Medical Director, Clinical Development in Oncology - Phanes Therapeutics Inc

Position: Medical Director, Clinical Development in Oncology

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:

This position is on-site full time in San Diego, CA. The candidate should have solid training and/or broad experience in oncology clinical development. The candidate will work with clinical project teams to support medical aspects of the clinical programs, including medical monitoring, communication with principal investigators (PIs) on clinical trial sites, optimizing study designs, helping with data readout, reporting clinical trial data and presenting updates to the senior management. This candidate will also be a resource to teams on 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 executing the clinical programs. Compensation will be commensurate with experience and skillset.

Key Responsibilities:

• Serve as a Study Medical Monitor, authoring clinical trial documents including protocols, investigator brochures, ICFs, training materials, and DSURs.
• Provide clinical development support and scientific opinion to study teams.
• Contribute to the development and optimization of clinical trial study designs.
• Work closely with Clinical Operations to execute clinical trials with high quality, deliver results and meet target timelines.
• 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.
• 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.

Qualifications:

1. Medical Degree (MD or DO) preferably board certified in medical oncology.
2. 5+ years’ experience in clinical development with at least 2 years in the biopharmaceutical industry. Experience in translational medicine/early phase oncology clinical trials is a plus.
3. Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations.
4. Proven ability to interact and work with external partners (PIs and consultants) with regards to clinical development functions.
5. A solid understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management, and monitoring of investigative sites.
6. 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.
7. A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required.
8. Excellent oral and written communication skills and strong organizational skills are required.
9. 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 include pet insurance, auto and home insurance, commuter benefits, legal plans, and more.

The annual base salary we reasonably expect to pay is $215,000 - $300,000. 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.