Director of Medical Affairs
Medical Affairs | Waltham, MA | Full Time
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Melflufen is in development as a new treatment for the hematological cancer multiple myeloma and is currently being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Oncopeptides’ US headquarters is based in Waltham, MA with an office in Los Altos, CA, and global headquarters is in Stockholm, Sweden. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com
Reporting to the US Head of Medical Affairs, the Director of Medical Affairs is responsible for all activities related to conceptualizing and implementing medical brand planning strategy, achieving business targets and reporting with Oncopeptides.
This position is based in Waltham, MA
Domestic and international travel up to 20%.
Essential Duties and Responsibilities:
In collaboration and alignment with Marketing, lead the development of the Melflufen medical brand plan
Medical-Commercial interface and relationship between Medical Director and Head of Marketing
Ensuring alignment of the overall brand plan between medical and commercial activities, including ensuring all activities are in compliance with industry standards
Organizes and leads regional / national medical advisory boards in collaboration with key stakeholders in Clinical Development, Medical Affairs, and Commercial
Steering Committee, Cooperative Groups
Ensuring alignment with key internal stakeholders,
In coordination with the Commercial/Marketing and Medical Affairs Field teams, maintain a high profile with key accounts and compliantly support Commercial/Marketing activities with key centers in the delivery of medical initiatives, trainings and programs
Ensure medical initiatives are implemented in a compliant fashion as per industry regulations
Serve as the OP clinical Melflufen expert for presentations/interactions with regulatory bodies, payer groups, KOLs and other decision making groups as needed
Provide medical review and sign off for
Medical Information documents (e.g. standard response letters, FAQs) for use
promotional and non-promotional materials for use.
Works closely with Pharmacovigilance ensuring accurate and timely safety reporting
Work with regulatory affairs in guiding the regulatory strategy
Provide input into the selection of clinical trial sites for OP sponsored trials.
Provide input into the protocol synopses, study protocols and final study reports for phase IV trials and ensures clinical trial activities are consistent with product strategy
Review IIT submissions for medical relevance and strategic alignment
Provide medical input into the publications strategy
Supports payer activities (communicates medical part of the value proposition)
Experience, Education, Training, Traits:
Previous practice as a physician in the USA
7-10 years experience in pharmaceutical or biotech (preferred) companies, 3 years in medical affairs preferred.
Knowledge of local pharmaceutical industry and legal/health system environment
Previous experience in developing and leading Advisory Boards
A prior record of interface with regulatory and payor bodies
Knowledge and experience in hematologic oncology is desired
Medical and Scientific excellence
Excellent communication and presentation skills
Analytical skills and strategic thinking
Broad skill set in Medical Affairs including knowledge of clinical development, drug safety and regulatory affairs and healthcare compliance requirements
Strong customer orientation, science based and with robust business acumen
Continuously expanding medical and scientific knowledge, market knowledge as appropriate as well as regulatory and relevant government stakeholder insights
Results oriented and delivery against set goals
Medical scientific integrity and highest ethical standards.
Tenacity and perseverance to help overcome individual and group challenges.
Ability to work independently and be a self-starter, as well as functioning effectively in a matrixed environment.
Strong concept of team and ability to support team work for internal and external gain.
High sense of urgency and commitment to excellence in the successful achievement of objectives
Capacity to work irregular hours, travel and attend weekend professional programs.