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.
- Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses. A “solutions provider” who practices the “art of the possible” as opposed to the “art of the how.”
- High level of openness with a commitment to transparent reporting and analysis.
- Enthusiastic and forward thinking, progressive and participative, combined with the poise and maturity appropriate for an executive in such a position.
- A personal values system that encompasses high integrity, commitment to quality, a sense of mission, and similar qualities of the highest caliber in order to effectively match up with the culture and fiduciary nature of the Institute.
- Excellent interpersonal skills, able to establish and develop instant credibility and respect, display an empathetic personality and able to identify positively with people at all levels of the organization within a diverse employee base.
- A team player who demonstrates and fosters a partnering attitude and capability to work with others in a positive and collaborative manner.
- Strong work ethic combined with natural self-starter tendencies, plus the agility to be flexible in style and approach.
- Quality strategic business judgment with the ability to quickly assimilate information.
- A strategic advisor and a practical “doer.”
- Solid business acumen with a results-first mindset; the ability to deliver outcomes rather than just output.
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