Director/Senior Director, Medical Affairs

Director/Senior Director, Medical Affairs

PTC Therapeutics

Remote, Sweden

Job Description Summary:

The Director/Senior Director, Medical Affairs is responsible for providing strategic and operational leadership to the Medical Affairs function for the respective country or region of responsibility to support marketed and pipeline products. The incumbent is responsible for adapting global and regional medical affairs strategies to ensure they are fit for purpose at the local/regional level.

Job Description:

The incumbent supports and represents PTC and its products with, and to, key opinion leaders (KOL’s), clinicians, academic institutions, patient associations and professional organizations within the assigned country or region. They address the specific needs of these clients by responding to unsolicited requests for information about PTC marketed and developing products.

As the clinical and medical expert on PTC’s products, they build long term relationships and establishes rapport with local PAGs and clinicians in hospitals, clinics, and academic centres through highly scientific product and disease state discussions that support or expand current therapeutic concepts and ensures safe and effective utilization of products.

The incumbent works cross-functionally with internal departments and external resources on Medical Affairs related issues.

The Director/Senior Director, Medical Affairs ensures adherence to relevant regulatory requirements, local Codes of Practice, and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS:

• Adapts, influences and helps to shape the global, regional and country medical affairs strategy required in the country or region of responsibility;
• Thinks like an entrepreneur and aligns with colleagues across the Medical and Commercial functions;
• Interacts with local authorities, local Key Opinion Leaders (KOLs) and payors, patient organizations as well as other external stakeholders;
• Ensures execution of medical affairs strategy and builds and maintains trusted medical/scientific relationships with health community stakeholders;
• Collaborates with Marketing/Commercial/Market Access to ensure that the local strategic medical affairs plans are in line with the marketing plans/brand strategies;
• Drives the tactical implementation of medical affairs plans across the country, including but not limited to: KOL development and relationship building as well as the building of the scientific communications platform (publications, congresses etc.) and other related projects;
• Acts as the final signatory in the review and approval of promotional and non-promotional materials with regard to medical accuracy;
• Manages and directs medical information process and service in close collaboration with other functions in medical affairs;
• Manages direct requests for compassionate use of PTC medicines as appropriate for patients in Nordic, Baltic and BeNeLux countries in collaboration with their managing clinician;
• Identifies and fosters trusted relationships with local thought leaders, engages in scientific exchange and develops rapport with experts in the therapeutic area;
• Identifies, organises, and carries out regional medical initiatives (i.e., leads medical discussions at national or regional advisory board meetings);
• Provides training and scientific education to commercial, medical teams and other internal stakeholders;
• Provides support in the administration, development, initiation and conducting of clinical trials, occurring within their region on request by Clinical Development teams; collaborates and provides support to other departments, especially to Regulatory Affairs, Clinical Operations, and Pharmacovigilance (PV); represents Global Medical Affairs at local, regional and international scientific congresses;
• Manages, coaches and mentors direct reports (if applicable);
• Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• Requires a Scientific degree and a minimum of 8 years of progressively responsible, relevant experience in a pharmaceutical, biotechnology or related environment at least 5 of which have been in a medical affairs role. Position also requires prior clinical practice experience;
• Hands-on experience supporting the registration and launch of an orphan, rare disease, and/or specialized drug(s) in the country/region of responsibility;
• HTA submission experience with relevant reimbursement bodies;
• In-depth, hands-on experience working with KOL’s, clinicians, HCPs, payors, and/or academic institutions establishing/maintaining relationships and scientific/medical credibility;
• Demonstrated success in interpreting scientific data and presenting research information to scientists and HCPs;
• Experience dealing with the local regulatory authorities and payor organisations;
• In-depth experience adapting regional plans to a country orientation, while working within a global framework.

Special knowledge or skills needed and/or licenses or certificates required:

• Excellent verbal and written communication and skills, including scientific/technical writing and presentations including the ability to communicate complex technical information clearly;
• 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;
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports (if applicable);
• People and project management experience.

Apply Now

More Job Searches

Sweden      Clinical Research      Manager and Executive      Medical      Medical Advisor      Pharmacovigilance and Medical Information      PTC Therapeutics