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location: Telecommute
job type: Contract
salary: $215.15 - 253.11 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
The company's West Coast Hub is seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs, with a specific emphasis on immunological complications of transplantation. Reporting directly to the Clinical Development Lead the MD and as a key member of the clinical development team, you will support the development of our novel therapeutic candidates in late-stage studies. You will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.
As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.
- Support the design and execution of clinical development plans for the company's programs within the transplantation therapeutic area, ensuring alignment with strategic objectives and timelines
- Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
- Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
- Draft and coordinate completion of clinical study reports
- Prepare responses to questions from Ethics Committees and Health Authorities
- Support integrated document development for marketing authorization filing
- Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
- Support preparation for FDA Advisory Committee and EU Oral Explanation
- Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
- Establish and maintain relationships with key opinion leaders and clinical investigators in the transplantation field and disease areas related to clinical development programs
- Ensure compliance with regulatory requirements and guidelines
- Collaborate with cross-functional teams
- Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
- Present relevant clinical data to internal stakeholders
- Represent the company externally at scientific conferences, investor meetings, and other industry events
qualifications:
You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients.
- MD or equivalent degree, with board certification in nephrology, immunology, or similar field.
- Minimum of 3+ years of clinical development experience in the pharmaceutical or biotechnology industry, with a track record of successful drug development.
- Experience in late-stage drug development, with a preference for experience in transplant, nephrology and/or immuno-inflammatory indications
- Strong knowledge of clinical trial design and execution, including experience with adaptive trial designs and biomarker-based approaches
- Deep understanding of regulatory requirements for drug development, including experience leading interactions with global regulatory agencies
- Strong interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach
skills: Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
