Job Description
Job Summary:
Precision is seeking an experienced and passionate regulatory physician to join our team as Vice President, Clinical Development. The Vice President, Clinical Development will have a demonstrated background in Autoimmune or Oncology depending on the needs of the business. The ideal candidate will have a deep understanding of the US Food and Drug Administration framework, and innovative regulatory strategies to accelerate drug development.
The Vice President, Clinical Development will be responsible for driving product development across the Precision portfolio, including drugs, biologics, and cell and gene therapies for autoimmune and/or oncology/rare conditions. The role will focus on regulatory strategy and clinical development, for early to late phase trials.
Main Duties and Responsibilities:
- Reports to Chief Medical Officer, and across Precision for Medicine, supporting medical strategy.
- Provides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetings.
- Provides strategic drug development consulting to autoimmune, or oncology depending on specialty, and rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insights.
- Create, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications.
- Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed.
- Participate and drive feasibility discussions relating to specific project proposals.
- Develop training modules and conducts training for project teams and colleagues as necessary.
- Ensure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct.
- Propose strategies to manage and accelerate timelines for drug development strategies.
- Ensures customer satisfaction by working closely with senior management, PFM operations, to provide optimum strategic consultancy to clients.
Education and Experience:
Minimum Education and Experience:
- Successful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Endocrinology, Rheumatology, Hematology-Oncology or other related field, board certification preferred, including European equivalents).
- Experience in direct interactions with US and/or EU Regulatory Authorities
- At least 10 years of senior leadership experience in the clinical research industry with a demonstrated knowledge and substantial experience including related disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, etc.) Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
Knowledge, Skills, and Competencies:
- Clinical experience with previous exposure to regulatory and statistical activities such as (co) authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND, NDA, PSUR, DSUR, IB, ICF, Breakthrough Designation, and regulatory briefing documents
- Working knowledge of the safety reporting process globally
- The ability to travel domestically and/or internationally for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
#LI-Remote
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$254,900—$382,300 USD
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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