The patient is at the heart of what we do.
PhaseBio is developing specialized, highly innovative therapies for patients with serious cardiovascular diseases. We are determined to overcome the lack of new treatment options for cardiovascular disease and provide superior outcomes for patients and healthcare systems. Driven by high-quality science, we leverage our team's deep expertise to rapidly develop and commercialize our pipeline of unique medicines.
Title: Head of Medical Affairs
Report to (title): CMO
Location: Malvern - 3, PA
Supervisory Responsibility: Not currently, but in future yes
FLSA Status: Exempt
Position Type: Full-Time
Travel Required: Some
Expected Hours of Work: (include any mandatory meeting times with time zone) ~40hrs/wk
The Head of Medical Affairs will develop and build a Medical Affairs organization and platform to be utilized primarily in the US and potentially globally. This position will work closely with a cross-functional group that includes counterparts in Research & Development and Commercial to implement and ensure a well-integrated Medical strategy. The Head of Medical Affairs will have primary accountability in building PhaseBio's Medical Affairs department and will actively participate in strategic planning for ongoing and new development and commercial projects, existing and future corporate alliances, and partnering discussions.
Essential Duties and Responsibilities
Build out and lead the medical affairs function to support commercial launch plans of new products into the marketplace.
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 Medical Communication and Disease Awareness strategies.
Collaboratively develop and execute life-cycle management plans with Commercial and R&D teams
Partner with KOLs to gather information on therapeutic area issues and questions.
Collaborate with the Clinical Development and Commercial teams to develop innovative, compliant, and on-strategy educational materials for providers and patients
Provide expertise on government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.
Collaborate with Commercial teams, KOLs, internal and external consultants, and other stakeholders to 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 executive leadership team to develop, refine, and implement strategic plans PhaseBio 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 PhaseBio Pharmaceuticals in the context of conferences, presentations, industry, and investment groups
An MD, PhD, PharmD (or equivalent) degree is required in addition to 10+/15+ years of experience in late-stage development, Medical Affairs, and/or commercial experience in the biopharmaceutical industry.
Experience as a Sr. Director or above executive
Proven experience in leading and collaborating with teams and individuals in a global, matrixed environment
Accomplished, strategic Medical Affairs executive from the biotechnology or pharmaceutical industry with an outstanding record of accomplishment in building and leading high-performance organizations and partnerships.
Experience in cardiovascular and critical care medicine is preferred but not required.
A solid understanding of the industry's complex medical affairs, regulatory, market access requirements with an absolute commitment to conducting business on the highest ethical level is essential.
Education, License, Certification, or Preferred Qualifications
A minimum of five years of management experience.
Ability to recruit, manage and develop cross functional project teams.
Ability to attract and develop talent, build 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.
Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in multifunctional teams
Proven ability to develop internal relationships in a highly matrix environment, as well as external relationships with Key Opinion Leaders and industry experts.
Tools and Technology Used
Work Environment & Mental and Physical Requirements
This job operates primarily in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and other common office equipment and accessories.
Ability to remain in a stationary position; move; operate and use required equipment; and reach items
Ability to move/transport up to 30 lbs., and up to 50 lbs. occasionally.
Ability to communicate, converse with others, and exchange information
PhaseBio is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic protected by federal, state, or local laws. If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment requirements, or otherwise participating in the employee selection process, please direct your inquiries to the HR Department by calling the PhaseBio main line at 610-981-6500.
Applicants have rights under Federal Employment Laws:
EEO is the law poster: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf
Employee Polygraph Protection Act poster : https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf
Family and Medical Leave Act (FMLA) poster: https://www.dol.gov/agencies/whd/posters/fmla
Please note this description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required. It is subject to change at any time.
This job description does not constitute an implied or express contract for employment and does not guarantee employment. Employment is at-will.
We are not able to sponsor visas. PhaseBio is not an E-Verify employer and therefore cannot employ OPT individuals.
PhaseBio does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company or to this posting without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.
Phasebio Pharmaceuticals Inc