SVP, Clinical Development

Role Overview & Key Functions:

The SVP of Clinical Development will be a key member of the CMO leadership team and will be responsible for asset and indication strategy, clinical trial strategy, execution, and analysis of all data.  Along with this, the SVP of Clinical Development will support and build the clinical development team which includes medical leads, medical directors, and clinical research scientists who will be responsible for designing and monitoring assigned trials. This individual will work across the organization working with the PV, Regulatory, QA, Commercial, Medical Affairs, Business Development, Data management and Clinical Operations.

Reporting to our Chief Medical Officer you will positively impact patients’ when you:

RESPONSIBILITIES:

• Provide strategic input to portfolio management and prioritization

• Serve as the key partner and contributor for the strategic planning, support early and translational development; and prepare specific strategic plans and initiatives.
• Closely collaborate with the Medical Director and Scientists in the development of new strategic options for assets in late development.
• Participates in the development of Study Protocols, Investigator's Brochures, DSURs, publications, presentations and other key documents in conjunction with other line functions and with minimal guidance.
• Participates in cross-functional teams, as needed, for assigned trials, working with other team members to achieve efficient, high-quality study execution.
• Reviews and may participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
• Chairs the Document Review Committee
• Acts as liaison between Clinical Development and other internal groups at Karyopharm (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
• Develop and execute life-cycle management plan, lead data generation activities such as medical affairs studies to unmet medical needs and data gaps
• Support Medical Affairs: Working with field medical, Scientific Communication and Publication, Medical Information and Communication teams and provide support including reactive material development to address external stakeholder questions
• Help identify and effectively interact with thought leaders to engage in scientific and medical exchange as well as understand unmet medical needs and data gaps
• Support IST Program
• Partner with pharmacovigilance to assess the safety profile of compounds
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholder.
• Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards
• May participate in or lead clinical development contributions to due diligence or other business development activity
• Supports clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
• Present at scientific, medical and regulatory meetings globally
• Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
• Contribute to activities in support of the company’s planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents

Candidate Profile & Requirements:

• MD, DO or equivalent ex-US medical degree.
• Minimum of 15 years clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies;
• Experience leading a Clinical Development function
•  Significant experience managing a team
• Ability to work across multiple clinical programs and disease states
• Hands-on experience working with the FDA and other regulatory agencies on registrational studies, and post-approval activities
• Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s)
• Excellent oral and written communication skills
• Ability to work