Medical Director / Senior Medical Director

Santa Monica

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, preclinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

The Medical Director is responsible for the oversight, execution, and management of clinical trials for our innovative pipeline of early-stage adoptive T cell therapies. These capabilities may include, but are not limited to medical monitoring, data review and development of documents

This position is based in Santa Monica, CA, and reports to the Vice President of Clinical Development.

Responsibilities include, but are not limited to:

This role will comprise multiple critical functions, including:

Provide medical monitoring to multiple oncology clinical trials.
Participate in and/or lead project teams to design and implement clinical studies.
Provide expert opinion and writing support for trial-related documents including protocols, investigator brochures, charters, clinical study reports and review of clinical trial documents.
Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
Help devise and execute development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
Translate findings from research and nonclinical studies into clinical development opportunities.
Work with internal teams and to apply regulatory guidelines relevant to the pharmaceutical industry and ensure compliance with these external guidelines.
Work with internal discovery scientists, translational scientists, technical operations/manufacturing teams, regulatory affairs, safety and pharmacovigilance, external consultants or CROs in a cross functional manner.
Perform other duties as required

Requirements:

The successful candidate will be a self-driven team player able to work effectively in a fast-paced small biotechnology environment.
Candidates must be knowledgeable of clinical trial design and execution.
Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent the mission, goals and values of Neogene.
Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.
Demonstrated ability to work well in teams in a cross functional manner.
Ability to communicate and work independently with scientific/technical personnel with excellent written and oral presentation skills.
Ability to think critically and demonstrated troubleshooting and problem-solving skills.
Self-motivated and willing to accept temporary responsibilities outside of initial job description.
Comfortable in a fast-paced small company environment, with minimal direction and able to adjust workload based upon changing priorities.
Flexibility to travel up to 25% based on business needs.

Education and Experience

MD/DO degree with board certification/eligibility in Hematology and/or Oncology required. Experience managing oncology trials experience with cell therapy preferred.
At least 4 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience.
Experience designing, implementing, and carrying out hematology/oncology clinical trials, including knowledge of current hematology/oncology treatment landscapes.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to:

Sit and talk or hear
The employee frequently is required to use hands to finger, handle, or feel
The employee is occasionally required to stand, walk, and reach with hands and arms
The employee must occasionally lift and/or move up to 10 pounds
Specific vision abilities required by this job include close vision and ability to adjust focus in order to read
The noise level in the work environment is usually moderate

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Medical Director / Senior Medical Director

Education and Experience

Physical Requirements

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