Medical Director

Precision BioSciences is rapidly expanding as a company based on our exciting off-the-shelf allogenic cell therapies. We are already treating patients in a phase 1 study of PBCAR0191 (targeting CD19, https://www.clinicaltrials.gov/ct2/show/NCT03666000 ) and expect to initiate treatment of patients in two other phase 1 studies prior to mid-2020. To meet the growing need for clinical trial operational oversight, strategic trial design, vendor management, medical monitoring, and preparation for commercialization, we are searching for a talented physician with experience in oncology drug development, with a preference for those who have clinical experience in hematologic malignancies. Additional ideal characteristics include previous experience with immuno-oncology agents and/or cell-based therapies. Experience writing clinical trial protocols, trial oversight, data management, biostatistical analysis, data presentation/publication, and interaction with regulatory authorities are considered essential to the position.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

accountable for all activities of the operational study team and clinical trials to which you are assigned, including

• design of trials
• trial amendments
• regulatory interactions related to real time feedback from clinical sites and data from treated patients
• medical oversight of trial conduct
• data interpretation as appropriate
• execution of compassionate use approaches
• ascertaining the medical accuracy and fair balance of medical information in promotional and learning materials for both internal and external use

responsible for medical input into our larger cell therapy strategy, interacting with our basic research team, our regulatory affairs team, our manufacturing team, and our commercial team

responsible for interaction with external partners including academic advisors, regulatory consultants, clinical trial investigators and other site study staff, and vendors including contract research organizations

In the longer term, it is expected this role will require interaction with patient advocacy foundations and payer and provider groups as we move toward a commercial product

You may be asked to play a role in business development opportunities with potential partners

You will play an integral role in the planning and participation of scientific and medical advisory boards and in the planning and will be called upon for external communication in these settings as well as scientific meetings

As a medical expert, you will supply medical input into all programs with a focus on those to which you are primarily assigned

Finally, there is an opportunity to grow into a role that includes in vivo gene editing approaches that we plan to put into the clinic over the next year and beyond. These approaches require critical thinking and a willingness to identify new solutions to new problems. This area will not be the primary focus of this role, but the opportunity exists to play a key role if other job responsibilities are met.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

Graduate of an accredited medical school and recipient of M.D. or D.O. degree or equivalent

Minimum 3 years of pharmaceutical industry or other related areas of experience, including first-hand experience writing, editing, and finalizing documents related to clinical trials

Board certification/eligibility in internal medicine or a related relevant specialty, such as Oncology

Strong leadership with proven track record of change and impact

Proven ability to engage and influence senior stakeholders

Thorough understanding of drug development and pharmaceutical market support and in-depth knowledge of the Oncology with a focus on Hematology (clinical evidence and real-world patient management)

Proven ability to interact productively with both commercial and scientific colleagues

Demonstrated ability to work collaboratively in cross functional teams

Familiarity with key regulations in the pharmaceutical industry

Highest level of ethics and integrity

Ability to travel domestically and internationally up to ~30%

Experience with pharmaceutical drug development and Medical/Scientific Affairs

Preferred:

Active medical license

Additional training such as an M.P.H., M.B.A., or other advanced degree

Knowledge of relevant Professional Societies and Scientific Medical Experts

Background in practicing medicine, clinical research, and familiarity with biostatistics, epidemiology and health outcomes

Excellent written and oral communication, interpersonal, and organization skills

High level of emotional intelligence

Passion for patient outcomes and knowledge of patient care and treatment

Versatile communication skills

Line management experience

Demonstrated coaching and mentoring experience

Presentation and negotiation skills

Team and Cross-functional work demonstrating commitment, influencing, challenge and support

Fluent in verbal and written English

Strong analytical skill set

Demonstrated strategic agility Ability to anticipate and shape the future based on market, business, and industry trends

Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.