Job Purpose:
Reporting to the VP of US Medical Affairs (USMA) - Oncology, the Director, USMA - Oncology, will serve as an internal medical and scientific subject matter expert for Blue Earth Diagnostics, Inc.'s USMA Department. This is a multi-faceted role where the Director will contribute to the strategy development and execution of USMA activities supporting both commercialized products and developmental assets. This individual will actively contribute to all aspects of new product support and play a critical role in promoting and maintaining professional relationships with key national and international medical experts, as well as supporting the field medical and patient advocacy teams in its initiatives. He/she will provide medical and operational oversight of Medical Affairs-led research initiatives via the Investigator-Initiated Trials (IIT) program, and provide USMA representation and support to company sponsored clinical trials. He/she will also work within the USMA Medical Information team by providing medical oversight and serving as the primary SME.
The successful candidate will be comfortable working in a smaller corporate environment and be skilled in accomplishing stretch objectives in a quick-paced, patient-focused culture.
This position will operate on a hybrid work schedule, with the expectation of working onsite 3 days a week in our office located at 197 First Avenue, Needham, MA.
Main Responsibilities, Activities, Duties and Tasks:
• Provide medical oversight, and assist and support management, of the BED IIT program
• Provide USMA representation and support across multiple company sponsored clinical trials / global development programs, including assisting and advising on investigator and site selection, liaising with KOLs/investigators, assisting with insight generation as required to support these initiatives.
• Participate in strategic planning in a multidisciplinary setting involving clinical development, R&D, regulatory affairs, and commercial functions.
• Serve as medical reviewer as part of the Promotional Review Committee (PRC) and Medical/Legal/Regulatory (MLR) review processes.
• Provide medical oversight of the Medical Information function and serve as the first medical escalation point for unsolicited requests for medical information, ensuring responses are scientifically accurate, balanced, compliant, and aligned with applicable regulations and company policies.
• Serve as a member of the USMA - Oncology leadership team, and drive USMA programs/initiatives as assigned by the VP of USMA - Oncology
• Collaborate in training sales representatives and USMA field personnel in the principles and practices of disease management for targeted clinical areas and on the attributes and clinical data regarding BED marketed products and products in development.
• Lead the planning, execution, and scientific oversight of advisory boards, ensuring the collection of high-quality external expert insights to inform medical strategy, evidence generation, and patient care initiatives.
• Establish and maintain relationships with national/international Key Opinion Leaders in US and within targeted therapy areas in conjunction with Medical Science Liaisons (MSLs) across the country
• Serve as primary contact between Medical Affairs and the commercial team to provide high level medical and scientific data/information to external clinicians/organizations as needed.
• Serve as an internal medical subject matter expert to USMA and the broader organization.
• Provide medical input into the development of field team tools and resources.
• Stay current in targeted therapy areas and with current and future competition (on market and in development).
• Proactively maintain communications with other BED Medical Affairs & Clinical Development staff within the global team as needed to advance related initiatives.
• Perform any other duties as requested by the VP USMA - Oncology and/or the senior leadership team, ensuring the smooth operation and growth of the business.
• Other duties as business requires.
Education
• Advanced scientific or clinical degree (MD, PharmD, PhD, PA, NP, MSc or equivalent).
Professional Experience, Knowledge & Technical Skills:
• Clinical care and research experience in the therapeutic areas in which BED has products/developmental assets, preferred.
• Minimum of five (5) years relevant work experience, of which at least three (3) years are within the Pharmaceutical or Biotech Industry working in Medical Affairs and/or Research & Development departments, preferably working in diagnostic nuclear medicine.
• Product launch experience preferred.
• Understanding of the clinical trials and FDA approval processes.
• Knowledge and understanding of US regulatory rules landscape (pertinent FDA Guidance for Industry), as well as Office of Inspector General and Dept. of Justice statutes and regulations; overall appreciation of the compliance landscape.
• Strong business and product marketing acumen, vision and perspective.
• Ability to comprehend and combine complex sets of data, spanning multiple projects and products.
• Ability to handle multiple demands in a fast-paced environment and to interact within the context of multidisciplinary teams.
• Excellent written and oral communication; superior presentation skills; strong analytical ability.
• Ability to interact and communicate with the highest degree of professionalism and scientific credibility with external scientific leaders (academic, government, consortia, laboratory chiefs in major institutions, etc.).
• A high level of initiative and independence.
• Travel will be required, estimated at approx. 30%. Travel will include major national conferences, advisory boards, interaction with scientific leaders and organizations (e.g. professional societies, patient advocacy), as well as annual national company meetings and departmental training sessions and retreats.
• Qualified candidate must be legally authorized to be employed in the United States.
• Excellent oral & written communication skills. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations.
Soft Skills - Company Values & Behaviors
- Autonomy, self-motivation and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment whilst working at times with ambiguity.
• Strong work ethic and humble. Strong coaching skills; as well as being a strong team player.
• Strong organizational skills with the ability to prioritize and manage multiple time-sensitive projects simultaneously.
• Strong verbal and written skills with ability to explain complex, challenging issues in a clear manner
• Strong interpersonal skills, including diplomacy, conflict resolution and flexibility, and the ability to engage and influence effectively with key stakeholders.
• Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Strong teamworking. Collaborate with various departments and provide support across all areas of the business as needed, embracing the dynamic environment of a small business.
• Strategic mindset.
The annual base salary range for this position is $200,000-$240,000.
