Senior Medical Director, Rare Diseases
The Senior Medical Director will be responsible for providing clinical leadership in the definition of clinical development strategies, as well as the design, execution, and analysis of clinical studies conducted with company community, and industry partners. This position reports to the Vice President of Clinical Development.
- Lead project Team strategy, scope, complexity, size, budget, and deliverables, overseeing the development strategy, clinical development plan.
- Provide continual critical evaluation of the development strategy to maintain a plan that is competitive and consistent with current regulatory requirements, proactive identification of challenges, and development of appropriate contingency plans.
- Engage with scientific advisory board, key academic, community, and industry partners, and other thought leaders to innovate and refine clinical development strategies.
- Direct activities involved in interactions with regulatory authorities / agencies relevant to assigned compounds.
- Lead the design, data collection, review, execution of clinical studies in support of product development, ensuring rigorous and compliant study conduct with current health authority regulations.
- Assess clinical data and make clinical program recommendations regarding strategic direction, modification of study plans, go/no go decisions and changes in timelines.
- Provide leadership and serves as an advisor of the other clinical scientists and cross functional team members.
- Accountable to senior leadership for the timely and successful completion of program objectives
- Medical Doctor or non-US equivalent of a MD degree.
- Completion of a residency program strongly preferred with at least 8-10 years of experience in clinical development in the biotech or pharmaceutical industry.
- Excellent written and verbal communication skills. Phase I-III Clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to run a complex clinical research program independently.
- Proven leadership skills and ability to successful guide and influence a cross-functional team.
- Ability to interact externally and internally to support a global scientific and business strategy.
- Extensive knowledge of clinical trial strategy, design, execution, regulatory and compliance (GCP, ICH, etc.) requirements governing clinical trials.
- Must possess excellent oral and written English communication skills.
- Ability to exercise good scientific and clinical judgment to proactively identify and address complex problems.
- Clinical research and product development experience in the pharmaceutical or biotech industry
- Prior experience in regulatory submissions including IND/CTA’s, ODD, and NDA/MAA’s
- Prior experience in Rare diseases preferred
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary team
- Diplomacy and positive influencing abilities across cross functional teams