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We are seeking a physician-scientist to serve as a Senior Medical Director within Clinical Development. The incumbent will be primarily responsible for developing and executing an integrated clinical trial program including protocol design and medical oversight of new or ongoing studies. He/she will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 2 and 3 design and analyses, support regulatory interactions for product advancement, and work closely with operations to provide advice and decision making regarding medical input to achieve operational excellence. The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key SME for multiple in house functions. Medical insight across a myriad of functions from discovery to manufacturing are expected. Investigator engagement including travel to support face to face interaction and protocol training is a vital component of this role. Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast paced and intense environment. The Senior Medical Director will serve as a leader on one or more potentially pivotal programs reporting directly into the Head of Clinical Development.
Role And Responsibilities
Making vital contributions, and leading 1-2 pivotal programs in clinical development program
Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals.
Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies?
Presentations to various external stakeholders - regulators, governing and harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders
Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
Planning, reviewing and editing Clinical Study Reports
Planning, reviewing and editing publications from the program
Providing input on the design of clinical studies supporting clinical strategy
Other duties as assigned
Experience, Education And Specialized Knowledge And Skills
Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
5+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology
Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission.
Clear and provable evidence of effective leadership skills.
The pay range for this role is at the Senior Medical Director level is $320,000 - $342,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.
Seniority level
Executive
Employment type
Full-time
Job function
Strategy/Planning and Information Technology
Industries
Biotechnology Research
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