US Medical Strategy Lead – Immunology Biosimilars Job

Upper Gwynedd PA
Oct 04, 2016
Oct 20, 2016
Organization Type
US Medical Strategy Lead – Immunology Biosimilars-MED002516


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The US Medical Affairs Strategy Leader (MASL) holds primary responsibility for the adaption of the Global Medical Affairs Plans for their assigned assets to the US market. The MASL co-chairs the US Medical Affairs Team to establish the medical strategy and ensure execution of agreed medical tactics. In addition, the MASL contributes substantially to and is a valued co-strategist on cross-functional teams, specifically US Brand Teams and assigned Product Development subteams. The MASL co-develops a Clinical and Value Evidence Communication Platform for their assets and leads integrated data generation planning relevant to the US. The MASL demonstrates influence in the external scientific community via peer-to-peer engagement with top scientific leaders and executes expert input forums to remain on the leading edge of therapeutic and patient care advances. The MASL collaborates successfully and leads resolution of regulatory, reputational, ethical, and other asset management issues.

Asset Management & Business Leadership

- In innovative ways, translate the Global Medical Goals and Strategies into research, data analysis, scientific communication, educational, and other tactics and solutions that improve patient outcomes and enhance access in the US.
- Contribute substantively to and be a valued co-strategist on asset cross-functional meetings: Regional Franchise Teams, Clinical, Value-Evidence and Commercial Product Development Subteams
- Lead towards integrated data generation plans, propose study concepts and co-develop clinical and outcomes research projects with MRL that address product life cycle management needs in the US. Advise on areas of interest for the Investigator-Initiated Study Program of relevance.
- Develop a Clinical and Value Evidence Communication Platform for Med Affairs that effectively represents the asset’s data and value proposition and addresses key stakeholder audiences (payers, HCPs and patients).
- Support execution of and quickly adapt portfolio of tactics to business realities (ie prompt deployment of new information to the field medical staff, identify data analysis needs, and publication needs)

Scientific & Technical Leadership

- Infuse US perspective into development of the Global Medical Affairs Plan (GMAP)
- Communicate both scientific and business needs credibly and effectively across a variety of internal and external stakeholders at all levels
- Contribute to the Merck Investigator Study Program Review Committees.
- Demonstrate influence with the external scientific community through peer-to-peer interactions, research and educational collaborations, publications, or other.
- Provide therapeutic/functional training to assigned teams and affiliates
- Develop and execute regional medical educational programs, advisory boards and symposia
- Participate in and contribute significantly to internal or external trade, professional organizations, academic or regulatory working teams

Asset Regulatory Management

- Successfully collaborate and lead resolution of Regulatory, Reputational (ie Public Relations), Compliance and other Asset issues management
- Collaborate in the successful management of asset safety or quality issues, ie contribute content and strategy in regulatory responses and interactions, risk management planning and implementation



- Required: MD, PhD or PharmD


- Recognized expertise through a minimum of five (5) years clinical and/or research experience (incl publications) in autoimmune Disorders/inflammatory disease and use of TNF Blocker medicines.
- Minimum four (4) years pharmaceutical (or related) healthcare industry experience in country with proven track record of contribution to medical, clinical or commercial strategies in country
- A technical understanding of biological products and biosimilars
- Strategic thinking, specifically related to the development of Medical Affairs Goals and Strategies that address asset value proposition, and clinical and value evidence.
- Customer expertise especially scientific leadership and other key stakeholders (public groups, government officials, medical professional organizations) in therapy areas
- Proven ability to effectively influence company decisions
- Proven ability to effectively communicate information at management level, with public groups and to scientific leaders.
- Excellent interpersonal, analytical, communication (written as well as oral) and results oriented project management skills.
- Strong prioritization skills and ability to understand how decisions fit into the broader context of corporate strategies
- In a matrix environment, able to effectively collaborate across divisions


- Specialty training and clinical experience in in autoimmune Disorders/inflammatory disease
- Strategic thinking, specifically related to life-cycle management strategy and execution
- Experience in market access/health economy is an asset

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job: Medical Affairs Generic

Job Title:Dir, Medical Affairs

Primary Location: NA-US-PA-Upper Gwynedd

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: No

Company Trade Name:Merck