Executive Medical Director- Nephrology
$320kVertex Pharmaceuticals LLC
Job Description General Summary The Executive Medical Director, Clinical Development will provide high-level input on clinical development strategies to povetacicept renal programs, in conjunction with other relevant functional area leaders in Medical Affairs, Regulatory, Global Patient Safety, Clinical Operations, Exploratory Development, Commercial, Pharmaceutical Development, Research, Business Development, and Marketing. Initiate and lead innovative approaches to clinical development. Key Duties and Responsibilities Broad and comprehensive understanding of the drug development process Well-respected authority in the external clinical development community Provide clinical development recommendations to project teams, including optimizing study design and conduct for efficiency and effectiveness. Participate in planning for worldwide clinical development activities Provide guidance to multi-disciplinary development teams Review study protocols Review Investigator Brochures Review and evaluate study subject exemptions Oversee medical monitoring of clinical studies Evaluate adverse events and overall safety profile Participate in data reviews Interface with international regulatory authorities, as appropriate, in support of the development objectives for the compound or program Ensure compliance with Vertex Standard Operating Procedures, International Conference on Harmonization, Good Clinical Practice, and other national and international regulatory requirements As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff. Knowledge and Skills Global clinical research experience and experience interacting with regulatory authorities is highly desired Possesses a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process Possesses a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes Experience in filing and defending US INDs and/or NDAs and/or their international equivalents Enterprise-wide thinking and ability to work in ambiguity, including being hands on in order to ensure the work that needs to be done by the team gets done; other duties as required or assigned Ability to work and lead collaboratively in a challenging fast-paced, team-based matrix environment Ability to work independently to resolve challenges and conflicts Excellent oral and written communication Excellent leadership skills Board certification/eligibility in a medical specialty desired. Education and Experience MD, DO or equivalent ex-US medical degree 15 years pharmaceutical industry experience, including time managing clinical trials and/or clinical development program(s), or the equivalent combination of education and experience 7 years of management experience #LI-JM1 Pay Range and Disclosure Statement Pay Range: $320,000 - $480,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as:
- Hybrid: work remotely up to two days per week; or select
- On-Site: work five days per week on-site with ad hoc flexibility.
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