Head of Medical Affairs - Remote

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY

The Head of Medical Affairs provides strategic leadership to the Medical Affairs function, guiding thought leadership, pre- and post-marketing activities, and medical affairs management across multiple commercial products and government medical countermeasures. This role is responsible for the medical oversight of product labeling and promotional material reviews, ensuring compliance and scientific integrity while delegating responsibilities as appropriate.

The Head of Medical Affairs ensures seamless integration of pre- and post-marketing safety surveillance with Medical Affairs initiatives, driving a proactive approach to risk management. As a key external representative, this individual serves as an ambassador at scientific and industry meetings, strengthening the company's presence and engagement within the medical community.

As a member of the R&D senior leadership team, the Head of Medical Affairs provides corporate oversight in the development and execution of Medical Affairs strategies. This role also leads the organizational planning and operations of the department, ensuring alignment with broader business objectives and regulatory expectations.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Leadership & Strategy

* Lead a multidisciplinary team of Medical Affairs leaders supporting products across Medical Countermeasures, opioid misuse (Narcan), and emerging infectious diseases.

* Serve as a key expert in clinical and regulatory strategies, including promotional, CMC, developmental, and compliance considerations related to pharmaceutical development, commercialization, and manufacturing.

* Collaborate with commercial leadership to ensure appropriate disease and product education across the portfolio.

* Provide strategic input to R&D and Clinical Development teams for life cycle management planning.

* Integrate Medical Affairs and Pharmacovigilance activities into a proactive, state-of-the-art approach to pre- and post-marketing risk management.

* Establish department goals and strategy in collaboration with relevant business units, ensuring alignment with corporate objectives.

* Secure and allocate necessary resources to meet department goals while managing the budget effectively.

* Represent and promote the company externally, engaging with regulatory agencies, professional organizations, and business partners.

* Participate in steering committees, strategic collaborations, and clinical development review meetings across therapeutic areas.

* Provide expert consultation and partnership for commercial products, including oversight of promotional review strategies to ensure compliance.

* Ensure product labeling is developed and maintained in compliance with regulatory requirements.

* Lead the development and execution of Medical Affairs strategies for both development-stage and commercial products, supporting Emergent's mission to protect and enhance life.

Medical Affairs Responsibilities

* Drive Key Opinion Leader (KOL) engagement and education initiatives.

* Develop and implement medical messaging and product-specific strategies.

* Actively participate in Medical and Commercial Advisory Boards.

* Support speaker identification and training, as well as onboarding and training of new Sales personnel.

* Oversee and contribute to primary and secondary product publications.

* Lead medical meeting and congress planning, including abstracts, posters, and oral presentations.

* Provide full oversight of product lifecycle support, including annual planning, investigator study support, and Phase 4 studies as needed.

* Serve as a key partner to Regulatory Affairs and Clinical Development to ensure regulatory compliance and strategic alignment.

* Act as a core member of the product development team to advance products effectively and position them for success.

Organization & Operations

* Lead a team of Medical Affairs leaders, fostering collaboration across business units.

* Optimize Medical Affairs processes to ensure regulatory compliance, operational efficiency, and adherence to company policies.

* Promote a culture of engagement, productivity, and collaboration within Clinical Development and Medical Affairs.

* Facilitate the effective exchange of clinical and scientific information with both internal and external stakeholders.

* Build and maintain strong relationships with the scientific community and establish KOL networks in key therapeutic areas.

* Contribute to the company's publication plans and serve as chair of the publication planning committee.

* Develop and implement effective and compliant risk management plans for investigational and marketed products.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

* MD with 10 years of Medical Affairs experience, demonstrating successful leadership in medical affairs, KOL management, medical science, pharmacovigilance, and publication management.

* Experience supporting both commercial and clinical programs across multiple therapeutic areas, with an emphasis on infectious diseases and opioid overdose.

* Established network among Key Opinion Leaders in the infectious disease and/or opioid use disorder fields, both in the U.S. and internationally, is preferred.

* Strong ability to critically interpret and apply scientific and clinical data to develop innovative disease management strategies.

* In-depth knowledge of the regulatory and legal landscape for drug development and commercialization in the U.S. and globally.

* Comprehensive understanding of the healthcare market, including payer, provider, and regulatory dynamics in the U.S. and internationally.

* Proven ability to navigate and collaborate within strategic alliances and joint ventures.

* Leadership experience working effectively across cross-functional teams, including Commercial, Clinical Development, Business Units, Regulatory Affairs, and Strategy.

* Demonstrated success in people management and leadership development.

* Strong medical orientation with a commitment to scientific and ethical integrity.

* Excellent verbal and written communication skills, with the ability to convey complex medical concepts to diverse audiences.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $267,500 to $323,600. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.