Reporting to the Senior Vice President of Clinical Development, the Executive Director of Clinical Development will provide strategic leadership within the assigned therapeutic area franchise (i.e. Cholestasis or NASH) and clinical leadership to a matrixed Clinical Project team to ensure successful design and implementation of Clinical Development Plans for that therapeutic area. Major areas of responsibility include strategic leadership in the Cholestasis therapeutic area, design and ownership of the cholestasis clinical development plans, KOL liaison and management, clinical trial design, clinical data analysis, internal and external communication of project information and plans, and strategic/expert contributions to regulatory submissions, publications and presentations.
This position is specifically responsible for developing and leading the cholestasis clinical strategy in alignment with the business and R&D strategies. This role will generally be the key point of contact for all clinically-related activities in the cholestasis therapeutic area.
- To perform this job successfully an individual must be able to perform each essential function satisfactorily:
- Lead critical, clinically-focused strategic decision-making in the Cholestasis franchise.
- Translate concepts/strategies into specific objectives and activities to effectively achieve goals by leveraging and motivating cross-functional stakeholders.
- Interact internally and externally with executive level management requiring negotiation to influence decision-making bodies and to facilitate clinical trial research.
- Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.
- Identify and evaluate complex clinical problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.
- Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents, ensuring documents are are in alignment with R&D strategy.
- Provide scientific and medical expertise and support to externally facing groups, including the field medical team, medical information, research and development strategy team, and the commercial organization.
- Contribute to departmental resource planning, budgeting, and timeline setting to meet company needs.
- Demonstrated capability to provide direct oversight and coaching to research scientists and physicians.
Clinical Development Activities
- Develop and keep current the Clinical Development Plans for the cholestasis therapeutic area.
- Lead the development and maintenance of cholestasis clinical development plans.
- Lead action-oriented, cross-functional clinical project team meetings and periodic project reviews; Team to ensure the optimal planning, implementation and interpretation of clinical studies.
- Contribute to the strategic planning, authoring, and review of regulatory documents providing direct leadership/oversight to clinical sections of these documents; Serve as primary clinical representative in support of regulatory interactions.
- Provide scientific/medical oversight to scientific data disclosures including publications and commercial support documents, ensuring strategic intent is aligned with corporate and R&D strategy.
- Provide scientific/medical expertise and support to externally facing groups, including the field medical team, medical information, and the commercial organization.
- Build productive relationships with investigators, key opinion leaders, and key stakeholders in the medical/scientific community.
- Lead development of specific scientific and/or clinical topics of interest such as those for discussion at advisory boards (Clinical advisory boards, Medical advisory boards, etc).
- Interact with external medical/scientific advisors, thought leaders, clinical investigators in the therapeutic area, internal leadership, and drug development staff to prepare/revise/maintain and efficiently execute the development plans
- Manage and partner with internal and external clinical experts to support data generation necessary for regulatory filings and publications.
- Represent project(s) to corporate partners, investors and clinical investigators as required.
- Maintain clinical and technical expertise in the therapeutic area; consistent review of scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams.
- Assist in accomplishing department and corporate objectives as it relates to the cholestasis clinical plan.
Experience and Skills
- Pharm D., M.D. or Ph.D. in a related field preferred with 8 years or more direct biotechnology or pharmaceutical industry experience in Clinical Research. Prior experience in Hepatology, Gastrointestinal or related field, preferred.
- Excellent knowledge of the drug development process.
- Proven leadership abilities in a highly complex and fast-paced environment where negotiation skills are essential for success. Must be able to work on multiple complex projects simultaneously.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Strong communication skills, including writing and presentation skills, with success in influencing at all levels cross-functionally.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies.
- Strong familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Highly proficient in standard computer software (Word, Excel and Power Point).
- Ability to travel, in some cases, internationally. Average travel expectations: 10- 20%/year.
- Job Tracking ID : 85486-280624