Head of Medical Affairs, Vice President
Why Join Milestone?
At Milestone, we aspire to advance and implement paradigm shifts for cardiac therapy. We are currently focused on developing anti‐arrhythmia treatments for self‐administration outside of the emergency department or hospital setting for patients with acute episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib), as well as other episodic cardiovascular conditions.
In addition to our science and innovation, we are a team guided and driven by our core values. Patient needs and empowerment are continually upheld as central to our mission. Our teamwork is strengthened in an environment in which we support and challenge each other while enjoying and celebrating our achievements. We maintain an entrepreneurial, proactive, and action‐oriented mindset that places high value on grit, courage, and resolve.
Decision‐making is based on evaluating information and an idea’s merits; data‐driven proposals are both supported and sought. We act individually and as a team with humility, candor, empathy, and unwavering integrity.
We have been successful in attracting and empowering best‐in‐class talent and we seek those with passion to join on our journey to develop treatments and to motivate change. We are excited about possibilities of this team and what we can accomplish together.
The Head of Medical Affairs (HMA) is a Vice‐President (VP) level role. The HMA develops and drives Medical Affairs strategies and is accountable for successful operational implementation. The HMA develops strategy and drives innovative late‐phase research concepts for scientific‐data and RWE generation; leads and mentors other leaders in the development of scientific and technical training, healthcare provider (HCP) / key opinion leader (KOL) engagement, educational initiatives; leads cross‐functionally to achieve corporate objectives; and effectively communicates both strategies and pragmatic tactics to internal and external stakeholders. Critically, the HMA must have excellent abilities and intrinsic comfort to collaborate across functions and to adjust communications and actions to varying situations.
Duties and Responsibilities
- Strategic and pragmatic leader for Medical Affairs Department. Set strategy for medical goals and tactics in alignment with Milestone clinical, commercial, & corporate Accountable for implementing strategies and tactics in a timely and collegial manner.
- Serve as a senior leader of the company, including having a vocal role in establishing strategies.
- Grow and manage a Medical Affairs organization, ensuring that all activities are conducted with the highest levels of scientific rigor and in full compliance with applicable rules and regulations.
- Manage and develop leaders of Medical Affairs while also leading colleagues in matrixed Demonstrated flexibility to adjust leadership and communication approaches in varying situations.
- Build a high‐impact medical and scientific platform, including scientific exchange and partnership with KOLs, medical communication and publication plans, scientific congress activities, medical education programs, scientific advisory boards, and a post‐approval evidence generation Scientific leadership in the evolution of study data outputs to supported conclusions to summary messages and compliant communications.
- Drive creation and oversee execution of publication plan, KOL/Advisory Board Plan, Investigator‐Initiated Research Plan, and Continuing Medical Education and Grant Plan.
- Develop and execute a comprehensive medical launch plan that is aligned with the brand plan.
- Provide medical and scientific expertise and close partnership on the cross‐functional Development and Brand Teams.
- Provide Medical Affairs support of the planning and implementation of product lifecycle management strategy and tactics.
- Drive the creation of effective presentations and tools (MSL/Clinical Educator slide decks, training platform materials, etc.). Provide therapeutic expertise and high‐quality input and review of disease strategy plans, abstracts, posters, slides, manuscripts, educational materials, investigator‐initiated study protocols, advisory board meeting objectives, commercial brand plans, scientific educational grant requests, and patient advocacy grant requests.
- Provide Medical Affairs leadership to the MSL/Clinical Educator/Medical Excellence teams and overall accountability for the development and management of relationships with KOLs.
- Serve as an ambassador of Medical Affairs to interact with key external and internal stakeholders, including those in Marketing, Sales Training, Commercial, Business Development, Market Access, Clinical Development, and Regulatory areas.
- Serve as Medical Affairs representative to the MLR Review Team to ensure compliance with relevant guidelines and that scientifically and medically accurate, objective, and data‐driven criteria are employed.
Requirements, and Critical Skills and Experience
- D, PhD, MD or Advanced Nursing degree required.
- Strong medical affairs expertise and more than five years’ experience in similar function with Medical Affairs and/or Clinical Development leadership responsibilities in industry R&D (pharmaceutical or device) TA or group leadership experience is important.
- Significant leadership experience, particularly one that extends to matrixed functions, with demonstrated track‐ record of success in a variety of circumstances and challenges is strongly preferred.
- Demonstrated success and comfort in working across functions and departments, including with clinical development, scientific, commercial, and regulatory colleagues is desired.
- Experience in progressing an asset through late‐development, approval, and launch will be a plus, as will be life‐ cycle management leading to label‐extension.
- Experience and subject‐matter expertise in the cardiovascular, arrhythmia, and metabolic areas is important.
- Excellent knowledge of clinical trial methodology and regulatory requirements governing clinical trials in the US and ex‐US, as well as professional experience in the planning and conduct of clinical research is preferred.
- Experienced with scientific data/literature review and in presenting/publishing scientific data; knowledge of trial design, statistical analyses, and excellent track‐record of moving publications and study reports to completion is desired.
- Experience leading colleagues, team‐members, vendors, and external authors in scientific communications, and/or leading leaders to do the same strongly preferred.
- Excellent verbal and written communication and English language skills, comfort in presenting to a variety of audiences, and skills in reading the room; expertise in adjusting leadership and communication approaches is important.
- Ability to travel locally and internationally for project related activities, as necessary required (up to about 25%).
- Entrepreneurial and proactive, a committed and driven team player with a can‐do and a goal‐oriented mindset, a track record of ‘bringing your A‐game,’ are sought.
- Interpersonal skills resulting in impactfully leading teams of differing structures, sizes, and mixes of capabilities is important. Experience in effectively setting priorities for oneself and for team‐members in a dynamic environment desired. Experience in motivating teams even through challenges; demonstrated comfort and knowing when to hold one’s ground vs. when to seek consensus vs. when to listen is also important.
- Skills in developing and maintaining strong internal and external networks at all levels is desired.
- Knowledge of regulatory guidelines such as GCP, PhRMA code, and relevant public health, federal regulatory, and compliance principles is important.
Covid-19 Vaccination Policy: All Milestone employees, regardless of work location, must be fully vaccinated for COVID-19 including appropriate booster doses. Requests for exemption based on clear documentation will be considered.
EEOC Statement: Milestone believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law
Milestone Pharmaceuticals is an equal opportunity employer
Disclaimer: The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, but rather are intended only to describe the general nature of the position.