- The Vice President, Medical Affairs, will report to CMO. Will be a member of the senior leadership team in Oncology Clinical Development.
- Responsible for designing and executing registries, Phase IIIb/IV trials and other post-marketing requirements supported by clinical programs in the Oncology therapeutic area.
- Provide strategic and tactical post-marketing leadership for the Btk oncology molecule.
- Post-Marketing Leader for Btk oncology and other pipeline molecules planning development programs in oncology.
- Partner with the CMO to develop and implement the post-marketing plan for each of these molecule programs.
- Develop and implement the overall oncology (non-molecule focused) post-marketing plans.
- Provide cross-functional input in the development of strategic medical information plan when appropriate.
- Work with the CMO to define and develop credible relationships with national and international advisory boards, key opinion leader, co-operative groups, and advocacy programs as well as key regulatory offices. Should be perceived as a peer by clinical research leaders in Oncology as direct involvement in the interpretation and data display is anticipated.
- Provide deep and broad clinical expertise to cross-functional teams within the organization.
- Oversees the development of product life cycle strategies for Pharmacyclics products US.
- Ensures the safe and appropriate use of Pharmacyclics products through post-marketing commitments including medical/clinical education, training and communication.
- Well-designed and well-conducted formative/summative product testing investigational studies.
- Prompt and accurate responses to medical queries by medical professionals.
Education, Experience and Qualifications
- Medical Degree required with board certification or must be eligible for boards (Prefer Hematology/Oncology).
- The incumbent must be: a) skillful in identifying trends and anticipating issues that impact established strategies and initiatives and b) creative in identifying solutions that meet resource needs, regulatory requirements and public health needs.
- Experience leading change management where there was the need to influence, direct, or lead change to prepare the organization for the expansion, evolution and increased complexities associated with significant new corporate, business development and regulatory initiatives.
- Strong interpersonal, influencing, presentation, and communications. skills (written and verbal) to effectively address all levels within an organization.
- Proven ability to effectively work in a cross-functional/matrix environment most notable:
- Regulatory Affairs, Publication Planning and Medical Writing, Drug Safety, Corporate Communications .
- Research, Commercial, Product Portfolio Management/Program Management, Corporate Communications/Investor Relations
- A minimum of 10 years drug development experience in a credible large biotech or pharmaceutical organization/s.
- Clinical practice expertise in hematology and oncology preferred.
- Proven experience interacting with executive leadership.
- Proven experience interacting with the FDA, other regulatory authorities, and professional organizations regarding post marketing commitments, reimbursement/payor issues, expanded access programs, safety issues/initiatives, practice guidelines and medical education initiatives.
- Demonstrated achievement in the area of clinical development (successful NDA/sNDA submissions or publications supporting product differentiation claims) and product launches (IND, BLA, and NDA).
- Solid understanding of product/clinical development and medical affairs.
Pharmacyclics, Inc. - 2 years ago