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Puma Biotechnology, Inc. · 1 day ago

SVP Clinical Development - Remote Position

United States

Full-time

Remote

Lead/Staff, Director/Executive

$410K/yr - $440K/yr

5+ years exp

Puma Biotechnology, Inc. is a company focused on oncology drug development, and they are seeking a Senior Vice President of Clinical Development to lead their clinical programs. The role involves managing clinical development teams, defining clinical strategies, and ensuring compliance with regulatory standards while building relationships with external stakeholders.

BiotechnologyMedicalTherapeutics

Responsibilities

Managing, building, and leading clinical development teams to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH, and other global regulatory requirements

Playing a key role in defining “go/no-go” decision points, timelines and resources in alignment with the research and development goals and objectives of the collective as well as individual indications

Playing a critical role in defining and executing clinical development strategy in the context of financial and market environments, clearly articulating and developing opportunities and threats, and evaluating options and plans against anticipated commercial and scientific trends

Managing and maintaining strong, effective relationships with key external stakeholders and partners (i.e. KOLs and investigators, global vendors, consultants, patient advocacy groups, and other external clinical trial participants) to ensure that the primary goals of the clinical development programs are met

Leading medical monitoring activities including acting as primary point of contact for day-to-day medical guidance for clinical trial staff at study sites, as well as for regulatory, safety and clinical operations and other functions requiring clinical input

Providing clinical and medical guidance while working closely on joint projects with the medical affairs team to include IST studies, Scientific Congress/Conference strategy and planning, Advisory Boards, development of educational goals for medical education, publications, Field Force training, review of medical information standard response letters, health economics analyses, and marketing/policy related projects

Leading in the strategic clinical development plans and execute on same, including, for example managing or assisting with: + Scientific literature review and summarization + Protocol development + Regulatory briefing document preparation and review + Investigator meeting preparation and presentations + Clinical study report input + Assistance with writing and preparation of abstracts, presentations, and manuscripts

Working with the team to identify and evaluate scientific, business licensing, partnership, alliance and outsourcing opportunities

Working with key scientific and business executives in preparing presentations to the Board of Directors and Advisory Committees

Effectively communicating clinical information to both technical and non-technical audiences to enable them to create a compelling case for the company’s efforts with potential customers and the investment community

Qualification

Oncology drug developmentClinical trial planningClinical PracticeRegulatory guidelinesClinical development strategyTeam buildingRelationship managementScientific expertiseLeadershipCommunication skillsNegotiationProject management

Required

Must have a solid understanding of oncology and/or hematology drug development and life-cycle management

Full working knowledge of Good Clinical Practice guidelines

Demonstrated familiarity with PhRMA (the Pharmaceutical Research and Manufactures of America) code of conduct and with regulatory guidelines as they pertain to Phase IV activities

Experience in planning and execution of clinical trials and investigator sponsored trials

Ability to understand, interpret and explain scientific research and publications, presentations, and dissemination of clinical research data

Experience supervising technical and managerial staff over a wide range of accountabilities in development

Experience as a member of a senior management team responsible for achieving corporate goals

Excellent oral and written communication skills and interpersonal skills

Strong leadership, team building, negotiation, and ability to execute

Ability to manage multiple projects in a fast-paced environment

Ability to cultivate and maintain relationships throughout the organization and with thought leaders around the world and to establish trust through the consistent demonstration of scientific expertise

Willingness to travel within the US and internationally as required

5-10 years related international clinical development experience with a mix of corporate and academic experience required