Director Medical Affairs USA - NYC
Science & Communication – New York City
In August 2018 Natural Cycles was cleared by the FDA as the first digital method of birth control in the U.S.
The mission of the Director Medical Affairs will be to lead the development & execution of Medical Affairs Plans for Natural Cycles in the U.S.
Develop and drive specialist medical/scientific strategies and operational implementation such as: health-care professional interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value) and educational initiatives (medical education, data, guidelines and value proposition).
Provide scientific and operational support for the Natural Cycles product launch in the U.S.; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in cross-functional teams and develops medical affairs strategies for Natural Cycles in the U.S., aligning closely with the Medical Affairs functions in Europe. Develops innovative research concepts for clinical data generation (eso. RLE); provides relevant scientific and technical training.
What you will be doing
Liaison with HCPs
- Identify, develop and maintain collaborative relationships with current and future KOLs (organize scientific meetings, discuss medical projects, studies, answer medical questions, develop speakers and brand advocates)
- Foster mutually productive relationships and scientific exchange with HCPs and KOLs, as well as relevant Medical Societies, Patient Organizations, Associations and Assessment Bodies
- Plan and implement internal and external medical trainings on therapeutic area and on the product
- Identify gaps in HCP’s current scientific knowledge and medical treatment in the area of Contraception/ FABM and develop educational strategies to close these gaps
- Support Marketing and Business teams with compliance in the areas of ethics, medical and regulatory
- Ensure medically correct content of promotional and non-promotional materials
- Support interactions with regulatory agencies
- Provide high quality support to the business: give correct and timely answers to medically related questions from the Business and participate in new product development teams
- Assist in the development of new claims based on the Instructions for Use (IFU) and clinical study data
- Support Market Access activities by providing scientific expertise for various stakeholders
- Plan and write scientific publications
- Develop and drive RLE (Phase IV) scientific studies by interacting with HCPs/ researchers and assisting e.g. with protocol development, identification of experts and subject enrolment support.
- Conduct strategic discussions regarding research to support studies for medical research and health economics and outcomes research (HEOR).
- Keep abreast of latest scientific, disease state, and healthcare landscape information and uses this information to provide value to both external and internal stakeholders
- Planning and implementation of Advisory Boards/ Expert Meetings with leading experts and other stakeholders (e.g. health policy) in the field of Women’s Health/ Contraception
- Planning,implementation and attendance of scientific events/ meetings/ lectures
- Support the development and lead the communication and roll-out of scientific data to diverse audiences including physicians, pharmacists, nurses, and other key stakeholders
- Support the development of scientifically accurate marketing materials
- Lead the development of medical education programs for HCPs and patients.
Who you are & What experience you should have
- MD degree from an accredited US or foreign medical school with at minimum two or more years of postgraduate medical training
- Board Certified in obstetrics/gynecology or related discipline is highly preferred.
- Clinical practice experience highly sought after.
- Pharm. D and Ph. D extensive medical affairs experience will be considered.
- Relevant knowledge of the therapeutic area Women’s Health, as well as the healthcare delivery systems and the healthcare environment in the U.S.
- Must have solid understanding of the relevant promotional regulations
- Strong medical affairs expertise and more than 3 years experience in similar function, e.g. in a Medical Device or Pharmaceutical company in the U.S.
- Leadership experience. The Director Medical Affairs USA will hire and lead a small team, consisting of Medical Affairs Manager and MSL
- Good knowledge of clinical trial methodology and regulatory requirements governing clinical trials in the U.S., professional experience in the planning and conduct of clinical research
- Excellent verbal and written communication and English language skills
- Energetic, committed and driven team player with a can-do attitude and a goal-oriented mindset
- Strong priority setting skills. Balancing quality with speed of execution and value of output.
- Travel (primarily within the U.S.) will be required approx. 20-30% of the work time
- Must be able to organize, prioritize, and work effectively in a constantly changing environment
- Interpersonal skills to build strong internal and external networks at all levels
- Ability to develop communication concepts (storytelling) and tailor activities and messages of complex scientific information to various audiences
- Good skills and experience with scientific data/literature review and in presenting/publishing scientific data
- Knowledge of public health/federal regulatory principles is a plus
About Natural CyclesNatural Cycles is a revolutionary approach to birth control and family planning, empowering women to take informed decisions. Developed initially by two former physicists, our algorithm and app is clinically tested and backed by several international VC firms. Natural Cycles is located in the center of Stockholm, have a great familiar atmosphere and we are a truly diverse workplace with more than 30 nationalities and 60/40 in gender diversity.
Only applications submitted through the website will be considered.