Qualifications:

1. An advanced degree in a related Life Sciences discipline (e.g. Pharm D, PhD, or MD) is preferred.
2. Proven track record of scientific publications.
3. Ability to understand and critically evaluate scientific literature.
4. Working knowledge of Microsoft suite of software products is required.
5. Ability to work in a highly collaborative, matrix environment, with cross-functional teams. Excellent problem-solving skills, a strong sense of urgency and keen attention to detail.
6. Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures.
7. Excellent oral and written communication skills and strong organizational skills are required.
8. Prior experience in Biotech or Pharmaceutical industry in clinical development with previous experience as in clinical development or as a clinical scientist is preferred.
9. Prior oncology or cancer biology experience is highly preferred. Experience in translational medicine/clinical research/early phase clinical trials is a plus.
10. Experience of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations is a plus.
11. Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.

Our Benefits Include:

• Competitive compensation package including bonus opportunities and stock options opportunities
• Exceptional career growth opportunities
• Excellent medical, dental and vision plans
• Generous vacation and sick leave plans
• 16 paid company holidays per year plus flexible floating holidays
• An opportunity to do truly meaningful work to make a lasting impact
• On-site gym, ample parking including complimentary EV charging stations, company-sponsored events, etc.
• Flexible spending accounts (FSAs) for eligible out-of-pocket health care and dependent day care expenses
• Health savings accounts (HSAs) a trust or custodial account to pay or reimburse certain medical expenses
• Life and AD&D insurance, short and long term disability plans
• Employee assistance program (EAP) provides employee counseling programs and various online resources
• Additional voluntary benefits including pet insurance, auto and home insurance, commuter benefits, legal plans, and more

The annual base salary we reasonably expect to pay is $110,000.00 - $170,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.