Director, Medical Affairs - Onsite

Overview

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Your Role:  (On-site 5 days a week) The Director, Medical Affairs is responsible for providing oversight to medical information and the Medical Science Liaison (MSL) field team.  In addition, this role will work with the departmental head to implement insight activity collation, tracking and follow throughs, clinical and investigator trial support as well as project planning. 

The Director of Medical Affairs leads and oversees the strategic direction of the Medical Affairs team, focusing on scientific exchange, thought leader engagement, and providing medical expertise across multiple functions (for example Sales Teams, Market Access and Reimbursement, Corporate Account Management, Nursing Services, Pharmacovigilance, Regulatory Affairs and Clinical Operations). This role is key in bridging the gap between clinical development, commercial functions, and external stakeholders, ensuring the communication of accurate and impactful scientific data.  The role is office-based, requiring moderate travel, and all-encompassing support and essential functions are to be conducted within appropriate, compliant, and safe-harbor requirements.

Responsibilities

Your Work:

• Develops annual field medical affairs strategy, objectives, action plans and budgets that align with company-wide and department objectives.
• Works with clinical operations and the field medical team to identify investigators and study coordinators to support site identification, site initiation, protocol education, and patient enrollment in Dendreon sponsored clinical trials.
• Independently executes medical strategies to ensure clinical information exchange and scientific and medical information dissemination to health care professionals that supports current department and company business objectives.
• Plan and implement regional and national meetings of the medical organization including coordination of congress activities.
• Participates in and represents Dendreon Medical Affairs at medical congresses.
• Manages investigator communications and research progress with current and future Investigator Initiated Trials (IIT).
• Coordinates with Medical Communications and Publications on effective use of current and future evidence on Dendreon products.
• Collects, monitors, analyzes and presents to departmental head and to partners within the company metrics of Medical Information activities (fulfillment of Medical Information Requests for example)
• Ensures that all activities are fully compliant with existing SOPs within, and that field staff comply with applicable scientific exchange guidelines and standards.
• Compiles, develops and submits routine and ad hoc internal and external reports.
• Travel requirements include up to 50%, with overnight stays necessary.
• Other duties as assigned.

Scope:

• Provide consistent and professional supervision over field based medical personnel and provide direct and specific work assignments and tasks to direct reports.
• Manage new and effective approaches to scientific engagement, including use of new information technology, communication platforms, and visual data tools to provide factual and fair balance medical information to healthcare professionals upon unsolicited request.
• Organize, manage and deliver, when appropriate, scientific presentations and/or product updates to healthcare professionals and/or decision makers using medical and legally approved materials related to Dendreon product efficacy, safety, costs and real-world effectiveness.
• Communicate with study investigators on ongoing clinical trial requirements and data.
• Foster strong relationships with both community and academic based practices to improve, communication and relationships between the prescriber healthcare professionals and Medical Affairs organization.
• Support the identification and development of up-and-coming Key Opinion Leaders.
• Build and maintain working relationships with internal business partners to successfully accomplish assigned direct and indirect work responsibilities.
• Oversee and assess appropriate MSL documentation and activities such as HCP interactions, site visits, and conference/scientific meetings.
• Maintain and ensure accuracy of Dendreon’s documentation files and/or databases.
• Develop and maintain accurate Dendreon reports and templates as requested.
• Adhere to all compliance and operating procedures per Dendreon’s current policies.

Qualifications

Job Requirements:

• Advanced Academic Degree (i.e., MD, PhD, PharmD, DO) or equivalent.
• 6 years of related experience in a pharmaceutical/biopharmaceutical/life sciences industry or equivalent academic background.
• Demonstrated analytical abilities including, independent decision-making and problem solving informed by emotional intelligence [self-awareness], scientific knowledge, business acumen, and professional judgment.
• Proven leadership skills, including strategy development, team building, organizational, communication and interpersonal skills, with demonstrated outcomes in situational leadership with direct reports.
• Advanced knowledge and understanding of relevant clinical practices and guidelines in oncology and related disciplines.
• Strong strategic decision-making abilities related to organizational and team effectiveness.
• Proven ability to interpret customer needs as well as negotiation and influence skills.
• Strong organizational, planning, and business acumen skills.
• Proven ability to interpret customer needs as well as negotiation and influence skills.
• Ability to simplify complex concepts and communicate to diverse audiences.
• Ability to produce concise and simple summaries of concepts and solutions.
• Able to cope under pressure with sometimes conflicting priorities.
• Ability to build effective relationships within the company and with external partners, at all levels, from clinical staff, HCPs, to C-suite executives.
• Demonstrated ability to work effectively in a cross-functional, team environment across various departments within Dendreon.
• Proven ability to manage multiple priorities, exercise sound judgment, be well organized, take initiative, be flexible, work well under pressure and produce accurate and timely work.
• Excellent written and verbal communication skills, with strong presentations skills (online and in-person) before top management, external groups/organizations and internal staff.
• Knowledge of current federal, state laws and regulations that apply to the practice of nursing services.
• Strong organizational, planning, and business acumen skills.
• Solid project management skills with the ability to manage multiple large projects simultaneously.
• Proficient in all MS Office applications (WORD, EXCEL, PowerPoint).

Working Conditions and Physical Requirements:

• Dendron Pharmaceuticals LLC is an EEO/AA employer M/F/D/V.
• Dendreon operates in a fast-paced, patient-centric, and competitive environment. Team cohesiveness, direct and specific communication, and independent problem-solving are essential to succeed in this position.
• While performing the duties of this job, the employee is regularly required to sit, stand, walk, and use hands to operate a computer keyboard, mouse, and mobile phone.