The Medical Director [Prostate Cancer], within Medical Affairs, will function as a scientific and medical expert for the Medical Affairs department and work collaboratively and cross functionally with their colleagues and team members at Dendreon.
Reporting directly to the Vice President of Medical Affairs, the Medical Director will provide strategic and operational direction for the development, execution and maintenance of cancer immunotherapy clinical trials, observational trials, and the interpretation of the clinical data collected.
As a senior member of the Medical Affairs team, this person will also support Medical monitoring and Clinical Operations with the Research & Manufacturing Sciences efforts to successfully complete our Phase III Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer (ProVent) [ClinicalTrials.gov Identifier: NCT03686683] and future Urologic Oncology research programs.
The role will be expected to interface with multiple cross-functional teams within Dendreon including Medical Information, Medical Communication, Real-World Evidence, Pharmacovigilance, Regulatory Affairs, Clinical Operations, Biostatistics, Commercial (Marketing, Sales, Market Access, Training), Corporate Communications, Legal/Compliance, and Research & Manufacturing Sciences on scientific and clinical research projects that support the product value and achieve our corporate goals and objectives.
An essentially part of the role will be to develop and maintain critical clinical and business relationships with external partners, academic thought leaders, and practicing physicians in the Urologic and Oncology community.
The Medical Director [Prostate Cancer] within Medical Affairs, will be a vital connector bridging together cross-functional teams from multiple departments at Dendreon to help ensure patient access to sipuleucel-T.
Provide strategic and operational direction for the development, execution and maintenance of cancer immunotherapy clinical trials and the interpretation of the clinical data collected, to include communicating with ProVent study investigators on ongoing clinical trial requirements and medical monitoring of clinical and AE data.
Develop and execute protocol for mCRPC Patient Registry for sipuleucel-T with 5-years of observational follow-up.
Help identify, effectively interact, and forge strong relationships with both community and academic based practices to improve, communication and relationships between the prescriber healthcare professionals and Medical Affairs organization.
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.
Collaborate with and provides scientific and clinical support and training for internal departments which may include Commercial (Marketing), Sales, Sales Training, Clinical Operations, Research, Legal/Policy, and Business Development.
Evaluate immunotherapy assets for contract development, license, and/or acquisition.
Interact with and makes presentations to FDA and other regulatory authorities, investigators, medical groups, vendors and Dendreon personnel
Support high-quality execution of corporate-wide initiatives
Ability to successfully work in a fast-paced, dynamic environment
Ability to work well with management, peers, and subordinates fostering an effective team spirit
The ability to analyze, negotiate, and manage/measure work including effective problem solving and systems thinking skills
Advanced degree required – MD
Requires a minimum of 5+ years of experience of subspecialty training and/or clinical/extensive industry experience in urology and/or oncology or 8+ years of pharmaceutical industry experience or equivalent previous experience working with Medical Affairs teams (level will depend on years of experience in these areas)
In-depth knowledge of study methodology, study data reviews and analysis
Experience and understanding of the drug development process
Excellent oral and written communication skills to interact with internal and external stakeholders including the ability to tailor messages to both scientific and non-scientific audiences
Passion for educating health professionals to optimize the delivery of medical care, including the appropriate use of pharmaceuticals
Must have experience and a history of successfully leading projects and people including training successful individuals, cross-functional teams, and departments
Experience in developing and making formal presentations to executive management.
Demonstrated leadership skills including a strong clinical reputation and presence
Demonstrated proficiency in presenting clinical and non-clinical data to external audiences
Strong interpersonal skills to quickly build rapport and credibility with key external stakeholder
Telecommuting is allowed.
Internal Number: 1977
About Dendreon Pharmaceuticals
Who we are.Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells. If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.What we do.Vision – Pioneering the future of immunotherapy.Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.How we do it.The Dendreon Way. We are a purpose-driven, value-based culture. At Dendreon, we…•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. •Raise the Bar: Harne...ss continuous improvement, foster innovation and elevate our people.•Drive Results. Be accountable and execute – we win when everyone performs.Primed for Growth - Contract/Partner Manufacturing Business Unit Dendreon has been working in the cellular immunotherapy space for over 10 years and brings all the experiences that comes with developing a complex manufacturing process from clinical development through to consistent commercial production. Dendreon is unmatched in its patient logistics/operational functions, manufacturing excellence in cellular therapies and commercial sales team for cellular immunotherapies. Given this expertise, we plan to leverage these strengths to grow Dendreon's pipeline of products initially through contract manufacturing for partners and then patient operations and eventually commercial sales.Are you ready?Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.