At Blue Earth Diagnostics, our mission is to transform the clinical management of patients with cancer by developing and delivering innovative molecular imaging technologies to address unmet clinical needs and reliably inform diagnosis and treatment decisions. Our team is made up of industry leaders and experts in the field of radiopharmaceuticals development and commercialization. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.
Blue Earth is seeking a US Head of Medical Affairs, to be based in the Northeast, US., who will be a strategic partner to the Chief Operating Officer – Blue Earth Diagnostics Inc. The ideal candidate will be a urologist, radiation oncologist, nuclear medicine physician or radiologist with experience in the development and/or commercialization of diagnostics, drugs or imaging agents used in patients with cancer.
The US Head of Medical Affairs will be a strategic, dynamic, highly collaborative, hands on, and successful executive who brings strong global medical affairs leadership experience for both development programs and marketed diagnostic and therapeutic products in oncology as well as strong relationships with key opinion leaders.
The US Head of Medical Affairs will provide strategy and leadership for the US Medical Affairs organization and will work closely with a cross-functional group that includes Research & Development, Commercial, Government Affairs and Corporate Communications to ensure that scientific and medical strategies are aligned with broader corporate and patient needs. S/he is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
The requirements for the position include a minimum of five years of global (including US) medical affairs experience as a proven leader within the biotech and/or pharmaceutical industry. The successful candidate will have a notable track record of scientific, medical and patient care with diagnostic and therapeutic products in oncology, radiation or nuclear medicine. S/he will not only have the ability to identify existing pathways but to help create, define and implement new medical and commercial paths that will benefit all stakeholders.
Cultural fit of the successful candidate to the company is an extremely important criterion for their success at Blue Earth. Characteristics sought for a good cultural fit include strong curiosity, intelligence, ability to think strategically and independently, ability to negotiate with and influence key stakeholders and decision makers, a “hands on” approach and attention to detail, ability to build excellent working relationships internally and externally, and an entrepreneurial spirit.
The US Head of Medical Affairs will play a key role in developing and implementing a medical affairs strategy for Blue Earth’s pipeline projects and commercial products. Specific responsibilities include:
- A detailed understanding and working knowledge of compliance under both FDA and PhRMA guidelines.
- Provide overall leadership in creating and executing US medical affairs strategies and tactical plans.
- Lead the development of the US medical affairs plan (UMAP) and associated activities including Advisory Boards, Educational Programs and Conferences.
- Hold the overall management responsibilities and leadership for the company’s US Medical Affairs organization in meeting corporate goals and objectives, while ensuring compliance with FDA and PhRMA guidelines, as well as the Company Code of Conduct and other applicable policies and regulations.
- Develop professional relationships with international and regional thought leaders to ensure access to medical and scientific information on Blue Earth Diagnostics products and areas of therapeutic interest.
- Conduct peer-to-peer scientific discussions in support of the global medical affairs plan.
- Attend scientific and medical meetings in fields of interest.
- Develop publication and communications strategy including speaker training programs and scientific symposia.
- Lead the US Medical Affairs organization by recruiting, retaining, developing and inspiring top talent.
- Conceive of and execute strategic creative methods for advancing medical affairs goals.
- Lead development, implementation and analysis of Phase IV studies and programs, and execute life cycle management plans.
- Be responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and marketed compounds; review clinical trials and community-based grants, as needed.
- Partner with KOLs to gather information on current focused therapeutic area issues and questions.
- Lead Blue Earth’s US Medical Science Liaisons (MSLs) and Clinical Applications Specialists (CAS’s) to provide appropriate education and training. Provide support, participation and insight in MSL/CAS activities, such as KOL interactions.
- Assist the Commercial team with the development of education material for providers, payers and patients that is medically accurate, and fully compliant with FDA regulations and PhRMA guidelines.
- Possess understanding of government and industry guidelines, regulations and laws for appropriate scientific/medical exchange and communication with customers.
- Integrate US Medical Affairs objectives with those of Clinical Development and Commercial Operations to ensure programs meet the needs of all constituents.
- Assist in identifying potential investigators for consideration for participating in phase I-IV clinical development programs.
- Support business development and due diligence efforts.
- Remain on the forefront of the relevant science and competitive landscape including detailed competitive intelligence.
The US Head of Medical Affairs must be a strategic business leader with proven experience introducing new products into the market and building collaborative relationships with urologists, radiation oncologists, oncologists, radiologists and surgeons. The ideal candidate will be an MD, and board certified in urology, radiation oncology, nuclear medicine or radiology with experience in the development and/or commercialization of diagnostics, drugs or imaging agents used in patients with cancer.
The successful candidate will have a minimum of 5 years of experience in medical affairs within the biotech or pharmaceutical industry. The ability to embrace and enhance Blue Earth’s culture is paramount to success in this role.
- Possesses strong knowledge of urology & oncology, and specifically a strong depth of knowledge and experience in scientific medical research and patient care. A detailed understanding of and experience in managing patients with recurrent prostate cancer is a strong plus.
- Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage stakeholders on new approaches and implement new strategies for introducing and commercializing new products.
- Broad understanding of US Medical, Regulatory and Commercial environments.
- Demonstrated record of scientific/medical publications.
- Excellent strategic skills with the ability to influence decisions at a senior level, both internally and externally.
- Ability to think innovatively about medical affairs strategy and accurately anticipate future consequences and trends.
- Ability to cultivate a high achievement organization; effective as a mentor and coach; able to attract, develop, motivate and retain key talent.
- Excellent written and oral communication skills; high-level negotiation skills. Able to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity.
- Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in an entrepreneurial setting and with diverse teams involving multi-functional disciplines. Able to organize, prioritize and work effectively in a constantly changing environment.
- Demonstrated ability in driving results to a positive outcome. The ideal candidate will have a track record of delivering outstanding results in pharmaceutical product development, commercialization and life cycle management.
- Possess the ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner.
- Strong relationship management and interpersonal skills in order to partner effectively with key stakeholders and leaders internally and externally to influence strategic direction of complex issues, solicit information, persuade others and shape outcomes.
- Flexible and dynamic interpersonal approach; entrepreneurial by nature; a collaborative team player who works well with physicians, scientists, peers and managers.
- An individual who demonstrates humility, good judgment and strong analytical skills and adjusts quickly to changes.
- Ability to travel in US and internationally.
- A desire to be part of a highly innovative company aimed at transforming the diagnosis and treatment of lives of people with serious cancers, their families and society.
- A person of the highest integrity. A thorough understanding of HIPPA, FDA regulations and PhRMA guidelines is critically important.
A medical degree (MD) is preferred. Board certification in urology, radiation oncology, nuclear medicine or radiology is desirable.
HOW TO APPLY:
To apply, please submit your CV and a covering letter with the title of this job in the subject line to firstname.lastname@example.org outlining:
- Why this role appeals to you
- How your background and skills are suited to this role
Blue Earth Diagnostics offers competitive compensation for high-caliber candidates.
Blue Earth Diagnostics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, ethnic/national origin, military and/or Veteran status, age, disability, genetics, marital status, sexual orientation or medical condition in accordance with applicable federal, state and local laws.