Cascadian Therapeutics is a clinical-stage biopharmaceutical company specializing in developing innovative therapeutic product candidates for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is tucatinib (ONT-380), an orally active and selective small molecule HER2 inhibitor. We are headquartered in Seattle, Washington. For more information, visit www.cascadianrx.com.
The Vice President, Medical Affairs provides medical and strategic leadership the medical support activities for Cascadian Therapeutics' product candidates and commercial products. This key leadership role is responsible for all Medical Affairs functions, including Medical Communications & Education, Medical Information, and the medical field force (MSLs, CLS, Nurse Educators). This position is also responsible for Key Opinion Leader (KOL) development, supporting Investigator Initiated Trials, and providing medical support of clinical development products and new product approvals. As Cascadian Therapeutics evolves, this role will also provide medical information support to the future commercial organization.
Key Job Responsibilities:
- Provides strategic Medical Affairs leadership and direction for development stage and commercial products.
- Oversees the providing of clinical/scientific information to health care professionals (HCPs) and other customers consistent with FDA regulations.
- Creates and oversees the global medical outreach strategy.
- Identifies, develops and works closely with global key opinion leaders (KOLs). Develops and manages relationships with medical thought leaders and investigators; assembles and leads Steering Committee meetings and advisory boards, and participates in local/regional/national symposia as needed.
- Oversees the development of a conference, publication, and medical communication strategy, ensuring alignment with Research, Regulatory Affairs, Corporate Communications and corporate objectives.
- Participates in and represents Cascadian Therapeutics at medical conferences and other events as required.
- Develops and implements Continuing Medical Education (CME) activities.
- In collaboration with Corporate Communications, develops and implements patient advocacy strategy and activities.
- Provides medical/clinical/scientific information and expertise to internal Cascadian Therapeutics departments, including Commercial, Regulatory, Market Access, Corporate Communications, and Technical Operations/CMC.
- Serves as liaison with Commercial to ensure a smooth transition from development to commercialization of products and effective medical support for commercial products.
- Contributes medical expertise on an as needed basis to the Clinical Development group in review of such areas as clinical trial conduct and development plans.
- Identifies, assesses and recommends potential new pre-clinical and clinical research areas for marketed products and products in development.
- Identifies, recruits, retains, develops, mentors and evaluates Medical Affairs staff, including field-based staff.
- Participates in the preparation and support off regulatory documents, including the clinical section of INDs, CTAs, NDAs/BLAs, safety reports and annual reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Responsible for the integration of Medical Affairs objectives with those of Clinical Development and Commercial operations to ensure programs meet the needs of all constituents in a compliant manner.
- Contributes Medical Affairs expertise and leadership to development of corporate strategies to meet corporate goals and objectives, including risk mitigation and adjustment of plans as necessary.
- Evaluates, selects and negotiates with external Medical Affairs vendors/resources.
- Interacts with executive leadership, including proactively identifying potential issues, escalating issues as appropriate, and recommending and implementing solutions.
- Develops and manages budget to meet Medical Affairs goals.
- Leads the development of Medical Affairs infrastructure, policies, procedures, and records to ensure compliance with applicable regulations and standards.
- Performs other responsibilities as assigned.
Education / Experience / Professional Requirements:
- MD degree with board eligibility or certification in oncology or hematology preferred; or equivalent.
- Requires a minimum of 10 years of demonstrated clinical research experience in academic or industry setting.
- Medical Affairs leadership experience in the pharmaceutical/biotechnology industry experience is required; experience managing MSLs preferred.
- At least five years of management/supervisory experience is required.
- Knowledge of applicable U.S. and international regulations and guidelines, including FDA, EMEA/CHMP, GCP, HIPAA, Sunshine Act, FCPA, etc.
- Proven understanding of government and industry guidelines, regulations, laws, etc. for appropriate scientific/medical exchange and communication with HCPs and customers.
- Full understanding of all stages of pharmaceutical drug development process.
- Experience in analysis of research data and publications; strong working knowledge of biostatistics, GCP, scientific and clinical research methods and clinical study design, adverse event reporting and drug-safety surveillance.
- Proven experience in publication and manuscript preparation are essential.
- Strong leadership presence and excellent communication, presentation and negotiation skills, with the ability to influence decisions both internally and externally.
- Strong communication and presentation skills (one-on-one and in groups) at a professional medical level; persuasive, articulate and able to distill complex information into clear, concise concepts; straight-forward, direct and transparent communications and interpersonal approach.
- Effective at working in a highly collaborative environment, inspiring team members to contribute fully to meet team objectives.
- Proven leadership, coaching and mentoring skills.
- Ability to manage budgets, multiple projects, and timelines.
- Ability to collaborate cross-functionally across the company is required.
- Strong work ethic, unimpeachable ethics and honesty are critical.
- Requires overnight (including some international) travel as necessary (up to 30%), consistent with project needs.
Cascadian Therapeutics offers a comprehensive and highly competitive benefits package including medical, dental, vision care, life insurance, short and long term disability, stock options, ESPP, a matching traditional and ROTH 401(k) plan, and fully subsidized transit pass/parking.
If you are interested in working with our team in a collaborative and professional work environment, please Submit Resume ».
We are an Equal Opportunity Employer