Summary of Position
The Clinical Research Director/Sr. Clinical Research Director provides medical input to all aspects of product development, for new and innovative treatments being developed in patients. Will serve as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory Lead, and the operational lead(s) for overall programs within the therapeutic area. Develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists. Acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.
Responsibilities and Job Duties
- Collaborates with colleagues in clinical development and operations, research, bioPharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
- Ensures that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company’s sponsored clinical trials.
- Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration and provides clinical and medical perspective to preclinical development programs.
- Responsible for medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications under the direction of the clinical leader or delegate.
- Directly develops or guides development of scientific/medical portions of clinical study reports, safety reports, and regulatory submissions to assure production of high quality documents.
- Directs protocol implementation, including site identification and communication, attend investigators’ meetings, correspond with sites including IRBs, and interact with operations teams.
- Supports data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts.
- Organizes clinical advisory boards, steering committees and data safety monitoring boards as required.
- Acts as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
- Ensures the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and applicable local practices.
- Responsible for establishing and maintaining communications with prominent clinical investigators in his/her particular field of expertise.
- Works with international colleagues and with external Alliance partners on research initiatives and regulatory issues.
- Serving as an information resource to the Company with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
- Oversees and provides leadership to colleagues involved in clinical trial execution.
- Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
Education & Credentials
M.D., with subspecialty board eligibility/certification in oncology
Clinical Research Director
- Minimum of 3 years of successful clinical research and/or drug development experience in biologics
- Experience in immuno-oncology clinical research
- Prior clinical development experience for/in the pharmaceutical/biotechnology industry or academic medical setting.
- Possesses early phase clinical development experience
Sr. Clinical Research Director
- Minimum of 5 years of successful clinical research and/or drug development experience in biologics
- Several years of experience working in the field of oncology
- Possesses a mix of both early and late phase clinical development experience
- Two years of clinical development experience for/in the pharmaceutical/biotechnology industry setting.
Knowledge, Skills and Abilities
- Ability to collaborate effectively with many functional areas and a positive track record of working within the team setting
- Understanding of the unique product safety, clinical development and regulatory requirements of biological products
- Well-regarded for intellectual strength and achievement as a clinical scientist
- Effective influence and relationship management skills with internal and external partners
- Demonstrate the ability to think creatively and strategically
- Strong analytical and problem solving skills
- Excellent written and oral communication skills demonstrating ability to organize, interpret and communicate complex information effectively and succinctly including formal and informal presentations
- Strong understanding of principles of GCP, ICH and CFR
- Working understanding of statistical principles and guidelines as these apply to clinical trials
None at this time