Job Summary & Responsibilities
The International Partnership for Microbicides (IPM) was established in 2002 to develop new HIV prevention tools and other sexual and reproductive health technologies for women, and make them available in developing countries where the epidemic has hit hardest.
As a non-profit product developer, IPM manages resources and partnerships across public, private and philanthropic sectors to develop new HIV prevention tools that advance global development and promise to save millions of lives.
IPM has offices in the United States and South Africa, and works with partners worldwide.
For more information about IPM and microbicides, please visit our website at www.IPMglobal.org.
The EVP, Regulatory Affairs (EVP, RA) reports to the Chief Executive Officer (CEO) of IPM and is a member of the executive team. As such, the incumbent plays an integral role in the organization’s strategic direction, development and future growth. The EVP, RA provides exemplary management/leadership to the organization and promotes and safeguards IPM’s organizational values and culture.
The EVP, RA functions as the company’s most senior regulatory affairs executive with responsibility for achieving regulatory approval of products and cultivating a favorable relationship with global regulatory authorities. He/she as primary responsibility for the associated programs, budgets, internal staff, and outside resources.
The EVP, RA will join IPM at a critical time in the organization’s history, with the opportunity to lead the organization’s regulatory filings in Europe, the US and leading the process in specific countries in Africa for a first-in-class drug/device.
To perform this job successfully, the EVP, RA must be able to perform each essential duty:
He/she will provide strategic regulatory guidance for IPM’s products and oversee the implementation of the regulatory strategy in all regions of the world.
Provide guidance to the CEO, Executive Team, and product development programs at IPM and its partners to achieve successful regulatory submissions.
Cultivate positive professional relationships with global regulatory authorities in obtaining their opinions and guidance, interpreting their requirements, making submissions and subsequent interactions.
Directly manage regulatory submissions, coordinating the efforts of all supporting staff.
Plan, recruit, hire and manage performance of internal staff.
Plan and execute annual budgets for Regulatory Affairs.
Contract for and manage external resources, as required.
Routinely represent IPM to high level external stakeholders, including the board of directors, donors, government officials and various stakeholders.
Identify, evaluate, and develop strategic collaborations with industry, academic, and government institutions.
Provide visible leadership for the company within the relevant regulatory communities, both locally and world-wide.
Give technical presentations at seminars, conferences, meetings, as requested.
Participate in business development activities as regulatory spokesperson.
Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:
An advanced life sciences degree; Pharm.D. Ph.D. or M.D. is required.
20+ years’ experience in drug development with increasing responsibility with at least 10 years in a senior regulatory position.
Experience in the HIV field is a plus.
Regulatory experience with foreign agencies, particularly EMA.
A strong record of performance in regulatory submissions and marketing approvals for new chemical entities, including assemblage of dossiers and experience articulating/defending submissions and successfully responding to agency issues.
Experience with regulatory aspects of Combination Products, those products comprised of two or more regulated components—any combination of a drug, device, and biological product is a plus.
International experience is strongly preferred.
Knowledge, Skills, and Abilities
Excellent interpersonal, presentation, and communication skills, with the ability to represent the company to outside constituencies.
Effective leadership and management skills.
Culturally sensitive, diplomatic and politically savvy to interact with a wide variety of constituents globally.
Proven leadership and organizational skills in staff development and project management.
Well-developed research and analytical skills. Must think strategically yet oversee tactical implementations.
Must be able to coach a diverse group of employees, identify critical milestones, and hold teams and individuals accountable for strategic objectives.
A positive, determined attitude and the creativity and resourcefulness to navigate around obstacles and achieve favorable regulatory conclusions.
Excellent verbal and communication skills.
Adherence to the highest professional and ethical standards.
Willingness to “roll-up” his/her sleeves and get the job done.
Critical Competencies for Success
Regulatory strategy: The ideal candidate will be a regulatory professional who has demonstrated the ability to devise and negotiate novel or cutting edge strategies for the achievement of regulatory milestones, in the context of FDA, EMA, and international regulatory submissions and panel hearings, for drugs; ideally first in class therapeutics or combination products. A regulatory professional, who can contribute to product portfolio management, by identifying and addressing issues with possible solutions before they have a negative impact, will be of particular value.
Influencing skills: An executive who is able to influence both external stakeholders (e.g., regulatory agencies), and internal constituents (including senior management, multiple internal functional departments, and one’s own organization), by being proactive, collaborative, decisive and a superb communicator. A professional who has the stature and credibility to arbitrate the balance between the organization’s clinical and regulatory functions as well as the gravitas and strategic mindset to work effectively with collaboration partners and external regulatory bodies will be ideal.
Flexible team leadership: An executive who has demonstrated the ability to: Operate in a semi-virtual setting, harness and hold accountable talent comprised of external consultants, collaborative partners as well as internal reports, cross-functional team members. Equally adept at managing up, down and across.
Emotional Intelligence: Ability to recognize their own and other people's emotions, to discriminate between different feelings and view them appropriately, and to engage people in a way that creates a positive and constructive work environment.
Other Personal Characteristics
Superb verbal and written communication and presentation skills to allow for the effective interaction with all relevant company stakeholders.
Excellent interpersonal, motivational and team building skills that bridge functional and geographical borders.
Natural business aptitude that will add value beyond the immediate scientific responsibility.
A personality, style and presence that will fit with the IPM culture:an independent self-starter and team player; a self-aware, mature professional; a decisive but not autocratic leader.This will be a person who can bridge disciplines and interests to achieve milestones, while also bringing out the best personal contribution from each individual.
Strong listening skills; the confidence to learn from others, distill information and draw thoughtful conclusions based on both robust domain knowledge and IPM intellectual capital.
A sense of urgency and dedication to the IPM mission.
Terms and Conditions
Position will be based out of a home office or the Silver Spring office. Position will require national/international travel. The successful candidate should expect a fast-paced working environment. IPM is an Equal Employment Opportunity employer.