Our 25 employee immuno-oncology biopharmaceutical partner is a clinical-stage company committed to advancing antibodies with best-in-class potential. Their leadership team has successfully developed new drugs before. They know what they need to do, and are committed to excellence in all that they do backed by a number of leading investors.
This group of cancer battling soldiers lead a privately-held, clinical-stage immuno-oncology company focused on the discovery and development of best-in-class antibody therapies.
Their mission is to discover, develop and deliver innovative therapies that improve the lives of those affected by cancer. They can accomplish that goal through the collective efforts of talented individuals, such as yourself, who work together to advance scientific research. If your drive is to impact and literally shift cancer treatment…well, this is the role for you.
As the Medical Director you will work directly with the CMO and contribute both strategically and tactically. You will roll up your shirt sleeves and provide expertise to multiple studies currently focused on multiple myeloma and other indications (to be determined).
Our partner places a premium on integrity, respect, and collaboration. Most importantly, they recognize their responsibility to people with cancer who need new treatment options. With recent funding and reliable investors there is plenty of run-ramp for this focused and determined growing biotech.
Let’s bottom line this…your ability to work with others, your attitude of being humble…yet hungry, is the key to success. Your internal drive and eagerness to learn is what will propel you with this innovative and “outside the norm” biotech.
Strategic Leadership Objectives:
-Lead study teams in writing synopses and background sections of the protocols, review and approve study processes, ICFs, and deliverables.
-Participate in development of regulatory and study documents, CRFs, statistical analysis plans (SAPs), SRC charters and other documents as required.
-Finalize protocols and amendments.
-Design protocols and clinical studies to meet the agreed strategic contexts.
-Interact with regulatory agencies and internal auditing groups on a study level, providing a response and updates to inspection observations.
-Assists with regulatory activities to support study conduct and future marketing approval strategy and execution.
-Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
-Ability to think strategically, innovatively, and tactically.
-Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
-Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
-Presentation skills, got to have them.
-High integrity, “get-it-done”, “roll-up-your-sleeves” attitude and committed to putting patients first.
Clinical Development Objectives:
-Provide Study team with medical expertise during key activities.
-Oversee and conduct protocol training; produce relevant materials.
-Develop and deliver protocol training during Investigator meetings and Site Initiation Visits (SIVs).
-Create medical training materials for SIVs, and the study team.
-Produce Clinical Study Reports (CSR), approving patient narratives.
-Contribute to IB updates for the project.
-Assist in development of scientific meeting abstracts and presentations as well as manuscripts, including slides for Board of Director/Advisory Board Meetings.
-Responsible for study conduct in conjunction with clinical operations.
-Actively interact with investigative sites, Site Department Review, IRB, etc. by responding to protocol/medical/safety questions, reviewing the literature as needed.
-Participate in Clinical Sub Team, Development Team and Project Team meetings, as required
-Assist with subject evaluation and protocol adherence.
-Review and approve enrollment packets.
-Review safety reports to support regulatory notifications and filings
-Participate in vendor selection for CRO and other outsourcing vendors.
-Study Level Data Review.
-Review all patients narratives and patient data generated by data listings or statistical analyses.
-Review individual data with SAEs and potentially clinically important laboratory tests or vital sign abnormalities.
-Review protocol deviation reports and participate in all reviews and procedures required for database lock.
-Request additional tables or analyses where appropriate.
-Participate in safety evaluation and support for the investigational products.
-Answer medical/safety protocol questions and resolve issues from sited. CRAs and study team, ensuring answers are consistent across all sites and studies.
-Review study and individual subject safety for assigned studies and present findings.
-Perform other duties as required.
-MD with experience in oncology clinical trials and drug development.
-Ability to work in a fast-paced, biotech environment.
-Demonstrated experience conducting clinical studies supporting early stage cancer research.
-Experience interacting with Translational Medicine.
-Experience interacting with FDA, other regulatory agencies
-Flexible to accommodate changes in team and project needs.
-Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
-Excellent interpersonal, verbal, and written communication skills.
-Ability to make independent, timely and appropriate decisions.
-Good written and oral communications skills.
-Ability to develop/maintain an effective professional network and develop partnerships and strategic collaborations.
-Strong planning and organizational skills.
-Good problem-solving skills and ability to exercise sound business judgment.
-Initiative and execution orientated with evidence of tenacity and perseverance.
-Strong ethics with good attention to detail and commitment to excellence.
-Located in the San Francisco Bay
-They know their employees are the most valuable asset, and their culture conveys that!
-Our partner offers a generous benefits package including medical, dental, vision, and disability insurance, as well as paid time off and a 401k plan.
Corporate Facts & Objectives:
-Our partner prides itself on a dynamic culture which remains true to its values while embracing continued growth and change. Their work is marked by innovation, integrity, rigor, transparent communication, and collaboration.
-This is a team of highly experienced and driven professionals who are committed to excellence in all that they do.
-Supporting patients and advancing science form the foundation of our culture. To meet their ambitious goals, they foster a diverse and collaborative environment that values each of their employees and their unique contributions.
-25+ employees with continued projected growth over 2020.
Shawn Friend I 508.469.1112 I email@example.com