This job is currently Archived,
Posted on : 26 January 2017
- The Medical Director leads and drives strategy for the overall global clinical development in the assigned area, taking into consideration the medical, scientific, regulatory and commercial issues.
- Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions.
- This individual has the expertise for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned area in multiple regions.
- Applies clinical/medical decision making to clinical development issues.
- This individual influences TGRD and TPC senior leadership decision-making by setting strategic direction.
- Success or failure directly translates to the ability of VBD to meet its corporate goals and for company to have future commercial products.
- Clinical Development team participation and leadership
- Leads the Global Development Team managing both the US/EU Development Team and the Japan Development team for assigned compounds.
- In some cases may lead the US/EU Development Team but more likely will oversee the clinical scientist responsible for leading this team.
- Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.
- Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols.
- Recommends scope, complexity and size, which influence the budget of all aspects of a program.
- Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
- Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.
- A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Drives all Clinical Development activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies.
- Serves as an adviser to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives.
- For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Trial Medical Monitoring
- Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.
- Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance.
- External Interactions
- Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an adviser to the other clinical scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives
- Due Diligence, Business Development and Alliance Projects
- Responsible for evaluation of potential business development opportunities with regard to clinical development. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
- Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve company's strategic goals while striving to maintain good working relationship between our company and partner.
- Provides guidance to clinical scientists who are involved in some of these activities.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise and with the division to provide knowledge/understanding of market environment in line with status as the Vaccines Virus scientific content matter expert for assigned compounds.
- Represents clinical development on high impact/priority task forces across the organization or external to the company.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- MD or internationally recognized equivalent plus 5 years of clinical research experience.
- Vaccines experience strongly preferred.
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
- NDA/MAA/Submission experience preferred
- Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities across multinational business cultures
- Therapeutic area knowledge relevant to mechanisms of action of compounds in remit
- Regional/global Regulatory requirements
- Emerging research in designated therapeutic area
- Ability to drive to or fly to various meetings or client sites, including overnight trips.
- Some international travel may be required.
- Requires approximately 20% travel.
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