Executive Medical Director

Intellia Therapeutics Cambridge , MA 02138

Posted 2 weeks ago

At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.

SUMMARY:

The (Senior) Medical Director will be acting as clinical development leader overseeing activities for ATTR program or other assigned projects, including providing strategic leadership for clinical research and data generations and product launch in US. S/he will also be responsible for the development and execution of clinical research studies and medical plans supporting assigned projects and aligning them with overall business goals. A significant portion of time will be externally-facing, and the (Senior) Medical Director will provide therapeutic area/product expertise in rare disease and oncology. The successful candidate will understand principles of medical judgement, as well as physician concerns, and patient perspectives around new CRISPR-mediated medicines. Working closely with the VP, clinical development and cross-functional colleagues, s/he ensures that the Clinical development plan is in line with brand strategies and helps support successful product development, medical launch, and commercialization.

RESPONSIBILITIES:

  • Lead the development and execution of US medical strategies and tactics for assigned clinical research projects, publication planning, and advisory boards.

  • Lead clinical safety assessment for assigned projects.

  • Interface with relevant functions (e.g. discovery, preclinical development, regulatory, clinical operations, etc.) to design and execute clinical development plans for assigned projects.

  • Leads data generation/analyses and ensures medical and scientific accuracy of manuscripts and abstracts/posters.

  • Plans publication strategy.

  • Provides medical leadership and input on labeling and regulatory interactions.

  • Provides medical education and training to internal and external stakeholders.

  • Support activities related to safety evaluations and reporting requirements.

  • Provide medical information on existing and emerging data, in response to questions from internal and external stakeholders.

  • Provides medical leadership and support for in-line Commercial Development activities including promotional message development and product training for the salesforce in preparation for US launch.

  • Lead the development, presentation, and execution of medical operating plans and strategies.

  • Applies clinical knowledge as required.

QUALIFICATIONS:

  • Doctoral degree (M.D.) or foreign equivalent.

  • Completed post-graduate medical education and is US board certified (or foreign equivalent) in a medical specialty in gene therapy or metabolic disease strongly preferred.

  • Significant industry and research experience, minimum of 3-4 years (5-7 years for senior medical director) of experience in clinical and/or health services research; preferably in industry setting.

  • Knowledge and experience in gene therapy, rare disease, and oncology preferred.

  • Understanding of the drug development process.

  • Knowledge of health care economics and its impact on medical decision making.

  • Strong analytical skills.

  • Professional demeanor and excellent interpersonal skills when dealing with external customers/internal colleagues.

  • Customer-oriented approach and ability to work in cross-functional teams.

  • Proven strategic thinking skills and ability to interpret and implement strategic directions.

  • Ability to manage multiple tasks and deal effectively with deadlines.

  • Creativity, resourcefulness, high energy, and flexibility.

  • Excellent verbal and written communication skills.

  • Networking and negotiation skills.

  • Strong business acumen.

What Intellia Stands For?

At Intellia, our mission is to develop potentially curative genome editing treatments that can positively transform the lives of people living with severe and life-threating diseases.

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

  • One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us trusting and counting on every single one of us.

  • Explore because we seek new ways to tackle disease. Explore with unbounded mindsfree from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

  • Disrupt by thinking courageouslyand creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughtswith that breed of skepticism that shows you have better solutions.

  • Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standardseven when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Executive Medical Director GI

Takeda Pharmaceuticals North America

Posted 2 weeks ago

VIEW JOBS 8/31/2019 12:00:00 AM 2019-11-29T00:00 By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's Privacy Notice, Privacy Policy and Terms of Use. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Executive Medical Director on our GI Therapeutic Area Unit in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Responsible for ensuring ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the TA leader prior to their review and approval by appropriate governance committees. Oversees the development and execution of the Integrated Development Strategy (IDS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses and Critical Study Flash Results. Provide leadership and oversight of respective region development activity. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area. ACCOUNTABILITIES: * Accountable to Therapeutic Area Head and Regional Clinical Science Head to provide strategic clinical input with emphasis on regional input. * Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed. * TA advisor supports the Development TA leader on all global objectives and ensures that the regional view is represented in the global strategy by: o Providing regional clinical leadership and oversight within TA o Managing GDT leaders within respective region(also, may serve as GDT leader as needed) o Integrating and consolidating regional input from all relevant parties into the global view on TA development issues o Providing strategic input into global development strategies and plans for all compounds in respective TA. Regional aspects are of particular focus o Member of the PDD TA Leadership Team (TALT) o Representing PDD at TA Unit as advisory member or as delegate for the PDD TA Head as requested by the TA Head o Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities) o Primary interface with regional Medical Affairs for regional strategy and in support of product commercial efforts o Contributing to the creation and maintenance of regional KOL network o Providing recommendations for GDT leader nominations and reviewers of external compounds to TA Head Liaison with Clinical Operations and Project Management for co-ordination of logistics study planing and implementation o May line manage other clinical science staff within TA aligned teams in region * Synopsis / Protocol Development, Study Execution, & Study Interpretation o Consistent with membership of the TGRD Synopsis Review Committee, responsible for critical review of Synopses relating to studies in assigned compounds. . * Trial Medical Monitoring o Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. * External Interactions o Oversees and leads all clinical science activities involved in interactions with FDA and key opinion leaders relevant to assigned compounds. o Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment. o Proactive identification of challenges and development of contingency plans as appropriate. * Due Diligence, Business Development and Alliance Projects o Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment. o Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities. o Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner. o Assigns and manages clinical science staff who are involved in many of these activities. * Leadership, Task Force Participation, Upper Management Accountability o Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area. Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area. o Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: MD strongly preferred or internationally recognized equivalent with minimum 10 years pharmaceutical research experience, including minimum 7 years phases I-IV experience. * Management experience in a matrix environment. TRAVEL REQUIREMENTS: * Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. * Requires approximately 25 % travel. WHAT TAKEDA CAN OFFER YOU: * 401(k) with company match and Annual Retirement Contribution Plan * Tuition reimbursement Company match of charitable contributions * Health & Wellness programs including onsite flu shots and health screenings * Generous time off for vacation and the option to purchase additional vacation days * Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda Pharmaceuticals North America Cambridge MA

Executive Medical Director

Intellia Therapeutics