CASY-MSCCN Jobs

Job Description Summary:

The Vice President, Global Medial Affairs is the head of the Global central medical functions responsible for aligning key scientific objectives of the global medical organization with the broader strategic and cross functional objectives including partnering with commercial, clinical development, regulatory, patient advocacy and other corporate support functions. This person is responsible for providing leadership to medical affairs central functions by designing, integrating and addressing the scientific interests and needs of customer stakeholders across all PTC therapeutic areas / indications. The incumbent manages a global team capable of developing programs that deliver scientific results and optimize patients' long-term health outcomes. He/she is also accountable for ensuring that programs / activities associated with the medical affairs function are conducted in accordance with applicable regulatory requirements. Central medical affairs functions include Medical Information, Scientific Communications, Publications, Patient Registries and Global Therapeutic Area leads. The Vice President, Global Medical Affairs is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description:

Responsibilities:

• Leads and drives an efficient and effective Global Medical Affairs function.
• Collaborates with the all customer facing teams, commercial development, regional medical affairs teams and cross functional representatives of other corporate functions to develop integrated Medical Affairs strategies that aligns with, and supports, PTC's global customer facing strategy and associated departmental initiatives.
• Develops and manages a global key opinion leader (KOL) strategy that supports PTC's relationships with KOLs and other external key stakeholders (e.g. academic institutions with a relevant medical / scientific community); ensures the strategies and relationships are established and maintained; responsible for hands-on development and management of peer-level KOL / key stakeholder relationships.
• In collaboration with Patient Advocacy department, may support PTC at patient advocacy group meetings or other professional medical and advisory organizations.
• In collaboration with the Clinical Development department, designs, implements and manages global registries or outcomes surveys that combines the ability to meet post-marketing regulatory commitments and other valuable longitudinal outcomes data to support and enhance product value.
• Provides medical oversight for the scientific aspects of PTC satellite symposia, medical congresses, workshops and other meetings, including speaker contacts and post-conference publications.
• Accountable for ensuring that promotional and other commercially oriented materials receive medical review / approval.
• Ensures timely and accurate medical information is disseminated to health care professionals through the management of a global medical information function.
• In collaboration with Market Access, develops strategies to present relevant medical data to commercial and government payers.
• Contributes to the development of key medical messaging and its translation into commercial messaging.
• Establishes, leads and directs the cross-functional global grants review committee that reviews / approves investigator-initiated studies and provides strategic framework to ensure that approved grant support PTC's lifecycle plans, publications plans and marketing strategies.
• Ensures that medical affairs activities are conducted in compliance with appropriate safety, environmental, financial, legal, and regulatory requirements.
• Develops and manages global medical affairs budget for central functions.
• Manages, coaches, develops and mentors direct reports.

Qualifications:

• Medical degree (M.D.), PhD or PharmD and 10 years of progressively strategic experience in medical affairs roles in a pharmaceutical, biotechnology or related environment including significant global leadership experience or equivalent combination of medical and industry experience.
• Position requires strong working knowledge of major markets including US, EU, LATAM and APAC.
• Demonstrated ability to build and manage a strategic medical affairs organization while also retaining responsibility for the hands-on execution of the associated programs.
• Demonstrated track record of success supporting the commercialization of an orphan, rare disease and/or specialized drug(s).
• Experience developing and managing a budget.
• Direct management of, and hands-on involvement in, full life cycle medical/clinical research and medical education activities for marketed biotechnology or pharmaceutical products.
• Demonstrated ability to apply medical/clinical expertise to the development of a global medical affairs function that advances the company's commercial and clinical development objectives.
• In-depth understanding of the clinical trials process with demonstrated ability to design and implement programs and initiatives designed to address specific strategic objectives.
• Experience evaluating and approving proposals for investigator-initiated studies, ensuring that they are aligned with the company's clinical and commercial strategies.
• Experience overseeing the management of study grants and study progress and monitoring.
• Hands-on experience interpreting the impact of new research findings on current medical thinking with ability to leverage this data to build and foster disease management frameworks.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills. Comfortable discussing technical scientific data to HCPs, investigators, and the overall scientific community.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience in one or more of the following therapeutic areas: genetic disorders, neurology, metabolic conditions.
• Experience in orphan/rare diseases.
• Experience managing patient registries.

Travel requirements: 30-50% Domestic and International

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, p regnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.