Phone: (267) 387-0090
Position Overview
Our client is a specialty pharmaceutical company committed to helping everyone they serve live their best life through the delivery of quality, life-enhancing therapies. Their decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, they boldly transform insights into treatments benefiting those who need them, when they need them.
The Clinical Development Director will be the clinical and medical strategic lead of one or more products/therapeutic area, accountable for all applicable pre-clinical and clinical projects. The Clinical Development Director will ensure the planning, implementation, managing, and reporting of the applicable pre-clinical and clinical studies in accordance to the product development plan.
The incumbent will build and strategize the product development (inclusive of target product profile, clinical development plan) for one or more products, and steer with the responsible team members within the department (clinical scientists, Associate Directors and medical monitors), cross-functional R&D, commercial/marketing, medical affairs/publication teams, and/or CRO(s), to strategize the preparation, review and execution of clinical study synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and TLF shells; guide the evaluation of emerging clinical trial data; oversee/guide the data interpretation and data mining; ensure that assigned studies are conducted according to GCPs and Departmental SOPs; oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data; oversee the review of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov (clinical trial registry and results database) and/or a TPR (Third Party Registry); and lead the preparation of NDA/BLA filing packages. Support VP, R&D Strategy on business development activities by evaluating new product potential.
The incumbent will have primary responsibility for providing product development status updates to the R&D Leadership Team. The incumbent will support Medical Affairs and R&D Operations teams with medical/clinical oversight and/or guidance on collaborative research programs applicable for one or products for which he/she is accountable.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority – span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Job Responsibilities
Product Development (20%)
- Lead and strategize the generation and implementation of product development plan (inclusive of target product profile, clinical development plan) for one or more productsSteer the R&D team members for the planning and execution of the pre-clinical and clinical programs in accordance to the product development plan (inclusive of target product profile, clinical development plan)
Clinical Trials Management (50%)
- Guide and organize the team members for the planning, implementation, managing, and reporting of clinical trials and programs in adults and children:
- Prepare, review, and approve clinical trial synopses and protocols, Investigator Brochures, and clinical study reports
- Review and approve Medical Monitoring Plan, Safety Plans, Protocol Deviation Plans
- Review SAPs and tables, LTF shells
- Oversee/Guide with data interpretation and data mining,
- Ensure that assigned studies are conducted according to GCPs and organizational SOPs
- Guide in conducting literature searches/reviews, meta-analyses, and publishing data
- Contribute to the preparation of IND/NDA medical sections
- Work closely with internal team and CRO in execution of trials, and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies
- Work with R&D Operations and/or Finance on the pre-clinical/clinical study budget and timelines
- Work/Guide R&D and Regulatory teams on clinical/medical responses to regulatory agency queries, meetings preparations and review of briefing packages
- Review/approve of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov and/or TPRs
Clinical Study Publication (15%)
- Lead the creation, review and approval of abstracts, posters and manuscripts for pre-clinical/clinical studies in support of the publication strategies for assigned brands
- Support Medical Affairs and R&D Operations team with medical monitoring and clinical oversight/guidance on collaborative research programs
Stakeholder Management (10%)
- Provide product development status to R&D Leadership Team
Business Development (5%)
- Function as the Clinical Lead for business development activities by evaluating new product potential
Job Requirements
- Experience in pharmaceutical research, specifically exposure to the IND/NDA/BLA approval process and preclinical, Phase I, II, III and IV clinical research.
- The incumbent should have at least 10+ years of directly related pharmaceutical clinical research experience.
- The incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information.
- Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are of the utmost importance
Knowledge
- Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- The position requires research administration experience, knowledge of scientific principles of controlled trials, and a comprehensive knowledge of FDA and ICH guidelines.
- This position also requires a working knowledge of software packages (e.g., MS Word, MS Excel, MS PowerPoint).
Skills & Abilities
- The abilities to work on a team, cooperate with colleagues, and effectively communicate with a diverse audience, at multiple levels, both inside and outside the company, are essential.
- A capability to work with cross-functional teams at the protocol and clinical program level is mandatory.
- Excellent human relations and communication (written and oral) skills are required.
- Effectively resolves conflicts between individual needs and requirements of the organization
- Demonstrates the ability to analyze complex situations and proactively identify opportunities/issues; effectively solves problems that cross functional boundaries
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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