This is a biopharmaceutical company that focuses on therapies for cancer patients.
Position Title: Executive Director, Clinical Development — JO#2103-5566
Therapeutic Area: Oncology
The Executive Director Clinical Development leads the clinical development of the Company’s products. This role reports to the Chief Medical Officer.
Essential Duties and Responsibilities
- Provides medical leadership and strategic direction to the clinical development team.
- Works closely with the CMO and various functional leaders to develop and update Clinical Development Plans for each product/asset.
- Provides medical/clinical input into the creation of protocols and all other study-related documents.
- Provides input into SOP gap assessments and assists with SOP creation and revision as requested.
- Provides medical support to investigative sites and project staff for protocol-related issues, including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Participates in medical/safety discussions with Principal Investigators (PIs), study team members regulators, and key opinion leaders.
- Provides oversight to the medical monitor(s) and study teams.
- Attends CRO/vendor kick-off meetings, weekly team meetings, and vendor meetings.
- Provides consultation for medically-related questions from participating vendors, affiliates, etc.
- Participates in the development of Medical Monitoring Plans.
- Engages cross-functional internal workstreams, including drug safety and pharmacovigilance, biostatistics, data management, clinical operations, and Regulatory Affairs.
- Participates in the scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed.
- Works closely with Regulatory Affairs, Safety and PV, and other cross-functional team members to ensure oversight of critical safety issues and benefit-risk assessments.
- Key member on the Safety Oversight Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies.
- Provides medical content and reviews of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports.
- Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator safety communications, product labeling/package inserts, and other safety-related reports as necessary.
- Participates in the clinical safety and benefit-risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees.
Qualifications (Education & Experience)
- MD or DO from an accredited institution of Medical Education (Fellowship-trained Oncologist, Board-Certified in Oncology preferred).
- Active or inactive US license to practice medicine or international equivalent.
- Minimum of 15 years applicable experience (clinical plus industry).
- Completion of a US residency or ex-US equivalent and Oncology Fellowship training with at least 2 years of clinical experience beyond completion of Fellowship
- Minimum of 10 years of experience in Clinical Development in the biopharmaceutical industry.
- Excellent scientific/clinical and analytical knowledge base, with the ability to assess data and understand the safety/medical implications.
- Strong ability to understand and evaluate technical, scientific, and medical information; exposure to clinical data collection, assessment, and analysis.
- Computer skills should include proficiency with Microsoft Office.
- Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented.
- Working knowledge of global drug development and pharmacovigilance guidelines and regulations.
- Detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines.
- Excellent teamwork and collaboration.
- Proficiency in verbal and written communication. Excellent English written and verbal communication skills.
- Commitment to the highest standards of patient management, GxP, and clinical research.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs and Clinical Operations professionals in life sciences companies in the United States and around the world.
TriNet Pharma has identified and placed Medical Science Liaisons, Clinical Trial Liaisons, and director-level and executive-level professionals across multiple therapeutic areas. The company has a performance-based culture built upon trust, leadership, expertise, and accountability, which have allowed it to enjoy year-over-year growth.
Learn more at www.trinetpharma.com.