Associate Director Medical Information
Medical Affairs | Los Altos, CA or 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
The Associate Director Medical Information (ADMI) is accountable for the execution of US and global medical information activities in Hematology as well as contributes and implements the department strategic imperatives and objectives. The ADMI is accountable for pre- and post-launch plans with internal stakeholders in Medical Affairs (US and Global), Commercial, Regulatory, Scientific Communications, Clinical Development, Health economics and Patient safety. Success of this individual is highly dependent on the ability to collaborate cross-functionally and understand the medical/business strategy.
Essential Duties & Responsibilities:
· Accountable for leading the US and Global MI contribution with planning, prioritization and execution in alignment with internal stakeholders to ensure launch preparedness in the dissemination of medical information. Also, accountable as follows:
o Scientific Content/Brand Support Accountable for US and Global MI
o Working alongside Director of MI, contribution including promotional review (US market only) by:
o Providing strategic scientific consults on brand messages and medical messaging
o Reviewing promotional materials for scientific content and accuracy
o Coordinate development, review and approval of clinical Data on File Packets to support promotional claims and medical as required
o Provide medical/scientific expertise to commercial teams for appropriate disease and product claims in development
o Represents medical function in the Medical and Promotional review committees as required (alongside the Director of MI and/or Medical Physician) and ensures scientific, medical, clinical accuracy, relevance and completeness of data and that promotional claims within materials are adequately supported by data
· Develops/maintain current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Oncopeptides products and disease states
· Lead/Manage contractors, vendors and the call center activities/personnel as appropriate to fulfill the objectives in US and Global Medical Information
· Management and experience with various platforms including Veeva Vault MedComms, Veeva Vault Promomats, Microsoft Teams, etc.
· Support the MI group planning and follow-through process for congresses, including Medical Information booths and scientific booths
· Contribute to and or lead the development, review and maintenance of Medical Affairs scientific materials, including Managed Market documents (i.e. AMCP dossier, support business impact model that is led by Health Economics and outcomes team), in collaboration with Medical Affairs colleagues
o Incorporate customer insight to identify, update, and develop scientific materials
o Coordinate with Medical Affairs colleagues, outsource providers, and vendors (as needed) to develop content
o Content includes standard response documents, slide decks, Q&As, FAQs
· Support the development/submission of the NCCN/Compendia Pathway and any other submissions as appropriate
· Customer Engagement
o Manage and assist with leading call center plans/activities, lead on providing training/updates and communications as appropriate
o Respond to medical inquiries and engage in appropriate scientific information exchange with Health Care Providers via multiple channels (i.e. verbal, written, live at congress MI booths).
o Manage accurate, focused, and scientifically balanced clinical and scientific information exchange with Health Care Providers that support the appropriate use of Oncopeptides products.
o Utilize multiple approved technologies to engage customers in appropriate scientific exchange
o Identify, analyze and/or report trends in medical and scientific insight (including medical inquiries) to Medical Affairs stakeholders
· Assists in the development and maintenance of departmental policies, standard operating procedures (SOP) and working instructions (WI) and adheres to all policies and regulations
· Lead or participate in projects/initiatives within US or Global MI and across functions as assigned
· Provide mentorship and guidance to new hire personnel
· Advanced scientific degree in pharmacy (Pharm.D.) or related science (PhD, MD) with 3-5 years of medical information in the pharmaceutical or biotech industry
· Thorough knowledge of the regulatory and compliance requirements/limitations applicable to medical information, as well as advertising/promotional and non-promotional materials
· Experience leading medical information or medical communications for a product launch
· Excellent written and verbal communication skills
· Demonstrated ability to achieve aligned objectives in a matrixed environment
· Team player in a multidisciplinary, cross-cultural environment, high level of flexibility
· Strong skills in project planning, courageous/challenging decision-making, problem-solving, and negotiating towards mutually beneficial outcomes
· Highly proficient with Microsoft Office Suite
· Ability to travel to meetings/conferences (including internationally) approximately 20% of the time
· Experience providing medical information support within a US and Global function
· Cross functional MA experience (i.e. scientific communications, training, global, etc.)
· Training or experience in the assigned therapeutic area of Hematology
We will consider remote candidates.