Reporting to the Vice President, Clinical Development, the Medical Director will lead clinical development strategy and clinical operations for active programs. Duties will include management of cross-functional, multidisciplinary study teams, and oversight for the design and execution of clinical trials. S/he will serve as the Medical Lead and primary Medical Monitor for clinical trials. The Medical Director will work closely with all matrixes of the team including scientists in discovery research, clinical operations, and regulatory affairs. The Medical Director will also participate in advisory meetings with opinion leaders and academic study investigators and will support interactions with Health Authorities.
Essential Functions
- Lead the development of study protocols, statistical analysis plans, investigators brochures, and other key study documents in conjunction with Perspective Leadership and key advisors.
- Prepare the clinical development plans with support from cross functional team members.
- Perform regular data reviews (including e.g. PK, safety, efficacy).
- Provide leadership on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution and data analysis.
- Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate, and interface with regulatory authorities as needed.
- Communicate with and inspire key external stakeholders to facilitate the development and medical oversight of Perspective compounds. Stakeholders and mechanisms of outreach may include:
- Investigators, Medical Community (e.g., KOLs)
- Preparation and presentation of abstracts/oral presentations at conferences, and writing of manuscripts)
- Provide medical insight to Advisory Board meetings and develop learning materials for internal and external use.
- Present clinical data at relevant advisory board meetings and/or scientific meetings as needed.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience
- MD or equivalent, ABIM board certification/eligibility in oncology, nuclear medicine and/or radiation oncology is highly desired.
- Experience leading oncology early clinical development programs and working with discovery, preclinical, translational and external collaborators.
- A genuine interest and understanding of radiopharmaceuticals and the science supporting the pipeline, an ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and a commitment to developing new treatments for patients are critical for success.
- Hands-on pharmaceutical or biotech experience in oncology and/or radiopharmaceutical clinical development managing clinical trials and clinical development programs preferred.
- Experience leading clinical development teams and Phase 1 and 2 trials within the radiopharmaceutical space is highly preferred.
Knowledge / Skill / Ability
- Strong leadership, collaboration, and teamwork in a cross-functional setting; comfortable with a hands-on leadership position.
- Ability to prioritize and handle multiple tasks and to facilitate and resolve cross functional activities and issues required.
- Must be flexible, open minded and adaptable to the changing needs and duties associated with this role in a small company.
- Prior managerial experience including direct oversight of MDs, Clinical Scientists and MSLs as well as various functional groups such as but not limited to Statistics and Pharmacovigilance.
- Excellent verbal and written communication skills and collaborative interpersonal skills.
- Must be willing to travel up to 20% of the time, as measured on a calendar quarter. Both domestic and international travel may be required
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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