Job Title: Medical Affairs Director (US)
Cycle Company: Cycle Pharmaceuticals, Inc
Reports to: Chief Medical Officer
Location: The role is full time and is based at our offices in Boston (MA) however, applications for remote working will be considered. It is expected there will be some national travel to attend conferences or key meetings at specific centers. With the current COVID-19 situation, we may require you to work from home for all or part of the week.
Overview of the role
We are seeking a Medical Affairs Director who will develop and build the Medical Affairs organizational structure and platform for the company. She/he will work closely with a cross-functional group that includes her/his counter parts in Hub Services, Operations, Clinical, Regulatory Affairs, Sales and Marketing and Patient Liaison Services to implement and ensure encompassing strategy. This is an outstanding opportunity for a hands-on and proactive individual to serve as a driving force in building Cycle’s Medical Affairs presence and success, and one that will provide broad leadership challenge, accountability, and impact.
- Build out and lead the Medical Affairs function to support commercial launches of new products into the marketplace as well as existing products.
- Create and develop a best-in-class, high-performance medical affairs team and related support functions (e.g. Medical Information, MSL team).
- Identify, define and implement processes and operating procedures which are consistent with general guidance already in place for the organization.
- Develop and implement Medical Communication and Disease State Awareness strategies.
- Seek and partner with KOLs to gather information on current focused therapeutic area issues and questions.
- Collaborate with the Regulatory team to ensure pharmacovigilance processes and procedures are implemented within the Medical Affairs team.
- Collaborate with the Commercial teams for the development, review and approval of promotional and non-promotional materials and activities for providers and patients that are medically accurate and appropriate.
- Possess a deep understanding of US FDA industry rules and regulations and can act as final signatory of all materials and activities.
- Provide direction and input into the development and implementation of successful reimbursement and market-access strategies.
- Help represent Cycle Pharmaceuticals in the context of conferences, presentations, industry, and investment groups.
Qualifications and Skills
The Medical Affairs Director must be a natural industry leader with proven experience in leading and collaborating with teams and individuals. The successful candidate will be an accomplished, strategic, medical affairs professional from the biotechnology or pharmaceutical industry with an outstanding record of accomplishment building and leading high-performance organizations and partnerships. Experience in metabolic rare diseases would be highly desirable but not essential. A solid understanding of the industry’s complex medical affairs, regulatory, market access requirements with an absolute commitment to competing on the highest ethical level are essential.
More specifically, it is anticipated that the ideal candidate will possess:
- Possess a strong biopharmaceutical background with experience working in a high achievement medical affairs group, ideally in the metabolic rare disease though not essential.
- Minimum 8 years of experience in late-stage development and interphase with the commercialization of drug or biological products with experience in Medical Affairs.
- A minimum of three years of management experience.
- Ability to recruit, manage and develop new cross-functional teams.
- Ability to lead by example, attract and develop talent, build interdependent partnerships, and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility.
- Experience in drug development, commercialization of drugs and direct interaction with the FDA and international regulatory agencies is desirable.
- Able to prioritize and manage several projects simultaneously.
- Ability to work in a fast-paced and ever-changing environment, as well as a proven track record of working effectively in diverse teams involving multi-functional disciplines.
- Proven ability to develop internal relationships, as well as external relationships KOLs and industry experts.
- Able to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity.
- A desire to be part of a highly innovative and entrepreneurial global company aimed at improving the quality of life of people with metabolic and neurological rare diseases, their families and society.
- Experience in Neurology and/or Immunology therapeutic areas would be a plus.
An MD, PhD or PharmD degree is required.
Working Conditions & Environment
Employee Benefits at Cycle Pharmaceuticals:
As well as being part of a great team and doing things that will make a real difference to patients’ lives, you will get to be part of the Cycle ‘family’ and enjoy all the benefits that brings:
- Competitive salary based on experience
- Performance based bonus
- Opportunity to join a fast growing and ambitious business
- Smart office environment and vibrant working conditions
- Health Insurance
- Contributory 401k Plan with company match
- Generous paid time off (PTO)
Please submit a covering letter, CV, and Resume to CareersUS@cyclepharma.com
Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.