Clinical Stage Biopharmaceutical company:
The successful candidate will be responsible for the execution of clinical development strategy, which includes study design, protocol development, execution, and regulatory interactions through all phases of clinical development. S/he will be critical to key decisions regarding resourcing and budgets, study designs and milestones, and regulatory interactions. S/he will also lead clinical discussions with regulatory agencies through registration and will also be responsible for ensuring compliance with departmental, company and regulatory standards and procedures as well as GCPs. This is a critical position to the business success of COMPANY with a responsibility for managing cross-functional teams of clinical development, non-clinical development, translational research and discovery scientists. S/he will be responsible for leading and managing a team that is responsible for the clinical development of all programs. The group includes other physicians and clinical scientists who are responsible for trials in phases I-III and related activities.
• Implements clinical research strategies and contributes to the development and execution of clinical research programs focusing on active programs and future programs moving into the development portfolio.
• Drives the authorship of clinical development plans that contribute to the product strategy plans; designs clinical trials and writes protocols and functionally lead the team that includes colleagues in Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Pharmacovigilance, Biostatistics and Programming, Medical Affairs, Non Clinical and CMC.
• Directs study design protocol development and implementation of clinical studies across all phases of development.
• Defines clinical study parameters, deliverables, and resource needs.
• Reviews and evaluates clinical research results to inform development strategy, operational tactics and future marketability.
• Performs medical monitoring/reporting and global safety assessment on company sponsored registration studies.
• Evaluates adverse events for overall assessment of benefit-risk.
• Prepares submission documents for new drug application to then regulatory agencies.
• Explores innovative translational research findings and concepts to assist in identifying new indications for development.
• Interfaces with key members of COMPANY’s drug discovery and translational medicine teams to contribute to success of portfolio.
• Acts as a liaison between COMPANY and clinical investigators.
• Develops credible and collaborative relationships with opinion leaders, medical directors, and key regulatory officials.
• Develops project-related budgets and monitors external spends.
• Ensures that all activities are in compliance with GCP’s and company SOPs.
Education & Requirements
• MD with hematology, oncology or rare disease training.
• A recognized development expert capable of establishing and maintaining external collaboration with companies, academic institutions and other institutions as appropriate.
• In-depth experience in and knowledge of drug development with a track record of success.
• Possess outstanding communication and leadership skills to maximize the effectiveness in a fast- paced high-growth science-focused R&D organization.
• Possess self-motivation, creativity and a willingness to take “roll-up the sleeves” approach to working and interacting with colleagues in a fast-paced, biotechnology environment.
Job Title: Senior Director, Clinical Development
Company is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines biological insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit.
About the Role:
• Develop and implement clinical development strategies/plans for novel drug candidates in oncology and non- oncology indications as part of a cross-functional project team.
• Work closely with project teams and the Translational Biology group to identify preferred therapeutic directions and patient selection strategies.
• Develop a deep understanding of the clinical and competitive environment and work with teams to develop target product profiles for projects in both research and development
• Serve as the medical lead for clinical protocols
• Partner with Clinical Operations on clinical trial conduct and monitoring, including GCP, patient eligibility, safety monitoring, AE and SAE tracking and reporting and protocol deviations
• Support timely and high-quality cleaning, analysis, interpretation and communication of data in ongoing and completed studies
• Co-author regulatory documentation and other communications, including filing INDs, IB, annual reports, CSR, abstracts, manuscripts and presentations
• Participate in regulatory authority interactions as necessary
• Develop productive relationships with external key opinion leaders and investigators and lead/participate in investigator meetings, advisory boards and site visits.
• Work and partner with internal and external (CRO, investigator) stakeholders
• Adhere to and implement quality standards and SOPs in clinical development
• MD or MD/PhD with at least 5 years of experience in Biotech drug development
o Board Certification/Board Eligible in medical oncology, hematology or immunology desired
o Experience with small molecule preferred
• Experience in Phase I-III protocol development and clinical strategy development is required
o Industry experience is required.
o Knowledge of the regulatory environment and experience with working with regulatory authorities is required
• Strong ability to integrate biological knowledge into clinical development strategy
• A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented and dynamic environment
• Excellent interpersonal skills and a demonstrated ability to work well within a matrix team structure is essential
• Strong written and verbal communication skills.
Ability to travel up to 20%