Global Clinical Development Lead
Proclinical is currently recruiting for a Global Clinical Development Lead of Oncology/Hemato-Oncology with a global pharmaceutical company located in Boston, MA. Successful candidate will be accountable for the clinical development of one or more products. This includes all aspects of product development from research to post marketing commitment.
- Define and maintain the Global Development Strategy for one or more assets and lead the project team up to and including life cycle management.
- Collaborate with Global Development Team Lead, Therapeutic Area Head, other R&D functions, Medical Affairs and Marketing teams to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provide scientific advice within R&D and other functions(e.g. Strategy Teams, Commercial Brand Teams) leveraging scientific expertise and providing guidance in support of brands and product launches.
- Lead and/or participate in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
- Co-Lead in safety review committees and risk management activities as appropriate.
- Assure conduction of appropriate steps to support Therapy Area and Commercial Teams in crafting target product profiles.
- Provide expert Medical advice/leadership to the project teams for the development of Phase I-IV clinical programs.
- Lead development of clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy.
- Participate in drug safety surveillance for Development projects.
- Provide credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Skills and Education:
- MD degree (required); specialty training in oncology and certification in hemato-oncology (preferred)
- With at least 5 years of experience in the Pharmaceutical Industry with relevant clinical development experience.
- Demonstrated ability to collaborate in a matrixed environment.
- Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities.
- Demonstrated in-depth understanding of drug development and pharmaceutical marketing within therapy area.
- Working knowledge of regulations relating to drug development and promotional activities.
- Demonstrated ability to communicate and plan effectively with other departments and to respond to inquiries or complaints from customers.
- Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences. Ability to act as company spokesperson or scientific witness as needed.
- Strong management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals' skills, talents and career interests which ensure development of a talent pool for the future. Ability to create and maintain and organizational structure that serves the needs of the business.
- Strong business acumen preferred with the ability to shape corporate strategy using knowledge of the global pharmaceutical industry· Ability to capitalize on business opportunities by developing well thought out strategies and initiatives.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call James Stevens at (+1) 646-693-0610 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.