Head of Medical Affairs
- 100 Beaver St, Waltham, MA 02453, USA
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYSTM(KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which we have submitted a NDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease, which is currently in Phase 3 clinical development.
Kala is an emerging pharmaceutical company on the verge of commercialization. We are seeking a Head of Medical Affairs who, as a strategic partner to the Chief Medical Officer, will work closely with Kala senior management team to further create and build value at the company.
The Head of Medical Affairs will develop and build a Medical Affairs organizational structure and platform to be utilized globally. S/He will work closely with a cross-functional group that includes his/her counter parts in Research & Development and Commercial to implement and ensure an encompassing strategy. This is an outstanding opportunity to serve as a driving force in building and expanding Kala’s medical affairs presence and success, and one that will provide broad leadership challenge, accountability and impact.
The Head of Medical Affairs will actively participate in strategic planning, ongoing and new development projects, existing and future corporate alliances, and partnering discussions.
The areas of specific responsibility and attention will include the following:
- Build out and lead the medical affairs function to support commercial launches of new products into the marketplace.
- Lead, manage and develop a best-in-class, high-performance medical affairs team and related support functions.
- Identify, define and implement process and operating procedures for this group which are consistent with general guidance already in place for the development organization.
- Develop and manage a Medical Science Liaison group.
- Develop and implement Drug Safety and Pharmacovigilance capabilities.
- Develop and implement Medical Communication and Disease State Awareness strategies.
- Develop and execute life cycle management plans.
- Partner with KOLs to gather information on current focused therapeutic area issues and questions.
- Collaborate with the Clinical Development and Commercial teams with the development of education material for providers and patients that is medically accurate and appropriate.
- Possess an understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.
- Provide direction and input into the development and implementation of successful reimbursement and market-access strategies.
- Work closely with the CMO and members of the senior management team, to develop the overall strategic direction for Kala Pharmaceuticals; evaluate alternative strategies, identify competitive issues, capitalize on core strengths, and develop and implement operating plans to achieve objectives for profitable growth.
- Help represent Kala Pharmaceuticals in the context of conferences, presentations, industry, and investment groups.
The Head of Medical Affairs must be a natural leader with proven experience in leading and collaborating with teams and individuals in a global, matrix environment. The successful candidate will be an accomplished, strategic, medical affairs operating executive from the biotechnology or pharmaceutical industry with an outstanding record of accomplishment building and leading high-performance organizations and partnerships. Experience in ophthalmology would be preferred but not required. 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 ophthalmology/retinal space though not essential.
- Minimum 15 years of experience in late stage development and interphase with commercialization of drug or biological products with experience in Medical Affairs.
- A minimum of five years of management experience.
- Ability to recruit, manage and develop a new cross functional team.
- 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.
- Extensive experience in drug development, commercialization of drugs and direct interaction with the FDA and international regulatory agencies is highly desirable.
- Able to prioritize and manage several projects simultaneously.
- A visionary business leader, who can help chart the course and evaluate development and commercial options for Kala.
- Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines.
- Proven ability to develop internal relationships in a highly matrix environment, as well as external relationships with Key Opinion Leaders 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 company aimed at transforming the lives of people with serious diseases, their families and society.
An MD, PhD or PharmD degree is required.
All your information will be kept confidential according to EEO guidelines.