Sr Medical Director
321 Arsenal Street Bldg 312, Suite 301 Watertown, MA 02472 US
Planet Pharma's client is actively looking for a creative, resourceful, integrative thinker (Senior) Medical Director to lead one of our clinical development programs of a novel immuno-oncology therapeutic. The position will report to the SVP Clinical Development and will manage clinical scientist(s) and study physicians, as applicable, as well as provide clinical oversight of CRO staff, as applicable. The (Senior) Medical Director will translate science and strategy into executable, efficient clinical trials, be responsible for review of emerging clinical data and interpretation and reporting of study results. The candidate will be an independent, proactive, collaborative, experienced physician-scientist with experience working in oncology drug development.
- Set the clinical strategy, direction and goals for one project, including selection of indications and combinations to achieve proof-of-concept and pursue registration
- Articulate the Clinical Development Plan for the project in close collaboration with the Project Head and functional leaders for the project
- Serve as the Clinical Lead for the project and lead the Clinical Strategy project sub-team.
- Lead the clinical study protocol/amendment development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
- In collaboration with internal/external experts in biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contribute to the development of the plan to execute trial design including CRF design, laboratory manual review, data review plan, statistical analysis plan review and finalization.
- Lead the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting.
- Identify study issues and program issues by reviewing and monitoring emerging clinical data related to safety, efficacy and PK/PD. Identify risks and collaborate with the team to ensure risk mitigation.
- Provide medical monitoring for active studies or work closely with medical monitor(s) to ensure patient safety, study integrity and data quality.
- Maintain current knowledge of developments on the mechanism of action as well as treatment paradigms for relevant tumor types.
- Support the development of program documents, including the clinical sections of various regulatory documents such as IND, investigators’ brochures, clinical sections of regulatory submissions, annual reports and updates and clinical study reports to support product approvals.
- Work closely with the translational medicine team to support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules, and potential stratification biomarkers.
- Develop presentations to communicate study data results internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
- Participate in the cross-functional Development Leadership team.
- Medical Degree with post-graduate training and patient care experience in a relevant field
- 5-10+ years of oncology drug development experience within the pharmaceutical industry and/or at clinical sites. Experience with the development of immune-oncology therapeutics is preferred. Experience with both early stage and late stage development is preferred.
- Demonstrated ability to design, conduct, interpret and present oncology clinical trials. Experience understanding, interpreting and communicating clinical information including clinical data, literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
- Knowledge of the drug development process from pre-clinical steps through registration and post-registration required.
- Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
- Strong ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
- Strong organization, documentation and communication skills and a sense of urgency to move the program forward.
- Detailed knowledge of GCP, ICH Guidelines and current EU EMEA and US FDA regulations and a personal commitment to maintaining high quality and patient safety.
- Fluency in English, both written and oral
- Ability to travel up to ~20% of time.
- Resourceful, energetic, self-starter
- Approaches challenges with creativity and pragmatism
- Ability to engage team without direct authority
- Driven to move the clinical programs forward at full speed while maintaining quality
- A stimulating position within a high-potential innovative biotech company.
- The opportunity to work in a science-driven, dynamic, human?sized, respectful and professional environment.
- A challenging scientific and business growth environment where you are empowered to apply and develop your knowledge and skills as part of a talented and highly engaged global team.
- An attractive compensation and benefits package in line with the position responsibilities and your experience.
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