$180K — $275K *
SUMMARY DESCRIPTION, This position is responsible for providing regional medical leadership to haemophilia to the NORAM region, comprised of USA and Canada. This individual will be an active member of the team charged with developing hematology in our company on an accelerated timeline. This individual has a regional scope of responsibility in the Medical function and is expected to excel at aligning with colleagues across matrix/functions proactively
This individual will interface externally with healthcare professionals, clinical investigators, regulatory agencies amongst others as well as with internal company departments providing medical insights and supporting the product development strategy. Within the latter ones, this person’s responsibility will also include providing input and collaborating on other cross-functional activities and initiatives, from Commercial (Brand Management, Market Access, Sales) Patient Advocacy, Regulatory, Clinical Sciences and other departments, aligning with colleagues across matrix/functions proactively.
This person must be able to provide insightful guidance and show deep knowledge of the current status of the sciences as well as of agents in the pipeline and associated topics in gene therapy and hemophilia. This position will be the scientific reference at the regional level, representing the department and the company at key internal and external activities and events.
Responsible for direct management of projects and matrix collaboration within and outside of the department.
Responsible for the development of a Regional Medical Affairs Plan for hemophilia.
Responsible for direct interaction with investigators, KOLs and the research community to support company initiatives. Build trusted and meaningful scientific partnerships with KOLs through deep therapeutic insights and driving changes in attitudes and behaviours through scientific engagement.
Responsible for representing our company at scientific, clinical and business development meetings.
Promote effective communication between internal and external groups regarding Medical Affairs initiatives. Foster a culture of collaboration, innovation, and excellence in order to advance scientific understanding in support of the business for commercial, medical, clinical and regulatory colleagues.
Act as a key member of different internal committees ensuring NORAM input is incorporated into the global strategy.
Provide leadership and direction to staff with oversight for MAF managed programs in haemophilia, acting as a business and people leader in the organization. Lead, hire, engage, coach and develop the NORAM haemophilia team to foster high performance and the creation of a learning organization. Ability to attract, develop and retain talent within the organization in a manner that inspires ongoing commitment and enables excellence.
Responsible for management and medical input in support of key medical messaging such as core claims document, product information, etc. S/he will contribute to promotional activities for our company products being done in accordance within the respective regulatory and compliance requirements.
Responsible for providing medical input into development, execution and interpretation of clinical protocols. This includes review of draft independent research protocols, reports and manuscripts. S/he will oversee clinical registries and evaluate safety issues associated with products in collaboration with other departments. May need to assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community.
Direct medical writing activities associated with Medical Affairs to ensure accurate execution of product dossiers, product related slide decks, standard response letters, FAQs as well as corporate abstracts, posters, oral presentation and manuscripts when appropriate.
Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources
Ensure compliance with policies, SOPs, Code of Business Conduct and Corporate Social Responsibility, as well as relevant legislation and regulations
Strategic individual with operational mindset
Ability to work proactively and effectively, with exceptional creative problem-solving skills.
Able to thrive in an ambiguous and demanding environment, with high capacity for effective relationship building and teamwork.
Flexibility and adaptability. Sensitivity to a multicultural environment.
Excellent project management skills, with a drive for results coupled with the highest medical and ethical standards. High scientific curiosity and credibility.
Excellent written and oral communication skills. Able to convince, inspire and motivate people with a variety of backgrounds.
Commercially astute with proven ability to consider our company business needs holistically while developing scientifically sound medical strategies and tactics
EDUCATION, Advanced Degree (M.D. / Ph.D., or both) in Medicine and/or a medical sciences field. Experience in haemophilia/haematology highly desirable, either in a pharmaceutical/clinical research or a clinical environment. Very strong Medical Affairs experience required.
Strong industry experience, especially in Medical Affairs (≥ 7 years) and in a competitive marketplace.
Experience working in Global organizations an in heavily matrixed organizations.
Knowledgeable and current in GCP guidelines and compliance rules in US and Canada. Clinical trial and publication experience are desirable.
Demonstrate excellent medical affairs skills
Having working knowledge in the therapy area is highly desirable but not a must.
Willingness to travel (also international)
CONTACTS, Internally: Will be expected to interact on a daily basis with various members of regional commercial team, EUMEA team and Developmental Sciences team, Market Access team, Market Planning team, Regulatory team, Clinical Sciences team. S/he will be required to interact closely with Global Medical Affairs and colleagues in San Rafael, CA.
Externally: Will be required to interact with, inter alia, KOLs, payer bodies, patient associations, in collaboration with other departments.
Base Salary - $180,000 to $260,000
Salary range for Director: 180K-240K
Salary range for Sr Director: 200-260K
Relocation Assistance Available - Yes, Ideal Candidate, Candidates can be based anywhere is the US, surely we would be pleased to find someone in California area but not a requirement as the position can be remote. If candidates want to relocate, full relocation package will be provided.
7+ to 10 years experience
Seniority Level - Director
Minimum Education - Doctorate Degree
Willingness to Travel - Occasionally
Valid through: 7/6/2021
$150K — $200K *
4 days ago