The Medical Director (“MD”) will have responsibility for defining and executing clinical studies to advance early development opportunities from pre-IND through pivotal trials. This individual will provide medical expertise during the design, execution, and reporting of clinical studies; be the primary medical representative for BVD for medical monitoring and patient safety of studies conducted; participate as a member of project teams and relevant cross-functional sub-teams to ensure tactical alignment and execution; and work with external contract research organizations (CROs).
Organizationally, the MD will report to the Chief Operating Officer, Dr. Brent Kreider, with significant interaction with the President & CEO of BVD, Dr. David Chao. The successful candidate will be a strong multitasker, capable of assuming several different roles/responsibilities and coordinating dozens of medical and regulatory collaborators within BVD’s CRO and CMO partner network.
General responsibilities for the position include:
Applying subject matter expertise in the formulation of clinical development plans, including selection of the Proof of Concept indication. Designing and authoring study protocols and interpreting clinical study data.
Ensuring seamless integration of strategy and execution by working in partnership with clinical operations colleagues, including selection of investigators/sites, KOLs and CROs.
Serving as the BVD point of accountability to the study medical team, along with the Medical Monitor and Principal Investigators.
Reviewing all study safety data and implementing responses, as appropriate.
Effectively communicating project strategy, data, and future plans with both internal and external stakeholders across all organizational levels, including with Regulatory, KOLs, consultants, project team, and BVD leadership.
Authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
Providing ongoing scientific and medical leadership to team members regarding disease area and therapeutic agent(s).
Effectively collaborating with all elements of project teams, including statistics, PK/PD, Regulatory, Clinical Operations, Biomarkers, Translational Medicine, Project Team Leadership, and Management.
Conducting studies on-time and within established budgets.
Functioning as the main clinical representative for in-licensing activities, including due diligence reviews.
The immediate, short-term objectives for this position will be to: (1) embark upon a listening tour within the organization, with an objective to quickly establish relationships with current team, (2) deeply immerse into the current Ulixertinib Phase II efforts which will represent immediate need and major focus of the position, and (3) successfully gain additional exposure to the Phase I efforts concerning the CNV-NT program and clinical planning for 2021.
A doctor of medicine degree with a minimum of four years of demonstrated knowledge and experience in clinical research related to responsibilities of the job.
Oncology training or experience required.
Knowledge and experience using related disciplines (e.g. biostatistics, regulatory, pre-clinical and translational pharmacology, pharmaceutical sciences).
Significant knowledge and experience in developing Phase I & II protocols; analyzing safety and efficacy data as well as pharmacokinetics and pharmacodynamics.
Leadership skills in working successfully with teams to advance both small molecule and biologic pharmaceuticals through preclinical and clinical stages.
A record of demonstrated productivity as evidenced by authorship of relevant sections of regulatory submissions for INDs and CTAs and an established track record of publishing articles and abstracts in professional journals.
Proven scientific writing skills and the ability to communicate effectively both verbally and in writing with superiors, colleagues, and individuals inside and outside the organization.
Preference will be given to individuals with industrial critical path thinking skills.
A track record in creating and utilizing sophisticated database techniques to integrate analyses with scientific and business objectives.
Telecommuting is allowed.
Additional Salary Information: BVD offers a competitive compensation package consisting of a base salary and a vast array of employee benefits. The benefits package consists of medical, dental, vision, life, and disability insurance, 401k match and a separate profit sharing plan. Reasonable and common relocation expenses will be tailored to the organization’s and the successful candidate’s mutual needs and objectives.
Internal Number: 3119
About BioMed Valley Discoveries
EFL Associates is a retained executive search firm that provides executive recruitment solutions for clients who need to select the best talent possible to lead their organizations' key roles. With offices in Denver, Kansas City and St. Louis, EFL Associates brings deep knowledge and a 40-year history of providing talent management solutions. As a small firm backed by national resources, we are able to be flexible in serving you, while at the same time ensuring you get top-quality talent that fits your organizational goals.
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