Vice President/ Senior Vice President, Pulmonary and Rare Diseases Clinical Development
SUMMARYThe Head, Pulmonary and Rare Diseases Clinical Development reports to the Chief Medical Officer, Therapeutics. This is a high-profile role, and the successful candidate will provide strategic leadership within the therapeutic area franchise and clinical leadership to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. Major areas of responsibility include strategic leadership in the assigned therapeutic area(s), design and ownership of the clinical development plan, KOL liaison and management, clinical trial design, medical monitoring of Arcturus-sponsored clinical trials, clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications, and presentations.RESPONSIBILITIES
- Make critical strategic decisions
- Develop and keep the clinical development plan current
- Design of clinical trials and writing/review of protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
- Lead action-oriented project team meetings and periodic project reviews, including setting appropriate agendas and approving actionable minutes
- Identify emerging risks and manage them with the Project Manager and other team members (as appropriate)
- Act as Medical Monitor for Arcturus-sponsored clinical trials
- Interact with external medical/scientific advisors, thought leaders, and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan
- Maintain medical/scientific standards, educate team members, and manage the Scientific Advisory Board (SAB)
- Involvement in management (and other oversight) committee meetings, including Research Management Committee (RMC) and Management Team
- Interact with regulatory agencies in concert with the Regulatory Affairs Department
- Represent project(s) to corporate partners, investors, and clinical investigators – as required
- Develop and oversee the project budget with the Project Manager and Finance Department
- Develop external advocates for the company’s technology, products, and direction
- Facilitate the effective conduct of clinical trials by:
- Developing and maintaining excellent working relationships with investigators
- Ensuring that all GCP requirements are consistently met
- Delivering high quality scientific presentations on company technology, investigational agents, and/or clinical study issues to investigators and clinical site staff
- Providing guidance and/or training for external personnel/parties involved in Arcturus’ clinical studies
- Performing clinical study data review and analyses
- Mentor Arcturus team members, as required
- Facilitate, assist and/or participate in the preparation of clinical study manuscripts by investigators, internal personnel, and/or contract writers
- Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings, and partner with company medical, research, and commercial teams
- Assist in accomplishing department and corporate objectives
- Other duties as assigned
REQUIREMENTS
- Advanced medical degree (MD or DO preferred)
- Board certification (or equivalent) in respiratory medicine strongly preferred
- 7+ years’ clinical research experience obtained in the pharmaceutical industry and excellent knowledge of the drug development process
- Comprehensive and detailed experience of clinical trial design, implementation, and sponsor/site interactions in conduct of clinical trials
- Must have experience working in a leadership role within the development project team, e.g. member of a core project team, sub-team leader, etc.
- Proven proficiencies with a wide range of data/information: e.g. scientific/clinical, legal/regulatory, business, financial
- Strong communication skills (including writing and presentation skills) with success in influencing at all levels cross functionally
- Proven track record of interacting with regulatory agencies in North America and Europe; experience with regulators in SE Asia is an advantage[DG1]
- Proven leadership abilities in a highly complex and fast-paced environment where negotiation skills were essential for success
- Excellent business acumen and demonstrated ability to align teams to the corporate strategy and drive to achieve business and project objectives
- Experience working with corporate partners is an advantage
For a deeper dive into our company and corporate culture visit www.ArcturusRx.comArcturus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
300000.00 To 350000.00 (USD) Annually
