Executive Director, Global Med Affairs - US & Global Gene Therapy Lead | BioNJ Talent Services

Executive Director, Global Med Affairs - US & Global Gene Therapy Lead

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

PTC is a science-led, global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. Founded over 20 years ago, PTC Therapeutics successfully markets rare disorder products and has a robust pipeline of transformative medicines. When you combine great causes with great people, you find a culture that thrives on collaboration and creativity. PTC is a committed group of people that have a passion for science and a strong desire to succeed in an environment that is rewarding, inclusive and respectful. Join us on our journey as you grow your career.

Job Description:

PTC Therapeutics is recruiting for a Executive Director, Global Medical Affairs - US & Global Gene Therapy Lead. The position is based in South Plainfield, NJ.

The Executive Director, Global Medical Affairs – US & Global Gene Therapy Lead is responsible for providing strategic and operational medical affairs leadership for the Gene Therapy Therapeutic Area. Collaborating closely with the Senior Vice President, Global Medical Affairs, the incumbent will adapt and influence the global medical affairs strategy for GT and, working directly with the Regional Medical Directors, ensure that it also meets local needs.

He/she also collaborates with marketing colleagues, to ensure that the strategic GT medical affairs plan is in line with the marketing plan/brand strategy. The incumbent drives the tactical implementation of the plan and works closely with regional and country medical directors for implementation. This includes but is not limited to: key opinion leader (KOL) development and relationship building, as well as building the scientific communication platform (publications, congresses etc.), planning/conducting scientific advisory boards and other related projects required for the GT therapeutic area.

He/she may manage direct report(s).

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

The Executive Director, Global Medical Affairs – US & Global GT Lead ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

• Develops, manages and leads strategic global medical affairs activities related to the GT therapeutic area to support successful product development and commercialization; drives and supports communication and collaboration amongst regional and local medical affairs functions and other teams in Research and Development (R&D), Commercial, Market Access, Legal, etc. to ensure well developed and executed GT life-cycle management strategic plans; drives internal cross-functional partnerships for all GT medical initiatives.

• Provides strategic direction and tactical guidance for medical activities of regional medical directors with respect to the GT Therapeutic area; assists in medical training and educating internal and external colleagues on the scientific and clinical aspects of the GT TA.

• Develops and finalizes global evidence generation plan in close collaboration with regional and country medical heads, and ensures alignment with other key internal stakeholders.

• Plans and leads the Investigator Sponsored Studies strategy and support the execution for the GT TA.

• Acts as Medical Lead for the Registry/PASS clinical study.

• Effectively engages and builds relationships with GT KOLs, regulatory agencies, internal and external stakeholders and healthcare professionals for the successful implementation of medical strategy for the GT brand throughout the regions; identifies and engages in scientific exchange with medical experts in the GT therapeutic area.

• Provides support, with respect to the GT TA, in the administration of clinical trials on request by Clinical Development teams; collaborates and provides support to other departments, especially to Regulatory Affairs, Pharmacovigilance (PV) and Market Access; represents Global Medical Affairs at regional and international scientific congresses; collaborates closely with the Marketing function to provide medical input for commercial activities related to GT.

• Plans and leads the publication strategy and support the execution for the GT TA; serves as GT medical consultant to organizational and department development programs and assists business development as needed.

• Supervises medical information process and service from the GT indication perspective in close collaboration with other functions in medical affairs; ensures Scientific Affairs Services offerings are appropriately utilized for the GT TA.

• May manage, coach and mentor direct reports. Provides leadership to indirect reports and colleagues within the medical affairs team working on GT.

Qualifications: 

Minimum level of education and years of relevant work experience:

• Medical or PhD Degree with a minimum experience of 10 years progressively responsible experience in the pharmaceutical, biotechnology or related environment, including minimum 5 years in medical affairs.

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

• Proven track record of successful leadership and progression within a medical affairs department working from both a strategic and tactical standpoint.

• Comprehensive understanding of the compliance issues concerning medical affairs functions.

• Demonstrated track record of success supporting the commercializing of an orphan, rare disease and/or specialized drug(s).

• In-depth experience dealing with the regional regulatory authorities and payer organizations.

• Experience building and maintaining KOL network and interacting with patient organizations.

• Ability to influence without direct authority.

• Proficiency with Microsoft Office.

• Excellent verbal and written communication and skills.

• 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.

• Fluent in English (verbal and written).

Special knowledge or skills and/or licenses or certificates preferred:

• Expertise on gene therapy

• People and project management experience.

• Experience in orphan/rare diseases, neurology and/or genetic disorders.

• Experience managing clinical trials, in particular registry studies.

Travel requirements:

40%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Medical